Trial Outcomes & Findings for Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia (NCT NCT02104817)

Participant milestones
Measure	Epanova Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo Corn oil 4 x 1 gram capsule
Overall Study STARTED	6539	6539
Overall Study COMPLETED	80	92
Overall Study NOT COMPLETED	6459	6447

Reasons for withdrawal
Measure	Epanova Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo Corn oil 4 x 1 gram capsule
Overall Study Death	363	330
Overall Study Lost to Follow-up	3	2
Overall Study Protocol Violation	0	1
Overall Study Study terminated by sponsor	5854	5901
Overall Study Withdrawal by Subject	111	78
Overall Study Other reasons	128	135

Baseline characteristics by cohort
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule	Total n=13078 Participants Total of all reporting groups
Age, Continuous	62.5 years STANDARD_DEVIATION 8.98 • n=5 Participants	62.5 years STANDARD_DEVIATION 8.98 • n=7 Participants	62.5 years STANDARD_DEVIATION 8.98 • n=5 Participants
Sex: Female, Male Female	2289 Participants n=5 Participants	2279 Participants n=7 Participants	4568 Participants n=5 Participants
Sex: Female, Male Male	4250 Participants n=5 Participants	4260 Participants n=7 Participants	8510 Participants n=5 Participants
Race/Ethnicity, Customized WHITE	5341 Participants n=5 Participants	5382 Participants n=7 Participants	10723 Participants n=5 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	180 Participants n=5 Participants	166 Participants n=7 Participants	346 Participants n=5 Participants
Race/Ethnicity, Customized ASIAN	698 Participants n=5 Participants	657 Participants n=7 Participants	1355 Participants n=5 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	114 Participants n=5 Participants	112 Participants n=7 Participants	226 Participants n=5 Participants
Race/Ethnicity, Customized OTHER	159 Participants n=5 Participants	154 Participants n=7 Participants	313 Participants n=5 Participants
Race/Ethnicity, Customized MULTIPLE	33 Participants n=5 Participants	47 Participants n=7 Participants	80 Participants n=5 Participants
Race/Ethnicity, Customized UNKNOWN	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized NOT REPORTED	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Australia	58 Participants n=5 Participants	54 Participants n=7 Participants	112 Participants n=5 Participants
Region of Enrollment Belgium	53 Participants n=5 Participants	51 Participants n=7 Participants	104 Participants n=5 Participants
Region of Enrollment Canada	187 Participants n=5 Participants	177 Participants n=7 Participants	364 Participants n=5 Participants
Region of Enrollment China	357 Participants n=5 Participants	356 Participants n=7 Participants	713 Participants n=5 Participants
Region of Enrollment Czech Republic	120 Participants n=5 Participants	108 Participants n=7 Participants	228 Participants n=5 Participants
Region of Enrollment Denmark	48 Participants n=5 Participants	73 Participants n=7 Participants	121 Participants n=5 Participants
Region of Enrollment Estonia	57 Participants n=5 Participants	53 Participants n=7 Participants	110 Participants n=5 Participants
Region of Enrollment Hungary	561 Participants n=5 Participants	562 Participants n=7 Participants	1123 Participants n=5 Participants
Region of Enrollment Italy	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants
Region of Enrollment Japan	166 Participants n=5 Participants	139 Participants n=7 Participants	305 Participants n=5 Participants
Region of Enrollment Korea, Republic Of	68 Participants n=5 Participants	65 Participants n=7 Participants	133 Participants n=5 Participants
Region of Enrollment Lithuania	170 Participants n=5 Participants	193 Participants n=7 Participants	363 Participants n=5 Participants
Region of Enrollment Mexico	152 Participants n=5 Participants	155 Participants n=7 Participants	307 Participants n=5 Participants
Region of Enrollment Netherlands	206 Participants n=5 Participants	215 Participants n=7 Participants	421 Participants n=5 Participants
Region of Enrollment New Zealand	74 Participants n=5 Participants	77 Participants n=7 Participants	151 Participants n=5 Participants
Region of Enrollment Poland	501 Participants n=5 Participants	492 Participants n=7 Participants	993 Participants n=5 Participants
Region of Enrollment Russia	307 Participants n=5 Participants	326 Participants n=7 Participants	633 Participants n=5 Participants
Region of Enrollment South Africa	471 Participants n=5 Participants	490 Participants n=7 Participants	961 Participants n=5 Participants
Region of Enrollment Taiwan, Province Of China	28 Participants n=5 Participants	31 Participants n=7 Participants	59 Participants n=5 Participants
Region of Enrollment Ukraine	1009 Participants n=5 Participants	955 Participants n=7 Participants	1964 Participants n=5 Participants
Region of Enrollment United Kingdom	377 Participants n=5 Participants	382 Participants n=7 Participants	759 Participants n=5 Participants
Region of Enrollment USA	1536 Participants n=5 Participants	1551 Participants n=7 Participants	3087 Participants n=5 Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
The Composite of Major Adverse Cardiovascular Events (MACE)	785 Number of Participants	795 Number of Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline Overall number of participants	785 Number of Participants	795 Number of Participants
The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline Number of participants with established cardiovascular disease (CVD) at baseline	569 Number of Participants	610 Number of Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
The Composite of CV Events	541 Number of Participants	517 Number of Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline Number of participants with established CVD at baseline	383 Number of Participants	385 Number of Participants
The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline Overall number of participants	541 Number of Participants	517 Number of Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
The Composite of Coronary Events	556 Number of Participants	616 Number of Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline Overall number of participants	556 Number of Participants	616 Number of Participants
The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline Number of participants with established CVD at baseline	417 Number of Participants	493 Number of Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
CV Death	228 Number of Participants	211 Number of Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
CV Death in the Subgroup of Participants With Established CVD at Baseline Overall number of participants	228 Number of Participants	211 Number of Participants
CV Death in the Subgroup of Participants With Established CVD at Baseline Number of participants with established CVD at baseline	152 Number of Participants	138 Number of Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
All-cause Death	373 Number of Participants	333 Number of Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
All-cause Death in the Subgroup of Participants With Established CVD at Baseline Overall number of participants	373 Number of Participants	333 Number of Participants
All-cause Death in the Subgroup of Participants With Established CVD at Baseline Number of participants with established CVD at baselne	234 Number of Participants	202 Number of Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
Emergent/Elective Coronary Revascularization	414 Number of Participants	441 Number of Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
Hospitalization for Unstable Angina	87 Number of Participants	104 Number of Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
Non-fatal Myocardial Infarction	218 Number of Participants	226 Number of Participants

Outcome measures
Measure	Epanova n=6539 Participants Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6539 Participants Corn oil 4 x 1 gram capsule
Non-fatal Stroke	142 Number of Participants	125 Number of Participants

Blood and lymphatic system disorders

Agranulocytosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Anaemia

0.23%

15/6532 • Number of events 17 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.29%

19/6535 • Number of events 25 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Anaemia macrocytic

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Antiphospholipid syndrome

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Blood loss anaemia

0.14%

9/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Coagulopathy

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Disseminated intravascular coagulation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Immune thrombocytopenic purpura

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Iron deficiency anaemia

0.14%

9/6532 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Leukocytosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Lymphadenopathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Microcytic anaemia

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Nephrogenic anaemia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Normocytic anaemia

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Pancytopenia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Polycythaemia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Splenic infarction

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Splenic thrombosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Splenomegaly

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Blood and lymphatic system disorders

Thrombocytopenia

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Acute coronary syndrome

0.20%

13/6532 • Number of events 13 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.12%

8/6535 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Acute left ventricular failure

0.24%

16/6532 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.12%

8/6535 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Acute myocardial infarction

0.61%

40/6532 • Number of events 53 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.69%

45/6535 • Number of events 47 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Adams-stokes syndrome

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Angina pectoris

1.4%

92/6532 • Number of events 110 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

1.6%

102/6535 • Number of events 113 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Angina unstable

1.7%

112/6532 • Number of events 125 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

2.2%

141/6535 • Number of events 162 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Anginal equivalent

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Aortic valve disease

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Aortic valve incompetence

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Aortic valve stenosis

0.09%

6/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Arrhythmia

0.18%

12/6532 • Number of events 12 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Arteriosclerosis coronary artery

0.29%

19/6532 • Number of events 23 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.23%

15/6535 • Number of events 20 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Arteriospasm coronary

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Atrial fibrillation

2.3%

150/6532 • Number of events 188 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

1.4%

89/6535 • Number of events 103 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Atrial flutter

0.21%

14/6532 • Number of events 20 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.26%

17/6535 • Number of events 20 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Atrial tachycardia

0.03%

2/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Atrioventricular block

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Atrioventricular block complete

0.11%

7/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Atrioventricular block first degree

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Atrioventricular block second degree

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Atrioventricular dissociation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Bradyarrhythmia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Bradycardia

0.12%

8/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiac aneurysm

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiac arrest

0.29%

19/6532 • Number of events 19 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.17%

11/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiac asthma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiac discomfort

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiac disorder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiac failure

1.4%

90/6532 • Number of events 117 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

1.4%

92/6535 • Number of events 132 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiac failure acute

0.41%

27/6532 • Number of events 35 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.32%

21/6535 • Number of events 25 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiac failure chronic

0.28%

18/6532 • Number of events 21 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.32%

21/6535 • Number of events 26 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiac failure congestive

0.92%

60/6532 • Number of events 83 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.90%

59/6535 • Number of events 77 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiac tamponade

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiac ventricular thrombosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardio-respiratory arrest

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardio-respiratory distress

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiogenic shock

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiomyopathy

0.14%

9/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiopulmonary failure

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiovascular deconditioning

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiovascular disorder

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Cardiovascular insufficiency

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Congestive cardiomyopathy

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Coronary artery disease

1.3%

82/6532 • Number of events 89 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.93%

61/6535 • Number of events 72 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Coronary artery insufficiency

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Coronary artery occlusion

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Coronary artery stenosis

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.12%

8/6535 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Coronary artery thrombosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Diastolic dysfunction

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Extrasystoles

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Hypertensive heart disease

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Intracardiac thrombus

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Ischaemic cardiomyopathy

0.06%

4/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.15%

10/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Left ventricular dysfunction

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Left ventricular failure

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Metabolic cardiomyopathy

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Mitral valve disease

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Mitral valve incompetence

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Myocardial fibrosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Myocardial infarction

0.60%

39/6532 • Number of events 43 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.78%

51/6535 • Number of events 51 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Myocardial ischaemia

0.41%

27/6532 • Number of events 28 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.24%

16/6535 • Number of events 17 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Myocarditis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Nodal arrhythmia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Nodal rhythm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Palpitations

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Paroxysmal atrioventricular block

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Pericardial effusion

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Pericarditis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Pleuropericarditis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Postinfarction angina

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Pulmonary valve stenosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Pulseless electrical activity

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Right ventricular failure

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Silent myocardial infarction

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Sinoatrial block

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Sinus arrest

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Sinus bradycardia

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Sinus node dysfunction

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Sinus tachycardia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Supraventricular extrasystoles

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Supraventricular tachycardia

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Tachyarrhythmia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Tachycardia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Ventricular arrhythmia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Ventricular dysfunction

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Ventricular extrasystoles

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Ventricular fibrillation

0.11%

7/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.12%

8/6535 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Cardiac disorders

Ventricular tachycardia

0.20%

13/6532 • Number of events 14 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.21%

14/6535 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Congenital, familial and genetic disorders

Arteriovenous malformation

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Congenital, familial and genetic disorders

Atrial septal defect

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Congenital, familial and genetic disorders

Cerebrovascular arteriovenous malformation

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Congenital, familial and genetic disorders

Familial mediterranean fever

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Congenital, familial and genetic disorders

Gastrointestinal arteriovenous malformation

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Congenital, familial and genetic disorders

Hypertrophic cardiomyopathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Congenital, familial and genetic disorders

Phimosis

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Congenital, familial and genetic disorders

Porokeratosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Congenital, familial and genetic disorders

Pyloric stenosis

0.02%

1/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Ear and labyrinth disorders

Deafness

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Ear and labyrinth disorders

Deafness neurosensory

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Ear and labyrinth disorders

Deafness unilateral

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Ear and labyrinth disorders

Hypoacusis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Ear and labyrinth disorders

Otolithiasis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Ear and labyrinth disorders

Sudden hearing loss

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Ear and labyrinth disorders

Tinnitus

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Ear and labyrinth disorders

Vertigo

0.18%

12/6532 • Number of events 13 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.17%

11/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Ear and labyrinth disorders

Vertigo positional

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Ear and labyrinth disorders

Vestibular disorder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Endocrine disorders

Acromegaly

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Endocrine disorders

Adrenal mass

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Endocrine disorders

Goitre

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.12%

8/6535 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Endocrine disorders

Hyperparathyroidism primary

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Endocrine disorders

Hyperthyroidism

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Endocrine disorders

Hypothyroidism

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Endocrine disorders

Parathyroid disorder

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Endocrine disorders

Thyroid mass

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Cataract

0.44%

29/6532 • Number of events 35 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.31%

20/6535 • Number of events 24 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Conjunctival erosion

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Conjunctivochalasis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Corneal erosion

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Dacryostenosis acquired

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Diabetic retinopathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Diplopia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Exophthalmos

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Eyelid ptosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Glaucoma

0.06%

4/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Iridocyclitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Macular hole

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Maculopathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Open angle glaucoma

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Optic ischaemic neuropathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Retinal artery embolism

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Retinal artery occlusion

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Retinal detachment

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Retinal haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Retinal tear

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Retinal vein occlusion

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Retinopathy

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Rhegmatogenous retinal detachment

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Tractional retinal detachment

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Vitreous detachment

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Vitreous disorder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Eye disorders

Vitreous haemorrhage

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Abdominal adhesions

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Abdominal discomfort

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Abdominal distension

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Abdominal hernia

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Abdominal hernia obstructive

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Abdominal incarcerated hernia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Abdominal pain

0.12%

8/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Abdominal pain lower

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Abdominal pain upper

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Abdominal wall haematoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Alcoholic pancreatitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Anal fistula

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Anal haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Anal stenosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Anogenital dysplasia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Ascites

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Barrett's oesophagus

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Chronic gastritis

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Coeliac artery stenosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Colitis

0.11%

7/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Colitis ischaemic

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Colitis ulcerative

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Colonic fistula

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Constipation

0.09%

6/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Crohn's disease

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Dental cyst

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Diabetic gastroparesis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Diabetic gastropathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Diaphragmatic hernia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Diarrhoea

0.32%

21/6532 • Number of events 21 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.15%

10/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Dieulafoy's vascular malformation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Diverticular perforation

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Diverticulum

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Diverticulum intestinal

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Diverticulum intestinal haemorrhagic

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Duodenal perforation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Duodenal polyp

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Duodenal ulcer

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Duodenal ulcer haemorrhage

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Duodenal ulcer perforation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Duodenitis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Duodenogastric reflux

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Dysbiosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Dyspepsia

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Dysphagia

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Enteritis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Enterocolitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Enterovesical fistula

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Erosive duodenitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Faecaloma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Functional gastrointestinal disorder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastric disorder

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastric haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastric polyps

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastric ulcer

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastric ulcer haemorrhage

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastric ulcer perforation

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastritis

0.14%

9/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.12%

8/6535 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastritis erosive

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastritis haemorrhagic

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastroduodenal ulcer

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastrointestinal disorder

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastrointestinal erosion

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastrointestinal haemorrhage

0.37%

24/6532 • Number of events 31 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.15%

10/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastrointestinal inflammation

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastrointestinal pain

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastrointestinal polyp haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastrointestinal ulcer haemorrhage

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastrointestinal vascular malformation haemorrhagic

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gastrooesophageal reflux disease

0.11%

7/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Gingival bleeding

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Haematemesis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Haematochezia

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Haemorrhagic erosive gastritis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Haemorrhoidal haemorrhage

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Haemorrhoids

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Haemorrhoids thrombosed

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Hiatus hernia

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Ileus

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Ileus paralytic

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Incarcerated inguinal hernia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Inguinal hernia

0.28%

18/6532 • Number of events 19 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.17%

11/6535 • Number of events 12 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Intestinal haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Intestinal ischaemia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Intestinal mass

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Intestinal obstruction

0.11%

7/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Intestinal perforation

0.03%

2/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Intestinal polyp

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Intestinal pseudo-obstruction

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Intra-abdominal haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Irritable bowel syndrome

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Large intestinal obstruction

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Large intestinal stenosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Large intestine perforation

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Large intestine polyp

0.21%

14/6532 • Number of events 15 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.20%

13/6535 • Number of events 19 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Lower gastrointestinal haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Mechanical ileus

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Melaena

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Mesenteric artery stenosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Mesenteric haemorrhage

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Mesenteric vascular insufficiency

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Mouth haemorrhage

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Nausea

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Noninfective sialoadenitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Obstructive pancreatitis

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Oedematous pancreatitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Oesophageal achalasia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Oesophageal spasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Oesophageal stenosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Oesophageal varices haemorrhage

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Oesophagitis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Pancreatic disorder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Pancreatitis

0.17%

11/6532 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.15%

10/6535 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Pancreatitis acute

0.18%

12/6532 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.17%

11/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Pancreatitis chronic

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Peptic ulcer

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Peptic ulcer haemorrhage

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Pharyngo-oesophageal diverticulum

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Pneumatosis intestinalis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Rectal haemorrhage

0.11%

7/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Rectal polyp

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Rectal prolapse

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Reflux gastritis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Retroperitoneal fibrosis

0.02%

1/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Retroperitoneal haematoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Retroperitoneal haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Retroperitoneal mass

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Small intestinal obstruction

0.08%

5/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 12 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Thrombosis mesenteric vessel

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Tongue cyst

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Umbilical hernia

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Upper gastrointestinal haemorrhage

0.18%

12/6532 • Number of events 12 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Volvulus

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Volvulus of small bowel

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Gastrointestinal disorders

Vomiting

0.12%

8/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Adverse drug reaction

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Adverse event

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Asthenia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Cardiac death

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Catheter site haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Chest discomfort

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Chest pain

0.15%

10/6532 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.35%

23/6535 • Number of events 23 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Complication associated with device

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Cyst

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Death

0.87%

57/6532 • Number of events 57 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.58%

38/6535 • Number of events 38 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Decreased activity

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Device related thrombosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Drowning

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Drug intolerance

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Exercise tolerance decreased

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Fatigue

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Gait disturbance

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

General physical health deterioration

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Generalised oedema

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Hernia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Impaired healing

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Implant site haematoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Implant site inflammation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Inflammation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Injection site phlebitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Malaise

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Medical device site haematoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Mucosal inflammation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Multi-organ disorder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Multiple organ dysfunction syndrome

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

No adverse event

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Nodule

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Non-cardiac chest pain

0.78%

51/6532 • Number of events 69 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.78%

51/6535 • Number of events 53 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Oedema peripheral

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Organ failure

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Pelvic mass

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Perforation

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Peripheral swelling

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Pyrexia

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Retention cyst

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Stent-graft endoleak

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Sudden cardiac death

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Sudden death

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Surgical failure

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Systemic inflammatory response syndrome

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Ulcer haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Unevaluable event

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Vascular stent occlusion

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Vascular stent stenosis

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

General disorders

Vascular stent thrombosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Bile duct stenosis

0.02%

1/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Bile duct stone

0.06%

4/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Biliary colic

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Biliary tract disorder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Cholangitis

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Cholangitis acute

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Cholecystitis

0.20%

13/6532 • Number of events 13 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.26%

17/6535 • Number of events 18 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Cholecystitis acute

0.31%

20/6532 • Number of events 20 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.18%

12/6535 • Number of events 13 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Cholecystitis chronic

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Cholelithiasis

0.41%

27/6532 • Number of events 28 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.23%

15/6535 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Chronic hepatitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Hepatic cirrhosis

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Hepatic failure

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Hepatic steatosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Hepatitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Hyperbilirubinaemia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Ischaemic hepatitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Jaundice

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Jaundice cholestatic

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Liver disorder

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Non-alcoholic steatohepatitis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Nonalcoholic fatty liver disease

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Portal vein thrombosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Hepatobiliary disorders

Post cholecystectomy syndrome

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Immune system disorders

Anaphylactic reaction

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Immune system disorders

Anaphylactic shock

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Immune system disorders

Contrast media allergy

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Immune system disorders

Drug hypersensitivity

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Immune system disorders

Heart transplant rejection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Immune system disorders

Hypersensitivity

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Immune system disorders

Kidney transplant rejection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Immune system disorders

Sarcoidosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Abdominal abscess

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Abdominal wall abscess

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Abdominal wall infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Abscess

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Abscess limb

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Acarodermatitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Acquired immunodeficiency syndrome

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Acute hepatitis b

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Acute sinusitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Adenovirus infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Anal abscess

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Appendicitis

0.14%

9/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.21%

14/6535 • Number of events 14 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Appendicitis perforated

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Arthritis bacterial

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Arthritis infective

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Atypical pneumonia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Bacteraemia

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Bacterial colitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Bacterial infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Bacterial prostatitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Beta haemolytic streptococcal infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Biliary sepsis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Borrelia infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Breast abscess

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Bronchitis

0.15%

10/6532 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.35%

23/6535 • Number of events 23 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Bronchitis viral

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Bursitis infective

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Campylobacter colitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Campylobacter gastroenteritis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Candida pneumonia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Carbuncle

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Cellulitis

0.60%

39/6532 • Number of events 46 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.70%

46/6535 • Number of events 52 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Cellulitis of male external genital organ

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Cellulitis staphylococcal

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Chest wall abscess

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Cholangitis infective

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Cholecystitis infective

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Chronic sinusitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Clostridium difficile colitis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Clostridium difficile infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Cystitis

0.06%

4/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Dermatitis infected

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Device related infection

0.03%

2/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Diabetic foot infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Diabetic gangrene

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Diarrhoea infectious

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Diverticulitis

0.20%

13/6532 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 12 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Diverticulitis intestinal haemorrhagic

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Dysentery

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Emphysematous pyelonephritis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Empyema

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Endocarditis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Endocarditis bacterial

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Enterococcal sepsis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Epidemic pleurodynia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Epididymitis

0.02%

1/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Erysipelas

0.09%

6/6532 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Escherichia bacteraemia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Escherichia infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Escherichia pyelonephritis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Escherichia sepsis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Escherichia urinary tract infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

External ear cellulitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Extradural abscess

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Folliculitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Fournier's gangrene

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Fungal infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Gallbladder abscess

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Gallbladder empyema

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Gangrene

0.11%

7/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Gastroenteritis

0.23%

15/6532 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.31%

20/6535 • Number of events 20 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Gastroenteritis clostridial

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Gastroenteritis viral

0.06%

4/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Gastrointestinal infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Gastrointestinal viral infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Genitourinary tract infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Graft infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Groin abscess

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Hiv infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Haematoma infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Helicobacter gastritis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Hepatic cyst infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Hepatitis c

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Herpes zoster

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Implant site infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Incision site cellulitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Infected cyst

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Infected dermal cyst

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Infected skin ulcer

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Infectious pleural effusion

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Infective aneurysm

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Infective exacerbation of chronic obstructive airways disease

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Infective tenosynovitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Influenza

0.18%

12/6532 • Number of events 13 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.23%

15/6535 • Number of events 15 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Intervertebral discitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Intestinal gangrene

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Kidney infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Klebsiella infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Large intestine infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Laryngitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Liver abscess

0.05%

3/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Localised infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Lower respiratory tract infection

0.12%

8/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.18%

12/6535 • Number of events 13 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Lower respiratory tract infection bacterial

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Lyme disease

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Lymphangitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Mastitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Mediastinitis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Medical device site abscess

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Medical device site infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Medical device site joint infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Meningitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Meningitis bacterial

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Meningoencephalitis herpetic

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Moraxella infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Mycetoma mycotic

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Nasopharyngitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Necrotising fasciitis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Oesophageal candidiasis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Orchitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Osteomyelitis

0.14%

9/6532 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.18%

12/6535 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Osteomyelitis acute

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Osteomyelitis chronic

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Otitis externa

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Otitis media

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Otitis media acute

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Otitis media bacterial

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Otitis media chronic

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Parainfluenzae virus infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Parotitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pelvic infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Perineal abscess

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Periodontitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Perirectal abscess

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Peritonitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Peritonsillitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pilonidal cyst

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pneumonia

1.7%

113/6532 • Number of events 130 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

1.9%

126/6535 • Number of events 135 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pneumonia bacterial

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pneumonia haemophilus

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pneumonia legionella

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pneumonia pseudomonal

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pneumonia staphylococcal

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pneumonia streptococcal

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pneumonia viral

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Post procedural cellulitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Post procedural sepsis

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Postoperative abscess

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Postoperative wound infection

0.12%

8/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pseudomonas infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Psoas abscess

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pulmonary nocardiosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pulmonary sepsis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pyelonephritis

0.14%

9/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.18%

12/6535 • Number of events 12 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pyelonephritis acute

0.11%

7/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Pyelonephritis chronic

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Rectal abscess

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Renal abscess

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Renal cyst infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Respiratory tract infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Respiratory tract infection viral

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Rotavirus infection

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Salmonellosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Scrotal abscess

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Sepsis

0.75%

49/6532 • Number of events 51 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.66%

43/6535 • Number of events 47 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Septic necrosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Septic shock

0.12%

8/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Sinobronchitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Sinusitis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Skin infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Staphylococcal abscess

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Staphylococcal bacteraemia

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Staphylococcal infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Staphylococcal sepsis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Streptococcal abscess

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Streptococcal sepsis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Subcutaneous abscess

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Tonsillitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Tooth abscess

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Tracheitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Tracheobronchitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Upper respiratory tract infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Urinary tract infection

0.37%

24/6532 • Number of events 26 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.55%

36/6535 • Number of events 40 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Urosepsis

0.14%

9/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Vestibular neuronitis

0.05%

3/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Viral infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Wound infection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Wound infection bacterial

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Infections and infestations

Wound sepsis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Abdominal injury

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Accidental overdose

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Acetabulum fracture

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Airway complication of anaesthesia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Alcohol poisoning

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Animal bite

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Ankle fracture

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Arterial bypass occlusion

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Arterial bypass stenosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Back injury

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Bone contusion

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Brain contusion

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Burns second degree

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Carbon monoxide poisoning

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Carotid artery restenosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Cervical vertebral fracture

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Chest injury

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Clavicle fracture

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Concussion

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Contusion

0.02%

1/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Coronary artery restenosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Craniocerebral injury

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Cystitis radiation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Epicondylitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Eyelid injury

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Facial bones fracture

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Fall

0.23%

15/6532 • Number of events 19 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.15%

10/6535 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Femoral neck fracture

0.14%

9/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Femur fracture

0.12%

8/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Fibula fracture

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Foot fracture

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Forearm fracture

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Foreign body aspiration

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Foreign body in gastrointestinal tract

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Fracture displacement

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Frostbite

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Hand fracture

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Head injury

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.12%

8/6535 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Hip fracture

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.17%

11/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Humerus fracture

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Hyphaema

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Incisional hernia

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Inflammation of wound

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Injury

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Intentional overdose

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Joint dislocation

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Joint injury

0.02%

1/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Ligament rupture

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Ligament sprain

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Limb injury

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Limb traumatic amputation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Lower limb fracture

0.05%

3/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Lumbar vertebral fracture

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Mallet finger

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Meniscus injury

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Multiple fractures

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Multiple injuries

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Muscle injury

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Muscle rupture

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Muscle strain

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Neck injury

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Overdose

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Patella fracture

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Pelvic organ injury

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Peripheral artery restenosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Peripheral nerve injury

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Periprosthetic fracture

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Pharyngeal contusion

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Poisoning

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Post concussion syndrome

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Post laminectomy syndrome

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Post procedural complication

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Post procedural fever

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Post procedural haematoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Post procedural haematuria

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Post procedural haemorrhage

0.11%

7/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Post procedural swelling

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Postoperative delirium

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Postoperative hypotension

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Postoperative ileus

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Postoperative respiratory failure

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Postoperative thoracic procedure complication

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Procedural haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Procedural hypotension

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Procedural nausea

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Procedural pain

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Pseudomeningocele

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Pubis fracture

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Pulmonary contusion

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Radiation dysphagia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Radiation injury

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Radius fracture

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Rib fracture

0.11%

7/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Road traffic accident

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Scapula fracture

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Shunt thrombosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Skeletal injury

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Skin abrasion

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Skin laceration

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Skull fracture

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Skull fractured base

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Soft tissue injury

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Spinal compression fracture

0.14%

9/6532 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Spinal cord injury

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Spinal fracture

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Splenic injury

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Splenic rupture

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Stress fracture

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Subcutaneous haematoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Subdural haematoma

0.17%

11/6532 • Number of events 14 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Subdural haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Suture related complication

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Tendon injury

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Tendon rupture

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Thermal burn

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Thoracic vertebral fracture

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Tibia fracture

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Toxicity to various agents

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Traumatic arthrosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Traumatic haematoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Traumatic haemothorax

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Traumatic ulcer

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Ulna fracture

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Upper limb fracture

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Urethral injury

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Vascular graft occlusion

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Vascular procedure complication

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Vascular pseudoaneurysm

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Wound

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Injury, poisoning and procedural complications

Wrist fracture

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Activated partial thromboplastin time prolonged

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Alanine aminotransferase increased

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Anticoagulation drug level above therapeutic

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Anticoagulation drug level increased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Aspartate aminotransferase increased

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Blood calcium decreased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Blood creatinine increased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Blood glucose abnormal

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Blood glucose decreased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Blood glucose fluctuation

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Blood glucose increased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Blood lactic acid increased

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Blood pressure increased

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

C-reactive protein increased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Ejection fraction decreased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Electrocardiogram change

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Gamma-glutamyltransferase increased

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Glycosylated haemoglobin increased

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Haemoglobin decreased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Heart rate irregular

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Hepatic enzyme increased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

International normalised ratio increased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Intraocular pressure increased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Liver function test abnormal

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Liver function test increased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Platelet count decreased

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Prostatic specific antigen increased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Sinus rhythm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Transaminases increased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Transplant evaluation

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Trial of void

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Troponin i increased

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Troponin increased

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Weight decreased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Investigations

Weight increased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Cardiometabolic syndrome

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Central obesity

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Decreased appetite

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Dehydration

0.12%

8/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.18%

12/6535 • Number of events 13 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Diabetes mellitus

0.66%

43/6532 • Number of events 47 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.75%

49/6535 • Number of events 50 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Diabetes mellitus inadequate control

0.40%

26/6532 • Number of events 29 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.37%

24/6535 • Number of events 32 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Diabetic complication

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Diabetic ketoacidosis

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Diabetic ketosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Diabetic metabolic decompensation

0.24%

16/6532 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.20%

13/6535 • Number of events 14 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Electrolyte imbalance

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Failure to thrive

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Fluid overload

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Gout

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Hypercalcaemia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Hyperglycaemia

0.20%

13/6532 • Number of events 13 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.18%

12/6535 • Number of events 14 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Hyperglycaemic hyperosmolar nonketotic syndrome

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Hyperhomocysteinaemia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Hyperkalaemia

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.20%

13/6535 • Number of events 13 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Hypertriglyceridaemia

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Hypervolaemia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Hypocalcaemia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Hypoglycaemia

0.21%

14/6532 • Number of events 15 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.24%

16/6535 • Number of events 18 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Hypokalaemia

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Hypomagnesaemia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Hyponatraemia

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Hypovolaemia

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Ketoacidosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Lactic acidosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Malnutrition

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Metabolic acidosis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Obesity

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.15%

10/6535 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Type 2 diabetes mellitus

0.43%

28/6532 • Number of events 32 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.28%

18/6535 • Number of events 19 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Metabolism and nutrition disorders

Vitamin b12 deficiency

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Arthralgia

0.15%

10/6532 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.18%

12/6535 • Number of events 14 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Arthritis

0.12%

8/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Arthropathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Back pain

0.12%

8/6532 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.17%

11/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Bone lesion

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Bursitis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Cervical spinal stenosis

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Chondrocalcinosis pyrophosphate

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Compartment syndrome

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Costochondritis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Crystal arthropathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Fibromyalgia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Flank pain

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Foot deformity

0.06%

4/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Fracture nonunion

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Gouty arthritis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Groin pain

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Haematoma muscle

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Inguinal mass

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Intervertebral disc degeneration

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Intervertebral disc disorder

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Intervertebral disc displacement

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Intervertebral disc protrusion

0.20%

13/6532 • Number of events 13 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.26%

17/6535 • Number of events 17 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Joint ankylosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Joint effusion

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Limb deformity

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Limb discomfort

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Limb mass

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Lumbar spinal stenosis

0.28%

18/6532 • Number of events 18 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.17%

11/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Mandibular mass

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Meniscal degeneration

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Mobility decreased

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Muscle spasms

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Muscular weakness

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain

0.11%

7/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Musculoskeletal pain

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Myalgia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Myopathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Neck pain

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Neuropathic arthropathy

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Osteitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Osteoarthritis

1.0%

66/6532 • Number of events 69 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.89%

58/6535 • Number of events 67 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Osteochondrosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Osteonecrosis

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Osteonecrosis of jaw

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Osteoporosis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Pain in extremity

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Periarthritis

0.02%

1/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Polymyalgia rheumatica

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Psoriatic arthropathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Rhabdomyolysis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Rheumatic disorder

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Rheumatoid arthritis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Rotator cuff syndrome

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.15%

10/6535 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Spinal instability

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Spinal osteoarthritis

0.26%

17/6532 • Number of events 17 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.12%

8/6535 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Spinal pain

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Spinal stenosis

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.17%

11/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Spondylolisthesis

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Spondylolysis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Synovial cyst

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Tendon disorder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Tendonitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Tenosynovitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Thoracic spinal stenosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Musculoskeletal and connective tissue disorders

Vertebral foraminal stenosis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Acoustic neuroma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Acute lymphocytic leukaemia

0.02%

1/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Acute myeloid leukaemia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Acute promyelocytic leukaemia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma gastric

0.05%

3/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma of colon

0.06%

4/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma pancreas

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adrenal adenoma

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Anal cancer

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Angiomyolipoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Anogenital warts

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

B-cell prolymphocytic leukaemia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

B-cell small lymphocytic lymphoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Basal cell carcinoma

0.23%

15/6532 • Number of events 15 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.26%

17/6535 • Number of events 22 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign bone neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign neoplasm

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign neoplasm of adrenal gland

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign neoplasm of bladder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign neoplasm of eyelid

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign neoplasm of thyroid gland

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign ovarian tumour

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign pancreatic neoplasm

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bile duct cancer

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder cancer

0.14%

9/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder cancer recurrent

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder cancer stage i, with cancer in situ

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder neoplasm

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder squamous cell carcinoma stage unspecified

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder transitional cell carcinoma

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder transitional cell carcinoma recurrent

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bone cancer

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bowen's disease

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Brain cancer metastatic

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Brain neoplasm malignant

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer

0.12%

8/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.26%

17/6535 • Number of events 17 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer female

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer metastatic

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer stage i

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer stage ii

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bronchial carcinoma

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bronchioloalveolar carcinoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Carcinoid tumour pulmonary

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cardiac neoplasm malignant

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Castleman's disease

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cervix carcinoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cholangiocarcinoma

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chronic lymphocytic leukaemia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chronic myeloid leukaemia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Clear cell renal cell carcinoma

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon adenoma

0.05%

3/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer

0.15%

10/6532 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.31%

20/6535 • Number of events 21 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer metastatic

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer stage 0

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer stage iv

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon neoplasm

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colorectal adenocarcinoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colorectal cancer

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colorectal cancer metastatic

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Craniopharyngioma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Diffuse large b-cell lymphoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ear neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Endometrial adenocarcinoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Endometrial cancer

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Essential thrombocythaemia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Female reproductive neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gallbladder cancer

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastric adenoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastric cancer

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastrointestinal carcinoma

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastrointestinal stromal tumour

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Glioblastoma multiforme

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Haemangioma of bone

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Head and neck cancer metastatic

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatic cancer

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatic neoplasm

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatocellular carcinoma

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Immune reconstitution inflammatory syndrome associated kaposi's sarcoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intestinal adenocarcinoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intraductal papillary mucinous neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intraductal papilloma of breast

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intraductal proliferative breast lesion

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Invasive breast carcinoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Invasive ductal breast carcinoma

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Keratinising squamous cell carcinoma of nasopharynx

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Large intestine benign neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Laryngeal cancer

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Laryngeal neoplasm

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Laryngeal squamous cell carcinoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lentigo maligna

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Leukaemia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lipoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung adenocarcinoma

0.11%

7/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung adenocarcinoma recurrent

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung cancer metastatic

0.05%

3/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung carcinoma cell type unspecified stage ii

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung carcinoma cell type unspecified stage iv

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm malignant

0.12%

8/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.18%

12/6535 • Number of events 12 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lymphoma

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant melanoma

0.17%

11/6532 • Number of events 12 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant melanoma stage iv

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant neoplasm of eye

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant neoplasm of renal pelvis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant neoplasm of spinal cord

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant pleural effusion

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant polyp

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Mantle cell lymphoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Meningioma

0.03%

2/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Meningioma benign

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to bone

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to central nervous system

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to liver

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to lung

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to lymph nodes

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to peritoneum

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to pleura

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to rectum

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to soft tissue

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastasis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic gastric cancer

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic malignant melanoma

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic neoplasm

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic squamous cell carcinoma

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic uterine cancer

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Mucoepidermoid carcinoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Myelodysplastic syndrome

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Myelofibrosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm malignant

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm of appendix

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm prostate

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm skin

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neuroendocrine carcinoma

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neuroendocrine carcinoma metastatic

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neuroendocrine carcinoma of the skin

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neuroendocrine tumour

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Nodular melanoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-hodgkin's lymphoma

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-hodgkin's lymphoma stage i

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-small cell lung cancer

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-small cell lung cancer metastatic

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-small cell lung cancer stage iiia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-small cell lung cancer stage iv

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal adenocarcinoma

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal cancer metastatic

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal carcinoma

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal papilloma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal squamous cell carcinoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oral neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oropharyngeal cancer

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oropharyngeal squamous cell carcinoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ovarian adenoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ovarian cancer

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ovarian endometrioid carcinoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ovarian granulosa cell tumour

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Paget's disease of the vulva

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma

0.18%

12/6532 • Number of events 12 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma metastatic

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma stage iv

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Papillary renal cell carcinoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Papillary thyroid cancer

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Parathyroid tumour benign

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pituitary tumour benign

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Plasma cell myeloma

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Plasmacytoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer

0.52%

34/6532 • Number of events 34 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.50%

33/6535 • Number of events 34 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer metastatic

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer recurrent

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer stage iv

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostatic adenoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Queyrat erythroplasia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal adenocarcinoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal cancer

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal cancer metastatic

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal cancer stage iv

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectosigmoid cancer

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cancer

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cancer metastatic

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cancer stage i

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cell carcinoma

0.09%

6/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cell carcinoma stage iv

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Retroperitoneal neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Salivary gland adenoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Salivary gland neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Schwannoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Secretory adenoma of pituitary

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Sinonasal papilloma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Skin cancer

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small cell lung cancer

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small cell lung cancer metastatic

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small intestine carcinoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Soft tissue neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Spindle cell sarcoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma

0.05%

3/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of lung

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of skin

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.12%

8/6535 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of the oral cavity

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of the tongue

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Superficial spreading melanoma stage unspecified

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

T-cell lymphoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Thyroid adenoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Thyroid cancer

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Thyroid cancer metastatic

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tongue neoplasm

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tongue neoplasm malignant stage unspecified

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Transitional cell carcinoma

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ureteric cancer

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Urinary tract neoplasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Uterine cancer

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Uterine leiomyoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Vaginal adenocarcinoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Altered state of consciousness

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Amnesia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Amyotrophic lateral sclerosis

0.02%

1/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Aphasia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Autonomic nervous system imbalance

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Balance disorder

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Basal ganglia infarction

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Basilar artery aneurysm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Basilar artery stenosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Brain stem ischaemia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Brain stem stroke

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Carotid arteriosclerosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Carotid artery disease

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Carotid artery occlusion

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Carotid artery stenosis

0.26%

17/6532 • Number of events 18 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.21%

14/6535 • Number of events 15 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Carpal tunnel syndrome

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cerebellar infarction

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cerebellar stroke

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cerebral artery stenosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cerebral haematoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cerebral haemorrhage

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cerebral infarction

0.18%

12/6532 • Number of events 12 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.26%

17/6535 • Number of events 18 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cerebral ischaemia

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.18%

12/6535 • Number of events 15 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cerebral small vessel ischaemic disease

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cerebral venous sinus thrombosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cerebrovascular accident

0.69%

45/6532 • Number of events 46 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.64%

42/6535 • Number of events 43 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cerebrovascular insufficiency

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cerebrovascular stenosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cervical radiculopathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cervicobrachial syndrome

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cluster headache

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Cognitive disorder

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Dementia

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Dementia alzheimer's type

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Demyelination

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Diabetic autonomic neuropathy

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Diabetic coma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Diabetic neuropathy

0.09%

6/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Dizziness

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Dizziness postural

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Embolic stroke

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Encephalopathy

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Epilepsy

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Essential tremor

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Facial paralysis

0.15%

10/6532 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Facial paresis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Generalised tonic-clonic seizure

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Haemorrhage intracranial

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Haemorrhagic stroke

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Haemorrhagic transformation stroke

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Headache

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Hemiparesis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Hepatic encephalopathy

0.02%

1/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Hypertensive encephalopathy

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Hypoaesthesia

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Hypotonia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Iiird nerve paralysis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Intracranial aneurysm

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Intracranial mass

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Ischaemic cerebral infarction

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Ischaemic stroke

0.46%

30/6532 • Number of events 33 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.37%

24/6535 • Number of events 24 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Lacunar infarction

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Lacunar stroke

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Loss of consciousness

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Lumbar radiculopathy

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Lumbosacral plexus lesion

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Lumbosacral radiculopathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Memory impairment

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Mental impairment

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Metabolic encephalopathy

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Migraine

0.03%

2/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Monoplegia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Motor neurone disease

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Multiple sclerosis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Multiple sclerosis relapse

0.03%

2/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Myasthenia gravis

0.03%

2/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Myelopathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Myoclonus

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Nerve compression

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Nervous system disorder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Neuralgia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Neurological symptom

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Neuropathy peripheral

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Normal pressure hydrocephalus

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Paraesthesia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Paraparesis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Paraplegia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Parkinson's disease

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Parkinsonism

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Polyneuropathy

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Posterior reversible encephalopathy syndrome

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Presyncope

0.12%

8/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Radial nerve palsy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Radicular pain

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Radiculopathy

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Sciatica

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Seizure

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Somnolence

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Spinal cord compression

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Spinal cord haematoma

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Spinal cord herniation

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Spinal cord infarction

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Spinal cord ischaemia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Spinal vascular disorder

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Spondylitic myelopathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Subarachnoid haemorrhage

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Syncope

0.49%

32/6532 • Number of events 33 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.23%

15/6535 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Thalamic infarction

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Transient aphasia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Transient global amnesia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Transient ischaemic attack

0.63%

41/6532 • Number of events 46 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.63%

41/6535 • Number of events 45 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Tremor

0.02%

1/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Vascular dementia

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Vascular encephalopathy

0.14%

9/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Vascular headache

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Vertebrobasilar insufficiency

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Vertebrobasilar stroke

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Nervous system disorders

Vocal cord paralysis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Product Issues

Device dislocation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Product Issues

Device failure

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Product Issues

Device lead damage

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Product Issues

Device malfunction

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Product Issues

Device occlusion

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Product Issues

Device power source issue

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Product Issues

Thrombosis in device

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Acute psychosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Anxiety

0.03%

2/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Anxiety disorder

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Bipolar disorder

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Borderline personality disorder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Completed suicide

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Confusional state

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Conversion disorder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Delirium

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Depressed mood

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Depression

0.15%

10/6532 • Number of events 14 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Depression suicidal

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Insomnia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Major depression

0.09%

6/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Mania

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Mental disorder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Mental status changes

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Mood disorder due to a general medical condition

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Organic brain syndrome

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Post-traumatic stress disorder

0.02%

1/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Psychotic disorder

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Schizophrenia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Stress

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Psychiatric disorders

Suicidal ideation

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Acute kidney injury

0.70%

46/6532 • Number of events 54 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.81%

53/6535 • Number of events 59 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Azotaemia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Bladder mass

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Bladder outlet obstruction

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Bladder prolapse

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Calculus bladder

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Calculus urinary

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Chronic kidney disease

0.23%

15/6532 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Cystitis haemorrhagic

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Diabetic nephropathy

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Dysuria

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

End stage renal disease

0.06%

4/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Genitourinary symptom

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Haematuria

0.12%

8/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.09%

6/6535 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Hydronephrosis

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Hypertensive nephropathy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Hypertonic bladder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Ketonuria

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Lower urinary tract symptoms

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Nephrolithiasis

0.23%

15/6532 • Number of events 18 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.31%

20/6535 • Number of events 24 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Nephropathy

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Nephrotic syndrome

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Renal artery arteriosclerosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Renal artery stenosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Renal artery thrombosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Renal colic

0.05%

3/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Renal cyst

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Renal embolism

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Renal failure

0.26%

17/6532 • Number of events 18 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.24%

16/6535 • Number of events 17 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Renal haematoma

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Renal haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Renal impairment

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Renal injury

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Renal ischaemia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Renal mass

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Stag horn calculus

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Stress urinary incontinence

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Tubulointerstitial nephritis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Ureteric stenosis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Ureterolithiasis

0.12%

8/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.12%

8/6535 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Urethral haemorrhage

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Urethral stenosis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Urinary bladder haemorrhage

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Urinary fistula

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Urinary incontinence

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Renal and urinary disorders

Urinary retention

0.09%

6/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Acquired hydrocele

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Adenomyosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Adnexal torsion

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Balanoposthitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Benign prostatic hyperplasia

0.17%

11/6532 • Number of events 13 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.28%

18/6535 • Number of events 18 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Breast discharge

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Breast disorder

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Breast hyperplasia

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Breast mass

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Breast pain

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Endometrial hyperplasia

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Endometrial thickening

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Endometriosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Epididymal cyst

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Female genital tract fistula

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Genital leukoplakia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Haemorrhagic ovarian cyst

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Ovarian cyst

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Pelvic congestion

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Pelvic fluid collection

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Pelvic prolapse

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Perineal cyst

0.02%

1/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Peyronie's disease

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Postmenopausal haemorrhage

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Prostatic disorder

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Prostatitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Prostatomegaly

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Seminal vesiculitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Spermatocele

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Testicular cyst

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Testicular mass

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Uterine polyp

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Uterine prolapse

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Vaginal fistula

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Vaginal haemorrhage

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Reproductive system and breast disorders

Vaginal prolapse

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Acute pulmonary oedema

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Acute respiratory distress syndrome

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure

0.35%

23/6532 • Number of events 29 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.23%

15/6535 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Asphyxia

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Aspiration

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Asthma

0.12%

8/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.17%

11/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Atelectasis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Bronchial hyperreactivity

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Bronchiectasis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Bronchitis chronic

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Bronchospasm

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease

0.47%

31/6532 • Number of events 35 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.58%

38/6535 • Number of events 42 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Chronic respiratory failure

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Chylothorax

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Cough

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Dysphonia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Dyspnoea

0.17%

11/6532 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.23%

15/6535 • Number of events 17 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Dyspnoea exertional

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Emphysema

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Epiglottic cyst

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Epistaxis

0.20%

13/6532 • Number of events 13 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Haemoptysis

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Haemothorax

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Hypercapnia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Hypersensitivity pneumonitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Hypoxia

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Interstitial lung disease

0.03%

2/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Laryngeal oedema

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Laryngospasm

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Nasal congestion

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Nasal septum deviation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Organising pneumonia

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pharyngeal stenosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pickwickian syndrome

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pleural effusion

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pleuritic pain

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pneumonia aspiration

0.09%

6/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pneumonitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pneumothorax

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pneumothorax spontaneous

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pulmonary arterial hypertension

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pulmonary congestion

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism

0.35%

23/6532 • Number of events 23 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.31%

20/6535 • Number of events 20 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pulmonary haemorrhage

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pulmonary hypertension

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pulmonary infarction

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pulmonary mass

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Pulmonary oedema

0.11%

7/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Respiratory arrest

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Respiratory distress

0.03%

2/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Respiratory failure

0.09%

6/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.18%

12/6535 • Number of events 17 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Sleep apnoea syndrome

0.11%

7/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.11%

7/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Tonsillar disorder

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Respiratory, thoracic and mediastinal disorders

Vocal cord polyp

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Acanthosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Alopecia scarring

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Angioedema

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Decubitus ulcer

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Dermal cyst

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Dermatitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Dermatitis allergic

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Dermatitis contact

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Dermatomyositis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Diabetic foot

0.09%

6/6532 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.21%

14/6535 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Eczema

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Erythema multiforme

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Granuloma annulare

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Henoch-schonlein purpura

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Hidradenitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Hypersensitivity vasculitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Ischaemic skin ulcer

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Panniculitis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Pruritus

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Skin necrosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Skin ulcer

0.12%

8/6532 • Number of events 9 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.18%

12/6535 • Number of events 14 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Skin and subcutaneous tissue disorders

Urticaria

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Social circumstances

Aborted pregnancy

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Surgical and medical procedures

Hospitalisation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Accelerated hypertension

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Aneurysm

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Aortic aneurysm

0.24%

16/6532 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.17%

11/6535 • Number of events 12 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Aortic aneurysm rupture

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Aortic dissection

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Aortic embolus

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Aortic stenosis

0.12%

8/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Arterial occlusive disease

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Arterial stenosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Arteriosclerosis

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Blood pressure inadequately controlled

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Circulatory collapse

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Deep vein thrombosis

0.21%

14/6532 • Number of events 15 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.23%

15/6535 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Diabetic vascular disorder

0.03%

2/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Dry gangrene

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Embolism

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Embolism venous

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Essential hypertension

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Extremity necrosis

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.08%

5/6535 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Femoral artery perforation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Haematoma

0.08%

5/6532 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Haemodynamic instability

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Hypertension

0.46%

30/6532 • Number of events 33 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.47%

31/6535 • Number of events 35 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Hypertensive crisis

0.23%

15/6532 • Number of events 19 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.14%

9/6535 • Number of events 12 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Hypertensive emergency

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Hypertensive urgency

0.09%

6/6532 • Number of events 6 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Hypotension

0.17%

11/6532 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.15%

10/6535 • Number of events 12 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Hypovolaemic shock

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Iliac artery occlusion

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Iliac artery stenosis

0.05%

3/6532 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.03%

2/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Inferior vena cava perforation

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Intermittent claudication

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.06%

4/6535 • Number of events 7 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Jugular vein thrombosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Leriche syndrome

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Lymphoedema

0.03%

2/6532 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Malignant hypertension

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Neurogenic shock

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Orthostatic hypotension

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.15%

10/6535 • Number of events 11 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Peripheral arterial occlusive disease

0.46%

30/6532 • Number of events 39 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.69%

45/6535 • Number of events 52 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Peripheral artery aneurysm

0.05%

3/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Peripheral artery aneurysm rupture

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Peripheral artery occlusion

0.11%

7/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.12%

8/6535 • Number of events 10 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Peripheral artery stenosis

0.11%

7/6532 • Number of events 8 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 5 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Peripheral artery thrombosis

0.06%

4/6532 • Number of events 4 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 2 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Peripheral coldness

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Peripheral ischaemia

0.24%

16/6532 • Number of events 21 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.17%

11/6535 • Number of events 13 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Peripheral vascular disorder

0.20%

13/6532 • Number of events 20 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.18%

12/6535 • Number of events 16 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Peripheral venous disease

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Phlebitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Shock

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Subclavian artery stenosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Subclavian steal syndrome

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Subclavian vein thrombosis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Thrombophlebitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.05%

3/6535 • Number of events 3 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Thrombosis

0.00%

0/6532 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Vasculitis

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.02%

1/6535 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Vascular disorders

Venous thrombosis limb

0.02%

1/6532 • Number of events 1 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

0.00%

0/6535 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Measure	Epanova n=6532 participants at risk Omega-3 carboxylic acid 4 x 1 gram capsule	Placebo n=6535 participants at risk Corn oil 4 x 1 gram capsule
Gastrointestinal disorders Abdominal discomfort	1.3% 87/6532 • Number of events 102 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.	0.54% 35/6535 • Number of events 38 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.
Gastrointestinal disorders Abdominal pain	1.4% 90/6532 • Number of events 104 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.	0.83% 54/6535 • Number of events 61 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.
Gastrointestinal disorders Abdominal pain upper	1.2% 80/6532 • Number of events 99 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.	0.90% 59/6535 • Number of events 68 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.
Gastrointestinal disorders Diarrhoea	11.7% 765/6532 • Number of events 1049 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.	4.8% 316/6535 • Number of events 386 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.
Gastrointestinal disorders Dyspepsia	1.4% 89/6532 • Number of events 104 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.	0.63% 41/6535 • Number of events 53 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.
Gastrointestinal disorders Nausea	3.1% 204/6532 • Number of events 229 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.	1.7% 110/6535 • Number of events 126 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.
Infections and infestations Nasopharyngitis	1.5% 97/6532 • Number of events 193 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.	1.1% 75/6535 • Number of events 145 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.
Metabolism and nutrition disorders Diabetes mellitus	2.3% 147/6532 • Number of events 150 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.	1.9% 121/6535 • Number of events 122 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.
Metabolism and nutrition disorders Type 2 diabetes mellitus	2.0% 130/6532 • Number of events 131 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.	2.3% 153/6535 • Number of events 155 • Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.

Trial Outcomes & Findings for Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia (NCT NCT02104817)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

Adverse Events

Epanova

Placebo

Serious adverse events

Other adverse events

Additional Information

AstraZenenca Information Center

Results disclosure agreements