Trial Outcomes & Findings for Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults (NCT NCT04516746)

NCT ID: NCT04516746

Last Updated: 2024-02-05

Results Overview

A binary response, whereby a participant with negative serostatus at baseline is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs ≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case. The primary efficacy analysis was performed once approximately 150 events meeting the primary efficacy outcome measure definition had occurred across the AZD1222 and placebo groups.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 32450 participants
• Primary outcome timeframe: From 15 days post second dose up to data cut-off date (DCO) of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks
• Results posted on: 2024-02-05

Participant Flow

This Phase III randomized study was conducted in adult participants who were healthy or had medically stable chronic diseases and were at increased risk for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) acquisition and coronavirus disease-2019 (COVID-19) at 88 centers in Chile, Peru and United States of America between 28 August 2020 and 10 February 2023.

The study had a screening period (14 days), followed by a treatment and follow-up period (up to 760 days). A total of 32450 participants were randomized in a 2:1 ratio to receive AZD1222 or placebo. One participant was enrolled at 2 sites and excluded from all analysis sets. The first participants randomized in each age group in the United States of America participated in a substudy to assess immunogenicity and reactogenicity.

Participant milestones

Measure	AZD1222 Participants were randomized to receive 2 intramuscular (IM) doses of 5\*10\^10 viral particles (vp) (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Overall Study STARTED	21634	10816
Overall Study Participants Who Received First Dose	21583	10797
Overall Study Participants Who Received Second Dose	20770	9954
Overall Study COMPLETED	16099	7213
Overall Study NOT COMPLETED	5535	3603

Reasons for withdrawal

Measure	AZD1222 Participants were randomized to receive 2 intramuscular (IM) doses of 5\*10\^10 viral particles (vp) (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Overall Study Randomized but not Treated	51	19
Overall Study Adverse Event	0	1
Overall Study Death	62	32
Overall Study Lost to Follow-up	3431	1831
Overall Study Withdrawal by Subject	1946	1696
Overall Study Physician Decision	10	8
Overall Study Other	35	16

Baseline Characteristics

Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults

Baseline characteristics by cohort

Measure	AZD1222 n=21634 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=10816 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.	Total n=32450 Participants Total of all reporting groups
Age, Continuous	50.2 years STANDARD_DEVIATION 15.92 • n=5 Participants	50.2 years STANDARD_DEVIATION 15.86 • n=7 Participants	50.2 years STANDARD_DEVIATION 15.90 • n=5 Participants
Sex: Female, Male Female	9603 Participants n=5 Participants	4797 Participants n=7 Participants	14400 Participants n=5 Participants
Sex: Female, Male Male	12031 Participants n=5 Participants	6019 Participants n=7 Participants	18050 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	4787 Participants n=5 Participants	2456 Participants n=7 Participants	7243 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	16506 Participants n=5 Participants	8217 Participants n=7 Participants	24723 Participants n=5 Participants
Race/Ethnicity, Customized Not reported	260 Participants n=5 Participants	138 Participants n=7 Participants	398 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	101 Participants n=5 Participants	53 Participants n=7 Participants	154 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	513 Participants n=5 Participants	258 Participants n=7 Participants	771 Participants n=5 Participants
Race/Ethnicity, Customized White	17100 Participants n=5 Participants	8534 Participants n=7 Participants	25634 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1798 Participants n=5 Participants	899 Participants n=7 Participants	2697 Participants n=5 Participants
Race/Ethnicity, Customized Asian	947 Participants n=5 Participants	483 Participants n=7 Participants	1430 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	855 Participants n=5 Participants	430 Participants n=7 Participants	1285 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	60 Participants n=5 Participants	21 Participants n=7 Participants	81 Participants n=5 Participants

PRIMARY outcome

Timeframe: From 15 days post second dose up to data cut-off date (DCO) of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Population: The fully vaccinated analysis set (FVS) included all participants in the full analysis set (FAS) who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.

A binary response, whereby a participant with negative serostatus at baseline is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs ≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case. The primary efficacy analysis was performed once approximately 150 events meeting the primary efficacy outcome measure definition had occurred across the AZD1222 and placebo groups.

Outcome measures

Measure	AZD1222 n=17662 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=8550 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Number of Participants With Binary Response	73 Participants	130 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 28 days post second dose of study intervention, approximately 57 days

Population: The safety analysis set included all participants who received at least 1 dose of study intervention from primary analysis data cut which is 1 participant less in placebo group than that from the final data cut.

An AE is the development of any untoward medical occurrence in a clinical study participant administered medicinal product and which does not necessarily have a causal relationship with this medicinal product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Measure	AZD1222 n=21587 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=10792 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Number of Participants With Adverse Events (AEs) Post Each Dose of Study Intervention After any dose	8771 Participants	3201 Participants
Number of Participants With Adverse Events (AEs) Post Each Dose of Study Intervention After first dose	5736 Participants	1926 Participants
Number of Participants With Adverse Events (AEs) Post Each Dose of Study Intervention After second dose	5074 Participants	1797 Participants

PRIMARY outcome

Timeframe: From Day 1 up to receipt of non-study COVID-19 vaccination or a maximum of Day 760 for participants without non-study COVID-19 vaccination.

Population: The safety analysis set included all participants who received at least 1 dose of study intervention.

An SAE is an AE occurring during any study phase that fulfils 1 or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. AESIs were events of scientific and medical interest specific to the further understanding of the study intervention safety profile and required close monitoring and rapid communication by the investigators to the sponsor. MAAEs are defined as AEs leading to medically-attended visits that were not routine visits for physical examination or vaccination, such as an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Different follow-up time between AZD1222 and Placebo groups (20223 versus 3893 participant years).

Outcome measures

Measure	AZD1222 n=21587 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=10793 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Number of Participants With Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE), and Adverse Event of Special Interest (AESI) Prior to Non-study COVID-19 Vaccination SAEs	621 Participants	136 Participants
Number of Participants With Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE), and Adverse Event of Special Interest (AESI) Prior to Non-study COVID-19 Vaccination MAAEs	4750 Participants	1256 Participants
Number of Participants With Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE), and Adverse Event of Special Interest (AESI) Prior to Non-study COVID-19 Vaccination AESIs	2516 Participants	591 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 7 days post each dose of study intervention, approximately 14 days

Population: The safety analysis set included all participants who received at least 1 dose of study intervention. Only participants included in the substudy were analyzed.

Solicited AEs are local or systemic predefined events for assessment of reactogenicity. Solicited AEs were collected in a e-Diary only for participants in the substudy.

Outcome measures

Measure	AZD1222 n=2037 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=1013 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Number of Participants With Local and Systemic Solicited AEs in the Substudy Only Solicited local AEs: After first dose	1250 Participants	173 Participants
Number of Participants With Local and Systemic Solicited AEs in the Substudy Only Solicited local AEs: After second dose	977 Participants	120 Participants
Number of Participants With Local and Systemic Solicited AEs in the Substudy Only Solicited local AEs: After any dose	1440 Participants	239 Participants
Number of Participants With Local and Systemic Solicited AEs in the Substudy Only Solicited systemic AEs: After first dose	1191 Participants	415 Participants
Number of Participants With Local and Systemic Solicited AEs in the Substudy Only Solicited systemic AEs: After second dose	862 Participants	314 Participants
Number of Participants With Local and Systemic Solicited AEs in the Substudy Only Solicited systemic AEs: After any dose	1395 Participants	519 Participants

SECONDARY outcome

Timeframe: From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Population: The FVS included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.

The incidence of the first post-intervention response (negative at baseline to positive post intervention with study intervention) for SARS-CoV-2 nucleocapsid antibodies occurring ≥ 15 days post second dose of study intervention (key secondary endpoint).

Outcome measures

Measure	AZD1222 n=17662 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=8550 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Number of Participants With First Post-intervention Response for SARS-CoV-2 Nucleocapsid Antibodies Post Second Dose of Study Intervention	156 Participants	202 Participants

SECONDARY outcome

Timeframe: From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Population: The FVS included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.

The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using CDC criteria. Participant must present with at least 1 of the following symptoms per CDC criteria: fever, shortness of breath, difficulty breathing, chills, cough, fatigue, muscle aches, body aches, headache, new loss of taste, new loss of smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea.

Outcome measures

Measure	AZD1222 n=17662 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=8550 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Number of Participants With First COVID-19 Symptomatic Illness Using Centers for Disease Control and Prevention (CDC) Criteria Post Second Dose of Study Intervention	95 Participants	145 Participants

SECONDARY outcome

Timeframe: From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Population: The FVS included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.

The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using University of Oxford-defined symptom criteria: new onset of fever (> 100 °Fahrenheit [> 37.8 °Celsius]), cough, shortness of breath, or anosmia/ageusia.

Outcome measures

Measure	AZD1222 n=17662 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=8550 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Number of Participants With First COVID-19 Symptomatic Illness Using University of Oxford-Defined Symptom Criteria Post Second Dose of Study Intervention	86 Participants	136 Participants

SECONDARY outcome

Timeframe: From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Population: The FVS regardless of prior SARS-COV-2 infection included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose.

The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring ≥ 15 days post second dose of study intervention regardless of evidence of prior SARS-CoV-2 infection (key secondary endpoint).

Outcome measures

Measure	AZD1222 n=18563 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=9031 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Number of Participants With First Symptomatic COVID-19 Regardless of Evidence of Prior SARS-CoV-2 Infection Post Second Dose of Study Intervention	76 Participants	135 Participants

SECONDARY outcome

Timeframe: From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Population: The FVS included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.

The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring ≥ 15 days post second dose of study intervention. The severity of COVID-19 was evaluated in participants with symptoms of COVID-19. Following are the findings regarding severe of critical symptomatic COVID-19: clinical signs at rest indicative of severe systemic illness; respiratory failure; evidence of shock; significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; and death (key secondary endpoint).

Outcome measures

Measure	AZD1222 n=17662 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=8550 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post Second Dose of Study Intervention	0 Participants	8 Participants

SECONDARY outcome

Timeframe: From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Population: The FAS included all randomized participants who received at least 1 dose of study intervention, irrespective of their protocol adherence and continued participation in the study. Only participants who are seronegative at baseline were analyzed.

The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring post first dose of study intervention. The severity of COVID-19 was evaluated in participants with symptoms of COVID-19. Following are the findings regarding severe of critical symptomatic COVID-19: clinical signs at rest indicative of severe systemic illness; respiratory failure; evidence of shock; significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; and death.

Outcome measures

Measure	AZD1222 n=20589 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=10300 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post First Dose of Study Intervention	5 Participants	16 Participants

SECONDARY outcome

Timeframe: From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks

Population: The FVS included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.

The incidence of COVID-19-related emergency department visits occurring ≥ 15 days post second dose of study intervention (key secondary endpoint).

Outcome measures

Measure	AZD1222 n=17662 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=8550 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Number of Participants With COVID-19-Related Emergency Department Visits Post Second Dose of Study Intervention	1 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Days 15, 29, 43, 57, 90, 180, 360, and 730

Population: The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed.

The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information.

Outcome measures

Measure	AZD1222 n=2008 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=1002 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay S Antibody Titer: Baseline (Day 1)	53.18 arbitrary units per milliliter (AU/mL) Interval 50.37 to 56.14	54.68 arbitrary units per milliliter (AU/mL) Interval 50.1 to 59.69
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay S Antibody Titer: Day 15	1820.10 arbitrary units per milliliter (AU/mL) Interval 1696.48 to 1952.72	53.47 arbitrary units per milliliter (AU/mL) Interval 48.88 to 58.5
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay S Antibody Titer: Day 29	5782.09 arbitrary units per milliliter (AU/mL) Interval 5389.88 to 6202.84	53.64 arbitrary units per milliliter (AU/mL) Interval 47.98 to 59.97
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay S Antibody Titer: Day 43	24105.87 arbitrary units per milliliter (AU/mL) Interval 22945.04 to 25325.44	58.15 arbitrary units per milliliter (AU/mL) Interval 52.68 to 64.18
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay S Antibody Titer: Day 57	19488.64 arbitrary units per milliliter (AU/mL) Interval 18521.81 to 20505.92	58.30 arbitrary units per milliliter (AU/mL) Interval 52.35 to 64.94
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay S Antibody Titer: Day 90	14583.30 arbitrary units per milliliter (AU/mL) Interval 13839.22 to 15367.38	87.51 arbitrary units per milliliter (AU/mL) Interval 74.78 to 102.42
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay S Antibody Titer: Day 180	7483.04 arbitrary units per milliliter (AU/mL) Interval 6911.35 to 8102.02	266.47 arbitrary units per milliliter (AU/mL) Interval 161.19 to 440.49
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay S Antibody Titer: Day 360	6686.81 arbitrary units per milliliter (AU/mL) Interval 5779.74 to 7736.24	1268.45 arbitrary units per milliliter (AU/mL) Interval 489.8 to 3284.98
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay S Antibody Titer: Day 730	186727.78 arbitrary units per milliliter (AU/mL) Interval 154395.93 to 225830.2	19093.94 arbitrary units per milliliter (AU/mL) Interval 5685.04 to 64129.44
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay RBD Antibody Titer: Baseline (Day 1)	133.6 arbitrary units per milliliter (AU/mL) Interval 129.1 to 138.4	138.9 arbitrary units per milliliter (AU/mL) Interval 130.9 to 147.3
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay RBD Antibody Titer: Day 15	965.0 arbitrary units per milliliter (AU/mL) Interval 897.0 to 1038.1	138.6 arbitrary units per milliliter (AU/mL) Interval 130.5 to 147.1
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay RBD Antibody Titer: Day 29	5176.6 arbitrary units per milliliter (AU/mL) Interval 4794.8 to 5588.9	143.0 arbitrary units per milliliter (AU/mL) Interval 132.4 to 154.3
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay RBD Antibody Titer: Day 43	29351.9 arbitrary units per milliliter (AU/mL) Interval 27875.6 to 30906.4	145.7 arbitrary units per milliliter (AU/mL) Interval 136.0 to 156.1
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay RBD Antibody Titer: Day 57	23840.6 arbitrary units per milliliter (AU/mL) Interval 22614.3 to 25133.3	151.6 arbitrary units per milliliter (AU/mL) Interval 140.3 to 163.8
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay RBD Antibody Titer: Day 90	17499.9 arbitrary units per milliliter (AU/mL) Interval 16559.1 to 18494.1	192.6 arbitrary units per milliliter (AU/mL) Interval 171.0 to 217.0
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay RBD Antibody Titer: Day 180	8333.1 arbitrary units per milliliter (AU/mL) Interval 7647.9 to 9079.7	481.6 arbitrary units per milliliter (AU/mL) Interval 314.8 to 736.7
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay RBD Antibody Titer: Day 360	7499.2 arbitrary units per milliliter (AU/mL) Interval 6417.7 to 8763.1	1912.3 arbitrary units per milliliter (AU/mL) Interval 839.0 to 4358.5
Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay RBD Antibody Titer: Day 730	276381.8 arbitrary units per milliliter (AU/mL) Interval 227665.9 to 335521.9	19319.4 arbitrary units per milliliter (AU/mL) Interval 5290.3 to 70551.9

SECONDARY outcome

Timeframe: Days 15, 29, 43, 57, 90, 180, 360, and 730

Population: The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed.

The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information.

Outcome measures

Measure	AZD1222 n=1885 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=943 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay S Antibody Titer: Day 15	34.28 ratio Interval 31.87 to 36.86	0.97 ratio Interval 0.94 to 1.0
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay S Antibody Titer: Day 29	108.35 ratio Interval 99.95 to 117.45	0.92 ratio Interval 0.87 to 0.96
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay S Antibody Titer: Day 43	455.38 ratio Interval 425.71 to 487.12	1.08 ratio Interval 1.02 to 1.14
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay S Antibody Titer: Day 57	373.44 ratio Interval 348.12 to 400.6	1.10 ratio Interval 1.02 to 1.19
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay S Antibody Titer: Day 90	274.05 ratio Interval 255.01 to 294.5	1.61 ratio Interval 1.41 to 1.85
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay S Antibody Titer: Day 180	138.44 ratio Interval 125.37 to 152.88	3.33 ratio Interval 2.07 to 5.37
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay S Antibody Titer: Day 360	121.12 ratio Interval 102.89 to 142.58	17.44 ratio Interval 6.75 to 45.07
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay S Antibody Titer: Day 730	3506.74 ratio Interval 2808.52 to 4378.55	295.66 ratio Interval 89.07 to 981.35
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay RBD Antibody Titer: Day 15	7.24 ratio Interval 6.76 to 7.76	1.00 ratio Interval 0.98 to 1.02
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay RBD Antibody Titer: Day 29	39.01 ratio Interval 36.1 to 42.17	1.01 ratio Interval 0.98 to 1.03
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay RBD Antibody Titer: Day 43	219.94 ratio Interval 207.28 to 233.37	1.05 ratio Interval 1.01 to 1.09
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay RBD Antibody Titer: Day 57	178.61 ratio Interval 167.97 to 189.92	1.10 ratio Interval 1.04 to 1.16
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay RBD Antibody Titer: Day 90	130.46 ratio Interval 122.53 to 138.89	1.41 ratio Interval 1.27 to 1.57
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay RBD Antibody Titer: Day 180	61.69 ratio Interval 56.27 to 67.62	3.13 ratio Interval 2.11 to 4.65
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay RBD Antibody Titer: Day 360	53.91 ratio Interval 45.86 to 63.37	11.18 ratio Interval 4.91 to 25.45
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay RBD Antibody Titer: Day 730	2103.65 ratio Interval 1706.88 to 2592.64	106.35 ratio Interval 29.93 to 377.87

SECONDARY outcome

Timeframe: Days 15, 29, 43, 57, 90, 180, 360, and 730

Population: The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed.

The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (≥ 4-fold rise in titers from baseline value to 28 days post each dose) to the S and RBD antigens of AZD1222 as measured by MSD serology assay is reported.

Outcome measures

Measure	AZD1222 n=1885 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=943 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay S Antibody Titer: Day 15	89.8 percentage of participants	1.1 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay S Antibody Titer: Day 29	97.1 percentage of participants	1.6 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay S Antibody Titer: Day 43	99.4 percentage of participants	2.5 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay S Antibody Titer: Day 57	99.3 percentage of participants	3.2 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay S Antibody Titer: Day 90	99.3 percentage of participants	8.9 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay S Antibody Titer: Day 180	98.3 percentage of participants	23.3 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay S Antibody Titer: Day 360	96.1 percentage of participants	54.3 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay S Antibody Titer: Day 730	100.0 percentage of participants	90.9 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay RBD Antibody Titer: Day 15	61.3 percentage of participants	0.4 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay RBD Antibody Titer: Day 29	92.2 percentage of participants	1.0 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay RBD Antibody Titer: Day 43	98.8 percentage of participants	2.0 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay RBD Antibody Titer: Day 57	98.7 percentage of participants	2.6 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay RBD Antibody Titer: Day 90	98.6 percentage of participants	7.7 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay RBD Antibody Titer: Day 180	96.3 percentage of participants	22.6 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay RBD Antibody Titer: Day 360	89.8 percentage of participants	50.0 percentage of participants
Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay RBD Antibody Titer: Day 730	99.3 percentage of participants	86.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Days 15, 29, 43, 57, 90, 180, and 360

Population: The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed.

The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information.

Outcome measures

Measure	AZD1222 n=1943 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=973 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Baseline (Day 1)	20.6 AU/mL Interval 20.3 to 20.9	21.4 AU/mL Interval 20.7 to 22.0
GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 15	41.7 AU/mL Interval 39.3 to 44.2	21.7 AU/mL Interval 20.9 to 22.4
GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 29	65.9 AU/mL Interval 60.8 to 71.4	23.0 AU/mL Interval 21.8 to 24.3
GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 43	221.3 AU/mL Interval 208.4 to 235.0	22.6 AU/mL Interval 21.6 to 23.5
GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 57	251.8 AU/mL Interval 235.7 to 269.0	23.3 AU/mL Interval 22.1 to 24.6
GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 90	206.1 AU/mL Interval 150.3 to 282.6	37.5 AU/mL Interval 15.0 to 94.1
GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 180	112.9 AU/mL Interval 90.4 to 141.0	51.3 AU/mL Interval 37.4 to 70.4
GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 360	265.7 AU/mL Interval 94.0 to 751.1	46.3 AU/mL Interval 20.1 to 106.4

SECONDARY outcome

Timeframe: Days 15, 29, 43, 57, 90, 180, and 360

Population: The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed.

The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information.

Outcome measures

Measure	AZD1222 n=1705 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=896 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 15	2.03 ratio Interval 1.92 to 2.15	1.01 ratio Interval 0.99 to 1.03
GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 29	3.24 ratio Interval 2.99 to 3.5	1.07 ratio Interval 1.02 to 1.11
GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 43	10.91 ratio Interval 10.27 to 11.58	1.05 ratio Interval 1.01 to 1.08
GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 57	12.32 ratio Interval 11.54 to 13.16	1.08 ratio Interval 1.03 to 1.14
GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 90	9.95 ratio Interval 7.33 to 13.51	1.94 ratio Interval 0.74 to 5.09
GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 180	5.37 ratio Interval 4.3 to 6.71	2.22 ratio Interval 1.65 to 3.0
GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay Day 360	12.64 ratio Interval 4.31 to 37.11	2.31 ratio Interval 1.01 to 5.32

SECONDARY outcome

Timeframe: Days 15, 29, 43, 57, 90, 180, and 360

Population: The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed.

The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (≥ 4-fold rise in titers from baseline value to 28 days post each dose) to SARS-CoV-2 neutralizing antibodies of AZD1222 as measured by pseudo-neutralization assay is reported.

Outcome measures

Measure	AZD1222 n=1705 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=896 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay Day 360	53.8 percentage of participants	28.6 percentage of participants
Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay Day 15	24.8 percentage of participants	0.3 percentage of participants
Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay Day 29	41.1 percentage of participants	1.8 percentage of participants
Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay Day 43	84.4 percentage of participants	1.9 percentage of participants
Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay Day 57	84.4 percentage of participants	2.2 percentage of participants
Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay Day 90	83.3 percentage of participants	10.0 percentage of participants
Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay Day 180	51.5 percentage of participants	22.0 percentage of participants

SECONDARY outcome

Timeframe: From Day 1 up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of approximately 27 weeks

Population: The FAS included all randomized participants who received at least 1 dose of study intervention, irrespective of their protocol adherence and continued participation in the study. Only participants who are seronegative at baseline were analyzed.

The incidence of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring post first dose of study intervention.

Outcome measures

Measure	AZD1222 n=20589 Participants Participants were randomized to receive 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=10300 Participants Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Number of Participants With COVID-19 Symptomatic Illness Post First Dose of Study Intervention	287 Participants	303 Participants

Adverse Events

AZD1222

Serious events: 1039 serious events

Other events: 11846 other events

Deaths: 62 deaths

Placebo

Serious events: 467 serious events

Other events: 4234 other events

Deaths: 33 deaths

Serious adverse events

Measure	AZD1222 n=21587 participants at risk Participants received 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=10793 participants at risk Participants received 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Injury, poisoning and procedural complications Chemical peritonitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Hand fracture	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Sternal fracture	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Thermal burn	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Ear and labyrinth disorders Deafness bilateral	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Endocrine disorders Thyroid mass	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Blood and lymphatic system disorders Neutropenia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Gastric fistula	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.02% 5/21587 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Acute left ventricular failure	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Internal hernia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Intestinal perforation	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Aortic valve stenosis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Atrial tachycardia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Volvulus	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Death	0.03% 7/21587 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.04% 4/10793 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Immune system disorders Drug hypersensitivity	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Cardiomyopathy	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Bacteraemia	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Balanitis candida	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Complicated appendicitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Device related sepsis	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Epididymitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Gangrene	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Hypertensive heart disease	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Gastroenteritis shigella	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Gastroenteritis viral	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Gastrointestinal infection	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Infected skin ulcer	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Monkeypox	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Otitis externa	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Staphylococcal infection	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Staphylococcal sepsis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Torsade de pointes	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Cartilage injury	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Cervical vertebral fracture	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Colon injury	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Comminuted fracture	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Concussion	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Contusion	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Facial bones fracture	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Fall	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Femoral neck fracture	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Femur fracture	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.06% 6/10793 • Number of events 6 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Fibula fracture	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Foot fracture	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Ventricular fibrillation	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Forearm fracture	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Fracture displacement	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Gun shot wound	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Ventricular tachycardia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Head injury	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Hip fracture	0.03% 6/21587 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.04% 4/10793 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Humerus fracture	0.01% 2/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Hypobarism	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Ilium fracture	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Incarcerated incisional hernia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Incision site haematoma	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Incisional hernia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Injury	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Intentional overdose	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Joint dislocation	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Ligament sprain	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Limb crushing injury	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Lower limb fracture	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Medication error	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Multiple injuries	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Congenital, familial and genetic disorders Cerebral arteriovenous malformation haemorrhagic	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Osteochondral fracture	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Overdose	0.02% 5/21587 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Congenital, familial and genetic disorders Cerebral cavernous malformation	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Patella fracture	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Pelvic fracture	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Pneumothorax traumatic	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Congenital, familial and genetic disorders Cerebral palsy	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 1/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Post procedural swelling	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Postoperative ileus	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Procedural complication	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Procedural intestinal perforation	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Radius fracture	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Reactive gastropathy	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Rib fracture	0.03% 6/21587 • Number of events 6 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Road traffic accident	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Skin laceration	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Soft tissue injury	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Spinal cord injury	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Spinal fracture	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Stab wound	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Subdural haematoma	0.01% 3/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Tendon injury	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Tendon rupture	0.02% 4/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Tibia fracture	0.02% 4/21587 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Traumatic haemothorax	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Traumatic intracranial haematoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Traumatic liver injury	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Wrist fracture	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Investigations Anticoagulation drug level above therapeutic	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Congenital, familial and genetic disorders Haemorrhagic arteriovenous malformation	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Blood and lymphatic system disorders Hypercoagulation	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Congenital, familial and genetic disorders Hamartoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Investigations Catheterisation cardiac	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Investigations Fibrin D dimer increased	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Investigations Heart rate increased	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Investigations Hepatic enzyme increased	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Investigations Oxygen saturation decreased	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Investigations Precancerous cells present	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Congenital, familial and genetic disorders Multiple congenital abnormalities	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Dehydration	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.03% 7/21587 • Number of events 8 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.04% 4/10793 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Failure to thrive	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Gout	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Hypercalcaemia	0.02% 4/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Hyperkalaemia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Hypokalaemia	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Hyponatraemia	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.04% 4/10793 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Congenital, familial and genetic disorders Renal aplasia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Obesity	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Arthralgia	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Arthritis	0.02% 5/21587 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Back pain	0.02% 4/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Congenital, familial and genetic disorders Thalassaemia minor	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Costochondritis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.01% 3/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.02% 5/21587 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.04% 4/10793 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Limb mass	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.03% 6/21587 • Number of events 6 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Ear and labyrinth disorders Deafness	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.06% 14/21587 • Number of events 16 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.09% 10/10793 • Number of events 13 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.02% 5/21587 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Ear and labyrinth disorders Deafness unilateral	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Spinal stenosis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Spinal synovial cyst	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acral lentiginous melanoma	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute monocytic leukaemia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.03% 7/21587 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.01% 3/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.01% 2/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Borderline mucinous tumour of ovary	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.05% 11/21587 • Number of events 11 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.06% 7/10793 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer male	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cerebral haemangioma	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage IV	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroid melanoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage III	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage IV	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ductal adenocarcinoma of pancreas	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ependymoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular thyroid cancer	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of bone	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hormone receptor positive breast cancer	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Huerthle cell carcinoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary breast neoplasm	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.03% 7/21587 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.06% 13/21587 • Number of events 13 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.06% 7/10793 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.01% 2/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage III	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant anorectal neoplasm	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.04% 9/21587 • Number of events 9 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of ampulla of Vater	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of pleura	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of thymus	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant splenic neoplasm	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma benign	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mucoepidermoid carcinoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.01% 2/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Ear and labyrinth disorders Neurosensory hypoacusis	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.02% 4/21587 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma stage III	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma stage III	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma stage II	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oligodendroglioma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer metastatic	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer stage III	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma stage IV	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.03% 7/21587 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia vera	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.15% 32/21587 • Number of events 34 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.20% 22/10793 • Number of events 22 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.02% 4/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage I	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage III	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage IV	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma stage IV	0.01% 2/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Retinal melanocytoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma uterus	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seminoma	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Signet-ring cell carcinoma	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sinonasal papilloma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal cord neoplasm	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.03% 6/21587 • Number of events 6 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular seminoma (pure)	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Triple negative breast cancer	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Alcoholic seizure	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Ear and labyrinth disorders Vertigo	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Amnesia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Ear and labyrinth disorders Vertigo positional	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Bulbar palsy	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Carotid artery dissection	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Carotid artery stenosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Cerebellar stroke	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Cerebral artery occlusion	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Cerebral haemorrhage	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Cerebral infarction	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Cerebral venous thrombosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Cerebrovascular accident	0.03% 6/21587 • Number of events 6 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Chronic inflammatory demyelinating polyradiculoneuropathy	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Cognitive disorder	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Corticobasal degeneration	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Delayed myelination	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Dementia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Dementia Alzheimer's type	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Demyelinating polyneuropathy	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Dizziness	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Dysarthria	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Embolic stroke	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Focal dyscognitive seizures	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Generalised tonic-clonic seizure	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Haemorrhage intracranial	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Haemorrhagic transformation stroke	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Headache	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Hemianopia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Hemianopia homonymous	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Hemiparesis	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Hydrocephalus	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Hypoaesthesia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Internal capsule infarction	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Intracranial aneurysm	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Intraventricular haemorrhage	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Ischaemic cerebral infarction	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Ischaemic stroke	0.07% 15/21587 • Number of events 15 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.06% 7/10793 • Number of events 8 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Loss of consciousness	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Lumbar radiculopathy	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Lumbosacral radiculopathy	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Metabolic encephalopathy	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Migraine	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Endocrine disorders Goitre	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Multiple sclerosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Myasthenia gravis	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Myelomalacia	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Myelopathy	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Myoclonic epilepsy	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Neurodegenerative disorder	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Neuropathy peripheral	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Normal pressure hydrocephalus	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Paraesthesia	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Parkinson's disease	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Peripheral sensory neuropathy	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Post stroke seizure	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Presyncope	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Radiculopathy	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Sciatica	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Seizure	0.01% 2/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Sensory loss	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Spinal cord compression	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Subarachnoid haemorrhage	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Syncope	0.04% 8/21587 • Number of events 8 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.04% 4/10793 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Thalamic infarction	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Thrombotic stroke	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Toxic encephalopathy	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Transient global amnesia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Transient ischaemic attack	0.05% 10/21587 • Number of events 10 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.07% 8/10793 • Number of events 8 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.07% 15/21587 • Number of events 17 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Pregnancy, puerperium and perinatal conditions Cervical incompetence	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Endocrine disorders Hypothyroidism	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Pregnancy, puerperium and perinatal conditions Premature delivery	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Pregnancy, puerperium and perinatal conditions Premature labour	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Pregnancy, puerperium and perinatal conditions Ruptured ectopic pregnancy	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Pregnancy, puerperium and perinatal conditions Stillbirth	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Product Issues Device breakage	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Acute psychosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Affective disorder	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Alcoholism	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Anxiety	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Bipolar I disorder	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Bipolar II disorder	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Endocrine disorders Secondary adrenocortical insufficiency	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Bipolar disorder	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Completed suicide	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Delirium	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Delirium tremens	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Depression	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Depression suicidal	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Major depression	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Mania	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Mental status changes	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Post-traumatic stress disorder	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Schizoaffective disorder	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Schizophrenia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Substance abuse	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Substance-induced psychotic disorder	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Suicidal ideation	0.02% 5/21587 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.05% 5/10793 • Number of events 6 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Endocrine disorders Thyroiditis subacute	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Psychiatric disorders Suicide attempt	0.03% 7/21587 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Acute kidney injury	0.06% 13/21587 • Number of events 13 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.06% 6/10793 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Bladder outlet obstruction	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Bladder perforation	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Endocrine disorders Thyrotoxic crisis	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Chronic kidney disease	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Haematuria	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Hydronephrosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Nephrolithiasis	0.03% 6/21587 • Number of events 6 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.04% 4/10793 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Nephropathy toxic	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Nephrotic syndrome	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Pelvi-ureteric obstruction	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Renal aneurysm	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Renal failure	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Eye disorders Amaurosis fugax	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Renal mass	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Renal tubular necrosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Ureterolithiasis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Urethral caruncle	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Urinary retention	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Renal and urinary disorders Urinary tract obstruction	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Reproductive system and breast disorders Adenomyosis	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.02% 4/21587 • Number of events 6 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Reproductive system and breast disorders Breast haematoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Reproductive system and breast disorders Cervical dysplasia	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Reproductive system and breast disorders Endometriosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Reproductive system and breast disorders Female genital tract fistula	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Blood and lymphatic system disorders Anaemia	0.03% 6/21587 • Number of events 6 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Reproductive system and breast disorders Menorrhagia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Reproductive system and breast disorders Ovarian cyst	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Reproductive system and breast disorders Prostatitis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Reproductive system and breast disorders Rectocele	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.05% 11/21587 • Number of events 11 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Asthma	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.03% 6/21587 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Diaphragmatic paralysis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.01% 2/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Laryngeal leukoplakia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.02% 4/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.13% 29/21587 • Number of events 32 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.06% 7/10793 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.02% 4/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Eye disorders Endocrine ophthalmopathy	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Skin and subcutaneous tissue disorders Angioedema	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Skin and subcutaneous tissue disorders Petechiae	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Aortic aneurysm	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Aortic aneurysm rupture	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Aortic dilatation	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Aortic dissection	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Aortic stenosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Arterial haemorrhage	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Arteriosclerosis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Deep vein thrombosis	0.06% 13/21587 • Number of events 14 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Embolism	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Granulomatosis with polyangiitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Haematoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Hypertension	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Hypertensive crisis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Hypertensive emergency	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Hypotension	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.04% 4/10793 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Hypovolaemic shock	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Pelvic venous thrombosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Peripheral arterial occlusive disease	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Peripheral artery haematoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Peripheral artery occlusion	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Shock haemorrhagic	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Vascular disorders Venous thrombosis limb	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Eye disorders Optic ischaemic neuropathy	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Eye disorders Retinal artery occlusion	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Eye disorders Retinal detachment	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Eye disorders Retinal vein occlusion	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Abdominal hernia	0.01% 3/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Abdominal pain upper	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Abdominal strangulated hernia	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Abdominal wall haematoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Aphthous ulcer	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Blood and lymphatic system disorders Splenic cyst	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Chronic gastritis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Colitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Colitis ischaemic	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Blood and lymphatic system disorders Splenic haematoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Constipation	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Diarrhoea	0.01% 2/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Diverticular perforation	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Blood and lymphatic system disorders Splenic infarction	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Diverticulum intestinal	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Duodenal perforation	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Erosive oesophagitis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Femoral hernia incarcerated	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Food poisoning	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Gastric ulcer haemorrhage	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Acute coronary syndrome	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Haemorrhoids thrombosed	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Acute myocardial infarction	0.13% 27/21587 • Number of events 27 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.06% 7/10793 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Hiatus hernia	0.02% 4/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Ileus	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Inguinal hernia	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Intestinal ischaemia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Angina pectoris	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Intestinal obstruction	0.04% 9/21587 • Number of events 9 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Large intestine perforation	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Angina unstable	0.01% 2/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Obstructive pancreatitis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Arrhythmia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Oesophagitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Oesophagitis haemorrhagic	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Pancreatic failure	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Pancreatitis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Pancreatitis acute	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Pancreatitis necrotising	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Pancreatolithiasis	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Atrial fibrillation	0.10% 21/21587 • Number of events 22 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.12% 13/10793 • Number of events 13 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Peptic ulcer haemorrhage	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Pharyngo-oesophageal diverticulum	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Atrial flutter	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Rectal haemorrhage	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Small intestinal obstruction	0.06% 12/21587 • Number of events 13 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.05% 5/10793 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Small intestinal perforation	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Atrioventricular block	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Atrioventricular block complete	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Umbilical hernia	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Gastrointestinal disorders Vomiting	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Atrioventricular block second degree	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Asthenia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Catheter site haematoma	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Catheter site haemorrhage	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Chest discomfort	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Chest pain	0.03% 7/21587 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Bradycardia	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Drowning	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Brugada syndrome	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Hernia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Hypothermia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Incarcerated hernia	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Bundle branch block right	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Cardiac arrest	0.02% 5/21587 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.04% 4/10793 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Cardiac disorder	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Cardiac failure	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Multiple organ dysfunction syndrome	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Non-cardiac chest pain	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Oedema peripheral	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Cardiac failure acute	0.02% 4/21587 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Procedural failure	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Cardiac failure congestive	0.04% 9/21587 • Number of events 11 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.06% 6/10793 • Number of events 9 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Pyrexia	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Sudden cardiac death	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Swelling face	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Hepatobiliary disorders Bile duct stenosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Hepatobiliary disorders Bile duct stone	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Hepatobiliary disorders Cholangitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Hepatobiliary disorders Cholecystitis	0.04% 8/21587 • Number of events 8 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Hepatobiliary disorders Cholecystitis acute	0.04% 9/21587 • Number of events 9 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Cardiac tamponade	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Hepatobiliary disorders Cholelithiasis	0.04% 8/21587 • Number of events 8 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Hepatobiliary disorders Gallbladder polyp	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Hepatobiliary disorders Hepatitis alcoholic	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Hepatobiliary disorders Jaundice	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Hepatobiliary disorders Jaundice cholestatic	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Hepatobiliary disorders Portal vein thrombosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Immune system disorders Anaphylactic reaction	0.02% 4/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Cardio-respiratory arrest	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Immune system disorders Hypersensitivity	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Abdominal abscess	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Abdominal sepsis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Abdominal wall abscess	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Abscess limb	0.02% 4/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Anal abscess	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Appendicitis	0.13% 29/21587 • Number of events 31 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.10% 11/10793 • Number of events 11 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Appendicitis perforated	0.02% 4/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Arthritis bacterial	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Cardiopulmonary failure	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Bacterial pyelonephritis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Chronic left ventricular failure	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Bursitis infective	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations COVID-19	0.09% 20/21587 • Number of events 23 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.15% 16/10793 • Number of events 17 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations COVID-19 pneumonia	0.13% 29/21587 • Number of events 34 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.19% 21/10793 • Number of events 23 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Campylobacter colitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Cellulitis	0.05% 11/21587 • Number of events 12 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.06% 7/10793 • Number of events 8 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Blood and lymphatic system disorders Blood loss anaemia	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Congestive cardiomyopathy	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Cholecystitis infective	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Chronic sinusitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Clostridium difficile colitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Clostridium difficile infection	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Coccidioidomycosis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Colonic abscess	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Coronary artery disease	0.12% 25/21587 • Number of events 26 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.05% 5/10793 • Number of events 7 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Coronavirus infection	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Cystitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Coronary artery dissection	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Device related infection	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Diverticulitis	0.03% 7/21587 • Number of events 9 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Diverticulitis intestinal perforated	0.01% 3/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Encephalitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Coronary artery occlusion	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Enterobacter sepsis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Enterococcal bacteraemia	0.01% 3/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Enterococcal sepsis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Coronary artery stenosis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Escherichia bacteraemia	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Escherichia pyelonephritis	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Escherichia urinary tract infection	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Extradural abscess	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Focal peritonitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Gastroenteritis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Giardiasis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Infective tenosynovitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Influenza	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Mitral valve incompetence	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Intervertebral discitis	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Kidney infection	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Labyrinthitis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Large intestine infection	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Localised infection	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Mitral valve prolapse	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Myocardial infarction	0.06% 12/21587 • Number of events 12 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.09% 10/10793 • Number of events 10 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Myocardial ischaemia	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Orchitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Oropharyngeal candidiasis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Osteomyelitis	0.02% 5/21587 • Number of events 6 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.05% 5/10793 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Myocarditis	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Parainfluenzae virus infection	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Pelvic abscess	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Periorbital cellulitis	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Perirectal abscess	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Myxomatous mitral valve degeneration	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Peritonitis	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Peritonsillar abscess	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Pharyngitis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Pneumonia	0.15% 32/21587 • Number of events 36 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.07% 8/10793 • Number of events 9 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Pneumonia bacterial	0.02% 5/21587 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Pneumonia klebsiella	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Non-obstructive cardiomyopathy	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Pneumonia legionella	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Pneumonia streptococcal	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Post procedural infection	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Postoperative abscess	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Postoperative wound infection	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Palpitations	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Pseudomonal sepsis	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Psoas abscess	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Pyelonephritis	0.02% 5/21587 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Pyelonephritis acute	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Pericardial effusion	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Renal cyst infection	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Respiratory syncytial virus infection	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations SARS-CoV-2 sepsis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Pericarditis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Salmonellosis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Scrotal cellulitis	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Sepsis	0.05% 11/21587 • Number of events 11 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Sepsis syndrome	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Septic shock	0.02% 5/21587 • Number of events 5 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Sinusitis bacterial	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Staphylococcal bacteraemia	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Right ventricular failure	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Streptococcal bacteraemia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Suspected COVID-19	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Sinus bradycardia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Toxic shock syndrome staphylococcal	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Tubo-ovarian abscess	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Sinus node dysfunction	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Urinary tract infection	0.04% 8/21587 • Number of events 9 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Urinary tract infection bacterial	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Urinary tract infection enterococcal	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Urosepsis	0.01% 3/21587 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Vascular device infection	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Viral infection	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations Viral pericarditis	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations West Nile viral infection	0.00% 1/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Accident	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Accidental overdose	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Supraventricular tachycardia	0.02% 4/21587 • Number of events 4 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.02% 2/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Acquired encephalocele	0.00% 0/21587 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Ankle fracture	0.03% 6/21587 • Number of events 6 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.03% 3/10793 • Number of events 3 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Aortic injury	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Cardiac disorders Tachycardia	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.01% 1/10793 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Bladder injury	0.00% 1/21587 • Number of events 1 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Injury, poisoning and procedural complications Burns second degree	0.01% 2/21587 • Number of events 2 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.00% 0/10793 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).

Other adverse events

Measure	AZD1222 n=21587 participants at risk Participants received 2 IM doses of 5\*10\^10 vp (nominal, ± 1.5\*10\^10 vp) AZD1222 on Days 1 and 29.	Placebo n=10793 participants at risk Participants received 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
Musculoskeletal and connective tissue disorders Myalgia	7.5% 1622/21587 • Number of events 1736 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	2.6% 278/10793 • Number of events 296 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Nervous system disorders Headache	16.3% 3511/21587 • Number of events 4106 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	9.2% 996/10793 • Number of events 1125 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Chills	10.2% 2208/21587 • Number of events 2366 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	2.3% 248/10793 • Number of events 264 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Fatigue	13.1% 2836/21587 • Number of events 3250 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	7.9% 853/10793 • Number of events 942 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Injection site pain	16.8% 3624/21587 • Number of events 4363 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	4.9% 532/10793 • Number of events 595 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Pain	8.6% 1857/21587 • Number of events 2023 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	2.4% 264/10793 • Number of events 283 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
General disorders Pyrexia	5.4% 1174/21587 • Number of events 1209 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	0.68% 73/10793 • Number of events 78 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
Infections and infestations COVID-19	28.8% 6207/21587 • Number of events 6717 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).	25.2% 2715/10793 • Number of events 2921 • For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days. The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

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