Trial Outcomes & Findings for A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men (NCT NCT03518034)

NCT ID: NCT03518034

Last Updated: 2024-03-13

Results Overview

MACE is a composite endpoint including non-fatal myocardial infraction (MI), non-fatal stroke and cardiovascular (CV) death as adjudicated by Clinical Events Committee (CEC).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 5246 participants
• Primary outcome timeframe: Randomization to event or last known date if no event (up to approximately 52 months)
• Results posted on: 2024-03-13

Participant Flow

Participants were recruited in the study across 316 sites in the US and Puerto Rico.

Of the 5246 participants randomized in the study, 42 participant identification numbers (IDs; AndroGel: 22 IDs; Placebo: 20 IDs) were randomized to 20 unique participants and these 42 duplicate/triplicate IDs were excluded from the Full Analysis Set. Additionally, a total of 6 randomized participants (AndroGel: 5 participants; Placebo: 1 participant) did not receive treatment and were excluded from the from the Safety Analysis Set, which resulted in 5198 participants in the Safety Analysis Set.

Participant milestones

Measure	AndroGel 1.62% Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug once daily (OD). Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo Participants received matching placebo OD.
Overall Study STARTED	2601	2603
Overall Study Participants in Safety Analysis Set (Randomized, Treated, no Duplicate/Triplicate Participant IDs)	2596	2602
Overall Study COMPLETED	1594	1581
Overall Study NOT COMPLETED	1007	1022

Reasons for withdrawal

Measure	AndroGel 1.62% Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug once daily (OD). Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo Participants received matching placebo OD.
Overall Study Not Treated	5	1
Overall Study Withdrawal by Subject	309	351
Overall Study Lost to Follow-up	446	458
Overall Study Adverse Event	138	130
Overall Study Lack of Efficacy	11	23
Overall Study COVID-19 Logistical Restriction	7	3
Overall Study Serum Testosterone Level >750 ng/dL	5	0
Overall Study Other, Not Specified	84	53
Overall Study Reason Missing	2	3

Baseline Characteristics

A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men

Baseline characteristics by cohort

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.	Total n=5198 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 7.93 • n=5 Participants	63.3 years STANDARD_DEVIATION 7.85 • n=7 Participants	63.3 years STANDARD_DEVIATION 7.89 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	2596 Participants n=5 Participants	2602 Participants n=7 Participants	5198 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	409 Participants n=5 Participants	439 Participants n=7 Participants	848 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2186 Participants n=5 Participants	2161 Participants n=7 Participants	4347 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) Asian	40 Participants n=5 Participants	47 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) Black or African American	445 Participants n=5 Participants	432 Participants n=7 Participants	877 Participants n=5 Participants
Race (NIH/OMB) White	2066 Participants n=5 Participants	2083 Participants n=7 Participants	4149 Participants n=5 Participants
Race (NIH/OMB) More than one race	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months)

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

MACE is a composite endpoint including non-fatal myocardial infraction (MI), non-fatal stroke and cardiovascular (CV) death as adjudicated by Clinical Events Committee (CEC).

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event	182 Participants	190 Participants

PRIMARY outcome

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months)

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

MACE is a composite endpoint including non-fatal MI, non-fatal stroke and CV death as adjudicated by CEC.

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Time From Randomization to the First Component Event of MACE	NA months Median and 95% confidence interval (CI) could not be calculated due to an insufficient number of events.	NA months Median and 95% confidence interval (CI) could not be calculated due to an insufficient number of events.

SECONDARY outcome

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months).

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) as adjudicated by CEC.

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event	269 Participants	264 Participants

SECONDARY outcome

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months).

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac PCI, or CABG as adjudicated by CEC.

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Time From Randomization to the First Component Event of CV Safety Endpoint	NA months Median and 95% CI could not be calculated due to an insufficient number of events.	NA months Median and 95% CI could not be calculated due to an insufficient number of events.

SECONDARY outcome

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months).

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Presented as the number and percentage of participants with any high grade prostate cancer, defined as Gleason grade of 4 + 3 or higher, as adjudicated by Prostate Safety Events Committee (PAC). This grade is based on how abnormal prostate cells appear. Grade 1: cells look almost like normal prostate cells; Grade 5; cells look very different from normal prostate cells. Since most prostate cancers contain cells of different grades, the 2 most common grades are used. Gleason score is determined by adding the 2 most common grades. Higher numbers indicate a faster growing cancer that is more likely to spread. Currently the lowest score assigned to a tumor is grade 3. Grades below 3 show normal to near normal cells. Most cancers have a Gleason score (the sum of the 2 most common grades) of 6 (Gleason scores of 3+3) or 7 (Gleason scores of 3+4 or 4+3).

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Incidence of High-Grade Prostate Cancer	5 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From Baseline to Months 6, 12, and 24

Population: TRAVERSE Sexual Function Sub-Study: participants in the TRAVERSE main study full analysis set (i.e., randomized, no duplicate/triplicate participant IDs) who were eligible for the sexual function sub-study.

PDQ-Q4 asks 12 yes/no questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity.

Outcome measures

Measure	AndroGel 1.62% n=260 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=259 Participants Participants received matching placebo OD.
Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24 Change at Month 6	1.03 score on a scale Interval 0.82 to 1.24	0.54 score on a scale Interval 0.32 to 0.75
Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24 Change at Month 12	0.97 score on a scale Interval 0.72 to 1.23	0.50 score on a scale Interval 0.25 to 0.76
Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24 Change at Month 24	0.94 score on a scale Interval 0.6 to 1.28	0.46 score on a scale Interval 0.11 to 0.82

OTHER_PRE_SPECIFIED outcome

Timeframe: Months 6, 12, 24

Population: PDD Sub-Study participants (those included TRAVERSE main study full analysis set participants \[i.e., randomized, no duplicate/triplicate participant IDs\] who met the criteria for low-grade PDD) with an assessment at given time point.

The remission of low-grade, late-onset PDD was defined as: a) Patient Health Questionnaire (PHQ-9) score less than 4 and Geriatric Depression Scale-15 (GDS-15) score <5, and b) answer "no" to the question "Give your best guess: Over the past 6 months, have you been feeling sad or depressed more days than not, even if you felt okay sometimes?" The PHQ-9 is a 9-item depression scale. Total scores can range from 0 to 27, with higher scores indicating a worse outcome. A total score of 0-4 indicates minimal depression severity. The GDS-15 is a series of 15 yes/no questions asking how the participant felt in the past week. A score greater that 5 indicates depression; a higher score indicates a worse outcome.

Outcome measures

Measure	AndroGel 1.62% n=17 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=17 Participants Participants received matching placebo OD.
Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition Month 6	12 Participants	6 Participants
Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition Month 12	7 Participants	5 Participants
Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition Month 24	5 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months).

Population: TRAVERSE Main Study Full Analysis Set: all randomized participants without duplicate/triplicate participant IDs.

Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the Fracture Adjudication Committee (FAC). Fractures of the sternum, fingers, toes, facial bones and skull were excluded.

Outcome measures

Measure	AndroGel 1.62% n=2601 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2603 Participants Participants received matching placebo OD.
Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event	91 Participants	64 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to event or maximum follow-up (up to approximately 52 months).

Population: TRAVERSE Main Study Full Analysis Set: all randomized participants without duplicate/triplicate participant IDs.

Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the FAC. Fractures of the sternum, fingers, toes, facial bones and skull were excluded.

Outcome measures

Measure	AndroGel 1.62% n=2601 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2603 Participants Participants received matching placebo OD.
Time From Randomization to First Clinical Fracture	NA months Median and 95% CI could not be calculated due to an insufficient number of events.	NA months Median and 95% CI could not be calculated due to an insufficient number of events.

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Months 6, 12, 24, 36 and 48

Population: All randomized participants in TRAVERSE main study who had anemia at baseline; participants with an assessment at given time point.

The correction of anemia was defined as an increase in hemoglobin level >12.7 g/dL during the intervention period (at Months 6, 12, 24, 36 and 48) for participants in TRAVERSE main study with anemia at baseline.

Outcome measures

Measure	AndroGel 1.62% n=349 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=375 Participants Participants received matching placebo OD.
Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period Month 6	143 Participants	103 Participants
Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period Month 12	152 Participants	122 Participants
Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period Month 24	124 Participants	95 Participants
Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period Month 36	94 Participants	76 Participants
Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period Month 48	41 Participants	38 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Months 6, 12, 24, 36 and 48

Population: All randomized participants in TRAVERSE main study who had prediabetes at baseline; participants with an assessment at given time point.

Number and percentage of participants in each arm who had prediabetes at baseline progressing to diabetes, defined as hemoglobin A1C (HbA1C) equal to or higher than 6.5%, initiation of diabetes medication, or two consecutive fasting glucose levels >125 mg/dL, assessed at all available time points after baseline.

Outcome measures

Measure	AndroGel 1.62% n=598 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=562 Participants Participants received matching placebo OD.
Number and Percentage of Participants With Pre-Diabetes at Baseline Who Progressed to Diabetes at Months 6, 12, 24, 36 and 48 Month 6	4 Participants	8 Participants
Number and Percentage of Participants With Pre-Diabetes at Baseline Who Progressed to Diabetes at Months 6, 12, 24, 36 and 48 Month 12	45 Participants	57 Participants
Number and Percentage of Participants With Pre-Diabetes at Baseline Who Progressed to Diabetes at Months 6, 12, 24, 36 and 48 Month 24	50 Participants	67 Participants
Number and Percentage of Participants With Pre-Diabetes at Baseline Who Progressed to Diabetes at Months 6, 12, 24, 36 and 48 Month 36	46 Participants	52 Participants
Number and Percentage of Participants With Pre-Diabetes at Baseline Who Progressed to Diabetes at Months 6, 12, 24, 36 and 48 Month 48	22 Participants	19 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to event or last known date if no date (up to approximately 52 months).

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Presented as the number and percentage of participants who died, regardless of cause.

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Tertiary Endpoint: Incidence Rate of All Cause Mortality	144 Participants	148 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to event or last known date if no date (up to approximately 52 months).

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Presented as the number and percentage of participants with heart failure events (requiring hospitalization and/or urgent visit), as adjudicated by CEC.

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Tertiary Endpoint: Incidence Rate of Heart Failure	55 Participants	50 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to event or last known date if no date (up to approximately 52 months).

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Presented as the number and percentage of participants with venous thromboembolic events, as adjudicated by CEC. Events include deep vein thrombosis, pulmonary embolism, venous thromboembolism (excluding superficial thrombophlebitis).

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Tertiary Endpoint: Incidence Rate of Venous Thromboembolic Events	44 Participants	30 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months).

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Presented as the number and percentage of participants with peripheral arterial revascularization, as adjudicated by CEC.

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Tertiary Endpoint: Incidence Rate of Peripheral Arterial Revascularization	30 Participants	33 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months).

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Presented as the number and percentage of participants who underwent prostate biopsy.

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Tertiary Endpoint: Incidence Rate of Prostate Biopsy	16 Participants	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months).

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Presented as the number and percentage of participants who with prostate cancer, as adjudicated by Prostate Safety Events Committee (PAC).

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Tertiary Endpoint: Incidence Rate of Prostate Cancer	12 Participants	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months).

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Presented as the number and percentage of participants with acute urinary retention, as adjudicated by PAC.

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Tertiary Endpoint: Incidence Rate of Acute Urinary Retention	20 Participants	16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months).

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Presented as the number and percentage of participants who started pharmacologic treatment for lower urinary tract symptoms.

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Tertiary Endpoint: Incidence Rate of Pharmacologic Treatment for Lower Urinary Tract Symptoms	101 Participants	87 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to event or last known date if no event (up to approximately 52 months).

Population: TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Presented as the number and percentage of participants who underwent invasive prostate surgical procedures for benign prostate hyperplasia, as adjudicated by Prostate Safety Events Committee (PAC). Invasive prostate surgical procedures include prostatectomy, transurethral prostate resection, brachytherapy or other prostate surgical procedure.

Outcome measures

Measure	AndroGel 1.62% n=2596 Participants Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2602 Participants Participants received matching placebo OD.
Tertiary Endpoint: Incidence Rate of Invasive Prostate Surgical Procedures for Benign Prostatic Hyperplasia	23 Participants	12 Participants

Adverse Events

AndroGel 1.62% Predose

Serious events: 19 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Predose

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

AndroGel 1.62%

Serious events: 585 serious events

Other events: 160 other events

Deaths: 144 deaths

Placebo

Serious events: 562 serious events

Other events: 170 other events

Deaths: 148 deaths

Serious adverse events

Measure	AndroGel 1.62% Predose n=2601 participants at risk Participants randomized to the AndroGel 1.62% arm, prior to first dose.	Placebo Predose n=2603 participants at risk Participants randomized to the Placebo arm, prior to first dose.	AndroGel 1.62% n=2601 participants at risk Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2603 participants at risk Participants received matching placebo OD.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.27% 7/2601 • Number of events 7 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2603 • Number of events 7 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Blood and lymphatic system disorders BLOOD LOSS ANAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders GASTROINTESTINAL DISORDER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Blood and lymphatic system disorders LEUKOCYTOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Blood and lymphatic system disorders POLYCYTHAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ACUTE CORONARY SYNDROME	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ACUTE LEFT VENTRICULAR FAILURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.2% 30/2601 • Number of events 31 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.2% 30/2603 • Number of events 31 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ANGINA PECTORIS	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.38% 10/2601 • Number of events 10 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.85% 22/2603 • Number of events 23 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ANGINA UNSTABLE	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.73% 19/2601 • Number of events 20 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.2% 32/2603 • Number of events 35 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders AORTIC VALVE INCOMPETENCE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders AORTIC VALVE STENOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ARTERIOSCLEROSIS CORONARY ARTERY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ATRIAL FIBRILLATION	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.4% 37/2601 • Number of events 40 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.2% 30/2603 • Number of events 35 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ATRIAL FLUTTER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.35% 9/2601 • Number of events 9 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2603 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ATRIAL TACHYCARDIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ATRIOVENTRICULAR BLOCK FIRST DEGREE	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2601 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.50% 13/2603 • Number of events 14 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ATRIOVENTRICULAR BLOCK SECOND DEGREE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders BRADYCARDIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2601 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders BUNDLE BRANCH BLOCK LEFT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2601 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2603 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders BUNDLE BRANCH BLOCK RIGHT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.38% 10/2601 • Number of events 11 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.27% 7/2603 • Number of events 7 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CARDIAC ARREST	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.50% 13/2601 • Number of events 13 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.35% 9/2603 • Number of events 9 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CARDIAC FAILURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2601 • Number of events 7 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.27% 7/2603 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CARDIAC FAILURE ACUTE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.54% 14/2601 • Number of events 14 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.50% 13/2603 • Number of events 13 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CARDIAC FAILURE CHRONIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.88% 23/2601 • Number of events 29 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.96% 25/2603 • Number of events 32 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CARDIOGENIC SHOCK	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CARDIOMYOPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2603 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CARDIOPULMONARY FAILURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CARDIOVASCULAR DISORDER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CHRONIC LEFT VENTRICULAR FAILURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.2% 32/2601 • Number of events 33 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.3% 35/2603 • Number of events 40 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CORONARY ARTERY OCCLUSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.27% 7/2601 • Number of events 7 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders CORONARY ARTERY STENOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2601 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders DEFECT CONDUCTION INTRAVENTRICULAR	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ENDOCARDITIS NONINFECTIVE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders HYPERTENSIVE HEART DISEASE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders INTRACARDIAC THROMBUS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders ISCHAEMIC CARDIOMYOPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders LEFT VENTRICULAR FAILURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders MITRAL VALVE INCOMPETENCE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.92% 24/2601 • Number of events 25 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.81% 21/2603 • Number of events 21 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders MYOCARDIAL INJURY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders PALPITATIONS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders PERICARDIAL EFFUSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders PERICARDITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders PULSELESS ELECTRICAL ACTIVITY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders SINUS ARRHYTHMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders SINUS BRADYCARDIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2601 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.42% 11/2603 • Number of events 12 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2601 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.27% 7/2603 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders SINUS NODE DYSFUNCTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders SINUS TACHYCARDIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.27% 7/2601 • Number of events 7 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.42% 11/2603 • Number of events 11 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders SUPRAVENTRICULAR EXTRASYSTOLES	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders TACHYCARDIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.35% 9/2601 • Number of events 9 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders TRICUSPID VALVE INCOMPETENCE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders VENTRICULAR ARRHYTHMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders VENTRICULAR FIBRILLATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Cardiac disorders VENTRICULAR TACHYCARDIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.35% 9/2601 • Number of events 9 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.27% 7/2603 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Congenital, familial and genetic disorders CEREBRAL CAVERNOUS MALFORMATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Congenital, familial and genetic disorders GASTROINTESTINAL ARTERIOVENOUS MALFORMATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Congenital, familial and genetic disorders PHIMOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Ear and labyrinth disorders VERTIGO	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Endocrine disorders HYPERPARATHYROIDISM	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Endocrine disorders THYROID CYST	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Eye disorders BLINDNESS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Eye disorders BLINDNESS UNILATERAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Eye disorders DIPLOPIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Eye disorders RETINAL ARTERY OCCLUSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Eye disorders VISION BLURRED	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Eye disorders VISUAL IMPAIRMENT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Ear and labyrinth disorders VERTIGO POSITIONAL	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders ABDOMINAL WALL HAEMATOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders ASCITES	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders BARRETT'S OESOPHAGUS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders COLITIS ULCERATIVE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders COLON DYSPLASIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders CONSTIPATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders CROHN'S DISEASE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders DIVERTICULUM	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders DIVERTICULUM INTESTINAL HAEMORRHAGIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders DUODENAL PERFORATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders DUODENAL STENOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders DUODENAL ULCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders DUODENAL ULCER HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders GASTRIC HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders GASTRIC ULCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders GASTRIC ULCER HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders GASTRITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders HAEMATOCHEZIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders HYPOAESTHESIA ORAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders IMPAIRED GASTRIC EMPTYING	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders INGUINAL HERNIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders INTESTINAL ISCHAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders LARGE INTESTINE POLYP	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders LOWER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders NAUSEA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders OBSTRUCTIVE PANCREATITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders OESOPHAGITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders PANCREATIC MASS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders PANCREATITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2601 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders PANCREATITIS ACUTE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders PNEUMOPERITONEUM	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders RECTAL FISSURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders VOMITING	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders ASTHENIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders CARDIAC DEATH	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders CHEST DISCOMFORT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders CHEST PAIN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders DEATH	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2601 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2603 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders DROWNING	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders ELECTROCUTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders FATIGUE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders HERNIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders HYPOTHERMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders IMPAIRED HEALING	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders INFLAMMATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders MEDICAL DEVICE PAIN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders MULTIPLE ORGAN DYSFUNCTION SYNDROME	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders NON-CARDIAC CHEST PAIN	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.77% 20/2601 • Number of events 21 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.61% 16/2603 • Number of events 16 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders OEDEMA PERIPHERAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders ORGAN FAILURE	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders PAIN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders PELVIC MASS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders PERIPHERAL SWELLING	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders PYREXIA	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders SOFT TISSUE INFLAMMATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders STENT-GRAFT ENDOLEAK	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders SUDDEN CARDIAC DEATH	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders TREATMENT NONCOMPLIANCE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders UNEVALUABLE EVENT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders VASCULAR STENT OCCLUSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
General disorders VASCULAR STENT STENOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders DIARRHOEA HAEMORRHAGIC	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Gastrointestinal disorders IRRITABLE BOWEL SYNDROME	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Hepatobiliary disorders BILE DUCT STONE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Hepatobiliary disorders BILIARY DYSKINESIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2601 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Hepatobiliary disorders CHOLECYSTITIS CHRONIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Hepatobiliary disorders HEPATIC MASS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Immune system disorders ANAPHYLACTIC REACTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Immune system disorders CONTRAST MEDIA ALLERGY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Immune system disorders IMMUNISATION REACTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ABSCESS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ABSCESS LIMB	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ACINETOBACTER INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations APPENDICITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations APPENDICITIS PERFORATED	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ARTHRITIS BACTERIAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ARTHRITIS INFECTIVE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ATYPICAL PNEUMONIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations BACTERAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations BRONCHITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2603 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations CANDIDA SEPSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations CELLULITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.85% 22/2601 • Number of events 24 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.3% 35/2603 • Number of events 35 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations CELLULITIS GANGRENOUS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations CELLULITIS OF MALE EXTERNAL GENITAL ORGAN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations CELLULITIS STAPHYLOCOCCAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations CITROBACTER INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations CLOSTRIDIUM DIFFICILE INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations CORONAVIRUS INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations COVID-19	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.5% 38/2601 • Number of events 38 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.73% 19/2603 • Number of events 19 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations COVID-19 PNEUMONIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.0% 27/2601 • Number of events 27 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.85% 22/2603 • Number of events 22 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations DEVICE RELATED BACTERAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations DEVICE RELATED INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations DIABETIC FOOT INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations DIVERTICULITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2601 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations EMPYEMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ENDOCARDITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ENDOCARDITIS BACTERIAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ENDOPHTHALMITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ENTEROBACTER INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ENTEROCOCCAL BACTERAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations EPIDIDYMITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ERYSIPELAS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ESCHERICHIA SEPSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations EXTRADURAL ABSCESS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations GANGRENE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2601 • Number of events 7 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations GASTROENTERITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations GASTROENTERITIS VIRAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations HAEMATOMA INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations HEPATITIS A	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations INFLUENZA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2601 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations INTERVERTEBRAL DISCITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations KLEBSIELLA INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations KLEBSIELLA SEPSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations LOCALISED INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.35% 9/2603 • Number of events 9 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations MASTOIDITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations MEDICAL DEVICE SITE INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations MENINGITIS BACTERIAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations NECROTISING SOFT TISSUE INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations ORCHITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations OSTEOMYELITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.54% 14/2601 • Number of events 18 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.58% 15/2603 • Number of events 17 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations OSTEOMYELITIS ACUTE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PNEUMOCOCCAL BACTERAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PNEUMONIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.4% 37/2601 • Number of events 42 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.3% 35/2603 • Number of events 37 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PNEUMONIA ASPIRATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2601 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PNEUMONIA KLEBSIELLA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PNEUMONIA LEGIONELLA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PNEUMONIA PSEUDOMONAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PNEUMONIA STAPHYLOCOCCAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PNEUMONIA VIRAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations POST PROCEDURAL INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations POST-ACUTE COVID-19 SYNDROME	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PROSTATIC ABSCESS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PROTEUS INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PSEUDOMONAS INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PYELONEPHRITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations PYELONEPHRITIS ACUTE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations RHINOVIRUS INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations SCROTAL ABSCESS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations SCROTAL CELLULITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations SCROTAL INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations SEPSIS	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.77% 20/2601 • Number of events 20 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.81% 21/2603 • Number of events 21 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations SEPSIS SYNDROME	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations SEPTIC CEREBRAL EMBOLISM	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations SEPTIC ENCEPHALOPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations SEPTIC SHOCK	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2601 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations STAPHYLOCOCCAL OSTEOMYELITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations STREPTOCOCCAL BACTERAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations STREPTOCOCCAL SEPSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations SUBACUTE ENDOCARDITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations TOOTH ABSCESS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations URETHRAL ABSCESS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2603 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations UROSEPSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Infections and infestations WOUND INFECTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications ACCIDENT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications ACCIDENTAL OVERDOSE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications ANAEMIA POSTOPERATIVE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications ARTERIAL INJURY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications ARTHROPOD BITE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications AVULSION FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications CERVICAL VERTEBRAL FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications CLAVICLE FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications COMMINUTED FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications CRANIOCEREBRAL INJURY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications CRUSH INJURY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications DEEP VEIN THROMBOSIS POSTOPERATIVE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications DIFFUSE AXONAL INJURY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications FACIAL BONES FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications FALL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2601 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.46% 12/2603 • Number of events 12 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications FIBULA FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications FOOT FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications FOREIGN BODY IN THROAT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications FRACTURE DISPLACEMENT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications GASTROINTESTINAL INJURY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications HAND FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications HEAD INJURY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications HEAT STROKE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications HIP FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications IATROGENIC INJURY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications LIGAMENT RUPTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications LIMB TRAUMATIC AMPUTATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications MULTIPLE FRACTURES	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications MULTIPLE INJURIES	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications MUSCLE STRAIN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications OPEN FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications OVERDOSE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications PATELLA FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications PELVIC FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications PERIPROSTHETIC FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMATOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications POSTOPERATIVE RESPIRATORY FAILURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications POSTOPERATIVE THORACIC PROCEDURE COMPLICATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications PROCEDURAL HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications PULMONARY CONTUSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications RADIUS FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications RIB FRACTURE	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2603 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2601 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications SCAPULA FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications SKIN ABRASION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications SKIN LACERATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications SKULL FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications SPINAL FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications SPLENIC RUPTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications STERNAL FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications THIRD DEGREE CHEMICAL BURN OF SKIN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications THORACIC VERTEBRAL FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications TIBIA FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications TOXICITY TO VARIOUS AGENTS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications TRAUMATIC LIVER INJURY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications ULNA FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications URINARY TRACT PROCEDURAL COMPLICATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications VASCULAR GRAFT OCCLUSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications WOUND	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications WRIST FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Investigations BLOOD PRESSURE INCREASED	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Investigations BRAIN NATRIURETIC PEPTIDE INCREASED	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Investigations EJECTION FRACTION DECREASED	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Investigations HAEMOGLOBIN DECREASED	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Investigations LIVER FUNCTION TEST INCREASED	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Investigations PROCALCITONIN INCREASED	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Investigations PROSTATIC SPECIFIC ANTIGEN INCREASED	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Investigations SARS-COV-2 TEST NEGATIVE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Investigations TROPONIN INCREASED	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications JAW FRACTURE	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications PROCEDURAL COMPLICATION	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications STRESS FRACTURE	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Injury, poisoning and procedural complications TRAUMATIC RENAL INJURY	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Investigations SINUS RHYTHM	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2601 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2601 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2603 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders DIABETIC KETOACIDOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2603 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders FAILURE TO THRIVE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders HYPERKALAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2603 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders HYPERLIPIDAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders HYPERNATRAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders HYPERVOLAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2603 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders HYPOVOLAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders KETOACIDOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders LACTIC ACIDOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders METABOLIC ACIDOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders OBESITY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders POLYDIPSIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Metabolism and nutrition disorders TYPE 2 DIABETES MELLITUS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2601 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2603 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders CERVICAL SPINAL STENOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders COSTOCHONDRITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders GROIN PAIN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DEGENERATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DISORDER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders LIMB DISCOMFORT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2601 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders NECK DEFORMITY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.54% 14/2601 • Number of events 16 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.69% 18/2603 • Number of events 18 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders PATHOLOGICAL FRACTURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders PERIARTHRITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders POLYMYALGIA RHEUMATICA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders SPINAL STENOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders SPONDYLOLISTHESIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders TEMPOROMANDIBULAR JOINT SYNDROME	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders VERTEBRAL FORAMINAL STENOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Musculoskeletal and connective tissue disorders CHEST WALL HAEMATOMA	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE MYELOID LEUKAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA GASTRIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA METASTATIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA OF COLON	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER TRANSITIONAL CELL CARCINOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BONE CANCER METASTATIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CARCINOID TUMOUR OF THE SMALL BOWEL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHOLANGIOCARCINOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHRONIC LYMPHOCYTIC LEUKAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CLEAR CELL RENAL CELL CARCINOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER METASTATIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLORECTAL ADENOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) DIFFUSE LARGE B-CELL LYMPHOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) FOLLICULAR THYROID CANCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROINTESTINAL NEOPLASM	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROINTESTINAL STROMAL TUMOUR	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC CANCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC CANCER METASTATIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HODGKIN'S DISEASE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LARYNGEAL SQUAMOUS CELL CARCINOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LEUKAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIPOSARCOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CANCER METASTATIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG SQUAMOUS CELL CARCINOMA STAGE II	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT ASCITES	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA STAGE IV	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MANTLE CELL LYMPHOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MENINGIOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MENINGIOMA BENIGN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LIVER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LUNG	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LYMPH NODES	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MONOCLONAL GAMMOPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE CARCINOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER METASTATIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER STAGE IIIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER STAGE IV	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL CARCINOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OROPHARYNGEAL SQUAMOUS CELL CARCINOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA METASTATIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PARATHYROID TUMOUR BENIGN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PITUITARY TUMOUR	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PITUITARY TUMOUR BENIGN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PLASMA CELL MYELOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PLASMA CELL MYELOMA RECURRENT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2601 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.27% 7/2603 • Number of events 7 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL CANCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL CANCER METASTATIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL CANCER STAGE III	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SALIVARY GLAND CANCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN CANCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL CELL LUNG CANCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THROAT CANCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TRANSITIONAL CELL CARCINOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders ALTERED STATE OF CONSCIOUSNESS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders AMNESIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders APHASIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders ATAXIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders AUTONOMIC NEUROPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders BELL'S PALSY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders BRAIN STEM HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CAROTID ARTERY OCCLUSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CAROTID ARTERY STENOSIS	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CARPAL TUNNEL SYNDROME	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CAUDA EQUINA SYNDROME	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CEREBELLAR INFARCTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CEREBELLAR STROKE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CEREBRAL HAEMATOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CEREBRAL HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CEREBRAL INFARCTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CEREBRAL VENTRICLE DILATATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.35% 9/2601 • Number of events 9 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.50% 13/2603 • Number of events 13 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CERVICAL CORD COMPRESSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CERVICAL RADICULOPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CLONIC CONVULSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders CRANIAL NERVE PARALYSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders DIABETIC NEUROPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders DIZZINESS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2601 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2603 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders DYSARTHRIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders ENCEPHALOPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders ESSENTIAL TREMOR	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders GUILLAIN-BARRE SYNDROME	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders HAEMORRHAGIC STROKE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders HAEMORRHAGIC TRANSFORMATION STROKE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders HEADACHE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders HEMIPARESIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders HEPATIC ENCEPHALOPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders HYPOAESTHESIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders HYPOXIC-ISCHAEMIC ENCEPHALOPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders INTRACRANIAL HAEMATOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders ISCHAEMIC CEREBRAL INFARCTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders ISCHAEMIC STROKE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.46% 12/2601 • Number of events 12 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2603 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders LACUNAR INFARCTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders LACUNAR STROKE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders LOSS OF CONSCIOUSNESS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders LUMBAR RADICULOPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders MENINGEAL THICKENING	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders METABOLIC ENCEPHALOPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders MIGRAINE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders MULTIPLE SCLEROSIS RELAPSE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders MYASTHENIA GRAVIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders MYELOPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders NERVOUS SYSTEM DISORDER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders NEUROPATHY PERIPHERAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders NORMAL PRESSURE HYDROCEPHALUS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders PARAESTHESIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders PARALYSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders PRESYNCOPE	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2601 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2603 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders QUADRIPARESIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders RADIAL NERVE PALSY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders RADICULOPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders SCIATICA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders SEIZURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders SPEECH DISORDER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders SPINAL CLAUDICATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders SYNCOPE	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.85% 22/2601 • Number of events 27 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.85% 22/2603 • Number of events 23 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders THROMBOTIC STROKE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders TOXIC ENCEPHALOPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders TRANSIENT GLOBAL AMNESIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2601 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.50% 13/2603 • Number of events 13 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders TRIGEMINAL NEURALGIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF HEAD AND NECK	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Nervous system disorders SPINAL EPIDURAL HAEMORRHAGE	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Product Issues DEVICE DISLOCATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Product Issues DEVICE FAILURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Product Issues DEVICE OCCLUSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders ADJUSTMENT DISORDER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders AGGRESSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders AGITATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders ALCOHOL ABUSE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders ANXIETY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders BIPOLAR II DISORDER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders COMPLETED SUICIDE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders DELIRIUM	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders DEPRESSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders MAJOR DEPRESSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders MANIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders MENTAL STATUS CHANGES	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders PANIC ATTACK	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders PERSONALITY DISORDER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders POST-TRAUMATIC STRESS DISORDER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders PSYCHOTIC DISORDER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Psychiatric disorders SUICIDE ATTEMPT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.2% 31/2601 • Number of events 31 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.96% 25/2603 • Number of events 25 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders CALCULUS BLADDER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders CALCULUS URINARY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders CHRONIC KIDNEY DISEASE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2601 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders DYSURIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders END STAGE RENAL DISEASE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders HAEMATURIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders HYDRONEPHROSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2601 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2603 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders OBSTRUCTIVE NEPHROPATHY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders POLYURIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders RENAL ARTERY STENOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders RENAL COLIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders RENAL FAILURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders RENAL HAEMATOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders RENAL HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders RENAL TUBULAR NECROSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders URETERIC OBSTRUCTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders URETEROLITHIASIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders URETHRAL OBSTRUCTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders URINARY BLADDER HERNIATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Renal and urinary disorders URINARY RETENTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.35% 9/2601 • Number of events 9 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.35% 9/2603 • Number of events 9 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Reproductive system and breast disorders PRIAPISM	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Reproductive system and breast disorders PROSTATOMEGALY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	1.4% 36/2601 • Number of events 39 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.92% 24/2603 • Number of events 26 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders ASPIRATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders BRONCHIAL HYPERREACTIVITY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders BRONCHIECTASIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders BRONCHITIS CHRONIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.50% 13/2601 • Number of events 16 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.50% 13/2603 • Number of events 14 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders CHRONIC RESPIRATORY FAILURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2601 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2603 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders HYPERCAPNIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.46% 12/2601 • Number of events 13 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders LUNG CONSOLIDATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders OBSTRUCTIVE SLEEP APNOEA SYNDROME	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders PHARYNGEAL OEDEMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders PLEURITIC PAIN	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders PNEUMOMEDIASTINUM	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.65% 17/2601 • Number of events 17 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2603 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders PULMONARY FISTULA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders PULMONARY MASS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders RESPIRATORY ARREST	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2601 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2603 • Number of events 6 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Respiratory, thoracic and mediastinal disorders TRACHEAL CALCIFICATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Skin and subcutaneous tissue disorders ANGIOEDEMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Skin and subcutaneous tissue disorders DIABETIC FOOT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2603 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Skin and subcutaneous tissue disorders DIABETIC ULCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Skin and subcutaneous tissue disorders DIABETIC WOUND	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Skin and subcutaneous tissue disorders SKIN LESION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Skin and subcutaneous tissue disorders SKIN ULCER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Social circumstances IMMOBILE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Surgical and medical procedures AMPUTATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Surgical and medical procedures ANGIOPLASTY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Surgical and medical procedures CARDIAC PACEMAKER REPLACEMENT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Surgical and medical procedures HIP ARTHROPLASTY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Surgical and medical procedures KNEE ARTHROPLASTY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Surgical and medical procedures LEG AMPUTATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Surgical and medical procedures SPINAL FUSION SURGERY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Surgical and medical procedures STENT PLACEMENT	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Surgical and medical procedures TOE AMPUTATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders AORTIC ANEURYSM	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders AORTIC STENOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders ARTERIAL HAEMORRHAGE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders ARTERIAL THROMBOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders ARTERIOSCLEROSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2601 • Number of events 9 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.38% 10/2603 • Number of events 10 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders HAEMATOMA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders HYPERTENSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2603 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders HYPERTENSIVE CRISIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders HYPERTENSIVE EMERGENCY	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders HYPERTENSIVE URGENCY	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders HYPOTENSION	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2601 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.31% 8/2603 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders ILIAC ARTERY STENOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders INTERMITTENT CLAUDICATION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2601 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders MALIGNANT HYPERTENSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders ORTHOSTATIC HYPOTENSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2601 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2601 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.23% 6/2603 • Number of events 8 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders PERIPHERAL ARTERY ANEURYSM	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders PERIPHERAL ARTERY OCCLUSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders PERIPHERAL ARTERY STENOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.15% 4/2603 • Number of events 4 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders PERIPHERAL ARTERY THROMBOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders PERIPHERAL ISCHAEMIA	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders PERIPHERAL VASCULAR DISORDER	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.19% 5/2601 • Number of events 5 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.12% 3/2603 • Number of events 3 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders PERIPHERAL VENOUS DISEASE	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders SHOCK HAEMORRHAGIC	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders SUBCLAVIAN VEIN THROMBOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2601 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders THROMBOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.08% 2/2601 • Number of events 2 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders VASCULAR COMPRESSION	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders VASCULAR STENOSIS	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.
Vascular disorders VENOUS THROMBOSIS LIMB	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2603 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.00% 0/2601 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	0.04% 1/2603 • Number of events 1 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.

Other adverse events

Measure	AndroGel 1.62% Predose n=2601 participants at risk Participants randomized to the AndroGel 1.62% arm, prior to first dose.	Placebo Predose n=2603 participants at risk Participants randomized to the Placebo arm, prior to first dose.	AndroGel 1.62% n=2601 participants at risk Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	Placebo n=2603 participants at risk Participants received matching placebo OD.
Metabolism and nutrition disorders DIABETES MELLITUS	— 0/0 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	— 0/0 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	6.2% 160/2596 • Number of events 169 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.	6.5% 170/2602 • Number of events 183 • Serious adverse events (SAEs): from enrollment to 30 days post last dose (up to Month 48). Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months). Other AEs were not collected prior to first dose, per protocol.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place