Trial Outcomes & Findings for Transfusion Trigger After Operations in High Cardiac Risk Patients (NCT NCT03229941)

NCT ID: NCT03229941

Last Updated: 2025-11-21

Results Overview

MI will be defined using the Third Universal Definition of Myocardial Infarction. Acute renal failure will be defined as Acute Kidney Injury stage III according to RIFLE criteria. Baseline creatinine will be considered the creatinine upon admission prior to the index operation. The above urine output criteria will be only used for patients who are in the ICU and have precise monitoring of their urinary output. For patients on the surgical floor only serum creatinine changes will be used for assessment of this endpoint. Coronary revascularization will be defined as a coronary artery bypass graft, or percutaneous coronary intervention (either angioplasty or stenting). Stroke will be defined as new unilateral neurological deficit that lasts for more than 24 hours, and is confirmed by a brain imaging modality (computed tomography or magnetic resonance imaging study) demonstrating new brain infarct.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1424 participants
• Primary outcome timeframe: 90 days after randomization
• Results posted on: 2025-11-21

Participant Flow

Participant milestones

Measure	Restrictive Blood transfusion trigger: Hb\<7gm/dl	Liberal Blood transfusion trigger: Hb\<10gm/dl
Overall Study STARTED	712	712
Overall Study COMPLETED	667	636
Overall Study NOT COMPLETED	45	76

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transfusion Trigger After Operations in High Cardiac Risk Patients

Baseline characteristics by cohort

Measure	Restrictive n=712 Participants Blood transfusion trigger: Hb\<7gm/dl	Liberal n=712 Participants Blood transfusion trigger: Hb\<10gm/dl	Total n=1424 Participants Total of all reporting groups
Age, Continuous	70.2 years STANDARD_DEVIATION 7.71 • n=68 Participants	69.7 years STANDARD_DEVIATION 8.15 • n=76 Participants	69.9 years STANDARD_DEVIATION 7.93 • n=48 Participants
Sex: Female, Male Female	9 Participants n=68 Participants	22 Participants n=76 Participants	31 Participants n=48 Participants
Sex: Female, Male Male	703 Participants n=68 Participants	690 Participants n=76 Participants	1393 Participants n=48 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=68 Participants	25 Participants n=76 Participants	58 Participants n=48 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	663 Participants n=68 Participants	667 Participants n=76 Participants	1330 Participants n=48 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=68 Participants	20 Participants n=76 Participants	36 Participants n=48 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=68 Participants	13 Participants n=76 Participants	21 Participants n=48 Participants
Race (NIH/OMB) Asian	2 Participants n=68 Participants	1 Participants n=76 Participants	3 Participants n=48 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	5 Participants n=68 Participants	5 Participants n=76 Participants	10 Participants n=48 Participants
Race (NIH/OMB) Black or African American	125 Participants n=68 Participants	143 Participants n=76 Participants	268 Participants n=48 Participants
Race (NIH/OMB) White	548 Participants n=68 Participants	522 Participants n=76 Participants	1070 Participants n=48 Participants
Race (NIH/OMB) More than one race	6 Participants n=68 Participants	4 Participants n=76 Participants	10 Participants n=48 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=68 Participants	24 Participants n=76 Participants	42 Participants n=48 Participants

PRIMARY outcome

Timeframe: 90 days after randomization

Population: Intent to treat population

MI will be defined using the Third Universal Definition of Myocardial Infarction. Acute renal failure will be defined as Acute Kidney Injury stage III according to RIFLE criteria. Baseline creatinine will be considered the creatinine upon admission prior to the index operation. The above urine output criteria will be only used for patients who are in the ICU and have precise monitoring of their urinary output. For patients on the surgical floor only serum creatinine changes will be used for assessment of this endpoint. Coronary revascularization will be defined as a coronary artery bypass graft, or percutaneous coronary intervention (either angioplasty or stenting). Stroke will be defined as new unilateral neurological deficit that lasts for more than 24 hours, and is confirmed by a brain imaging modality (computed tomography or magnetic resonance imaging study) demonstrating new brain infarct.

Outcome measures

Measure	Restrictive n=700 Participants Blood transfusion trigger: Hb\<7gm/dl	Liberal n=670 Participants Blood transfusion trigger: Hb\<10gm/dl
A Composite Endpoint of All-cause Post-randomization Mortality, Myocardial Infarction (MI), Coronary Revascularization, Acute Renal Failure, or Post-randomization Ischemic Stroke up to 90 Days After Randomization	71 Participants	61 Participants

SECONDARY outcome

Timeframe: 90 days after randomization

Population: Intent to treat population

Wound infection will be defined according to the Centers for Disease Control and Prevention (CDC) guidelines as a) positive wound culture, or b) drainage of pus from a wound, or c) suspicion of wound infection that was drained operatively.

Pneumonia will be defined according to the CDC definition as chest radiograph with new or progressive infiltrate, consolidation, cavitation, or pleural effusion and any of the following: new onset of purulent sputum or change in character of sputum, or organism isolated from blood culture, trans-tracheal aspirate, bronchial brushings, or biopsy.

Sepsis will be defined as a combination of two of the following systemic inflammatory response syndrome (SIRS) criteria, plus suspected or present source of infection. SIRS criteria will include the following: temperature greater than 38C, heart rate greater than 90 beats/min, WBC > 12,000 or < 4,000, or > 10% bands.

Outcome measures

Measure	Restrictive n=679 Participants Blood transfusion trigger: Hb\<7gm/dl	Liberal n=652 Participants Blood transfusion trigger: Hb\<10gm/dl
A Composite Endpoint of Postoperative Infectious Complications at 90 Days Post-randomization: Infectious Complications Will Include Wound Infections, Pneumonia, and Sepsis	100 Participants	103 Participants

SECONDARY outcome

Timeframe: 90 days after randomization

Population: Intent to treat population

The diagnosis of cardiac arrhythmias will be based on EKG findings. Only arrhythmias that result in initiation of new treatment regimen (to include medications, implantable devices, or surgical intervention) during hospitalization will be recorded.

CHF will require at least one of the following symptoms or signs new or worsening: dyspnea at rest, orthopnea, or paroxysmal nocturnal dyspnea and radiological evidence of heart failure or worsening heart failure and increase/initiation of established treatment.

Cardiac arrest will be defined as the cessation of cardiac pump function activity that results in loss of consciousness and absence of circulating blood flow as evidenced by absent carotid pulse. Only episodes of cardiac arrest that are reversed will be collected under this endpoint. If they are not reversed the event will be categorized as death.

Outcome measures

Measure	Restrictive n=678 Participants Blood transfusion trigger: Hb\<7gm/dl	Liberal n=647 Participants Blood transfusion trigger: Hb\<10gm/dl
A Composite Endpoint of Cardiac Complications (Other Than MI) at 90 Days Post-randomization: Cardiac Complications Include New Cardiac Arrhythmias That Necessitate New Treatment, New or Worsening Congestive Heart Failure, and Non Fatal Cardiac Arrest	67 Participants	38 Participants

SECONDARY outcome

Timeframe: 12 months after randomization

Population: Intent to treat population

The investigators will determine vital status by telephoning participants after hospital discharge, by searching the electronic medical record and the Death Ascertainment File.

Outcome measures

Measure	Restrictive n=701 Participants Blood transfusion trigger: Hb\<7gm/dl	Liberal n=668 Participants Blood transfusion trigger: Hb\<10gm/dl
All-cause Mortality at 1 Year After Randomization	105 Participants	94 Participants

SECONDARY outcome

Timeframe: 30 days after randomization

Population: Intent to treat population

A composite endpoint of all-cause mortality, MI, coronary revascularization, acute renal failure, or postoperative ischemic stroke.

Outcome measures

Measure	Restrictive n=703 Participants Blood transfusion trigger: Hb\<7gm/dl	Liberal n=680 Participants Blood transfusion trigger: Hb\<10gm/dl
A Composite Endpoint of All-cause Mortality, MI, Coronary Revascularization, Acute Renal Failure, or Postoperative Ischemic Stroke	45 Participants	33 Participants

SECONDARY outcome

Timeframe: At hospital discharge, up to 1 year

Population: Intent to Treat population

Length of hospital stay.

Outcome measures

Measure	Restrictive n=709 Participants Blood transfusion trigger: Hb\<7gm/dl	Liberal n=695 Participants Blood transfusion trigger: Hb\<10gm/dl
Length of Hospital Stay	5.0 days Interval 3.0 to 8.0	5.0 days Interval 3.0 to 8.0

Adverse Events

Restrictive

Serious events: 386 serious events

Other events: 0 other events

Deaths: 105 deaths

Liberal

Serious events: 372 serious events

Other events: 0 other events

Deaths: 94 deaths

Serious adverse events

Measure	Restrictive n=712 participants at risk Blood transfusion trigger: Hb\<7gm/dl	Liberal n=712 participants at risk Blood transfusion trigger: Hb\<10gm/dl
Blood and lymphatic system disorders Anaemia	2.1% 15/712 • Number of events 15 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.84% 6/712 • Number of events 6 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Blood and lymphatic system disorders Febrile neutropenia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Blood and lymphatic system disorders Iron deficiency anaemia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Blood and lymphatic system disorders Leukocytosis	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Angina pectoris	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Aortic valve stenosis	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Arrhythmia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Atrial fibrillation	3.4% 24/712 • Number of events 26 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	1.7% 12/712 • Number of events 12 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Atrial flutter	0.56% 4/712 • Number of events 6 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Atrioventricular block	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Atrioventricular block complete	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Atrioventricular block second degree	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Bradycardia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Cardiac arrest	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.84% 6/712 • Number of events 6 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Cardiac failure congestive	5.9% 42/712 • Number of events 48 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	3.7% 26/712 • Number of events 29 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Cardiogenic shock	0.28% 2/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Coronary artery disease	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Hypervolaemia	0.84% 6/712 • Number of events 6 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.84% 6/712 • Number of events 6 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Myocardial infarction	4.8% 34/712 • Number of events 35 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	4.2% 30/712 • Number of events 31 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Myocardial ischaemia	0.98% 7/712 • Number of events 7 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Sinus node dysfunction	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Sinus tachycardia	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Supraventricular tachycardia	0.14% 1/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Tachyarrhythmia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Tachycardia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Tachycardia paroxysmal	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Ventricular extrasystoles	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Cardiac disorders Ventricular tachycardia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Endocrine disorders Adrenal insufficiency	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Endocrine disorders Hypothyroidism	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Abdominal distension	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Abdominal pain	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Abdominal wall haematoma	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Anal incontinence	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Colitis ischaemic	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Constipation	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Duodenal perforation	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Dysphagia	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Enterocolitis	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Gastric perforation	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.4% 17/712 • Number of events 18 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	2.7% 19/712 • Number of events 19 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Gastrointestinal necrosis	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Haematemesis	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Haematochezia	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Ileus	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Inguinal hernia	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Intestinal mass	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Irritable bowel syndrome	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Melaena	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Nausea	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Oesophagitis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Pancreatic mass	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Peptic ulcer	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Small intestinal haemorrhage	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Small intestinal obstruction	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Gastrointestinal disorders Vomiting	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
General disorders Asthenia	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
General disorders Cardiac death	1.3% 9/712 • Number of events 9 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.84% 6/712 • Number of events 6 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
General disorders Catheter site haematoma	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
General disorders Chest discomfort	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
General disorders Chest pain	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
General disorders Cyst	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
General disorders Death	0.98% 7/712 • Number of events 7 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
General disorders Impaired healing	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
General disorders Multiple organ dysfunction syndrome	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
General disorders Oedema peripheral	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
General disorders Pyrexia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
General disorders Vascular stent thrombosis	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Hepatobiliary disorders Biliary colic	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Hepatobiliary disorders Cholecystitis	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Hepatobiliary disorders Cirrhosis alcoholic	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Hepatobiliary disorders Hepatic failure	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Hepatobiliary disorders Hypertransaminasaemia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Abscess	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Arthritis bacterial	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Bacteraemia	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Bronchitis bacterial	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations COVID-19	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.70% 5/712 • Number of events 5 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations COVID-19 pneumonia	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Cellulitis	2.0% 14/712 • Number of events 15 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	1.8% 13/712 • Number of events 14 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Clostridium difficile colitis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Clostridium difficile infection	1.3% 9/712 • Number of events 9 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.70% 5/712 • Number of events 5 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Diabetic foot infection	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Diverticulitis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Endocarditis	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Epididymitis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Fungal infection	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Fungal oesophagitis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Gangrene	1.3% 9/712 • Number of events 9 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	1.3% 9/712 • Number of events 9 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Groin infection	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Herpes zoster	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Incision site cellulitis	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Infected seroma	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Infected skin ulcer	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Infectious pleural effusion	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Infective aneurysm	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Influenza	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Localised infection	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Necrotising fasciitis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Osteomyelitis	1.5% 11/712 • Number of events 12 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	1.7% 12/712 • Number of events 12 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Pelvic abscess	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Penile infection	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Pneumonia	2.7% 19/712 • Number of events 19 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	2.7% 19/712 • Number of events 19 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Pneumonia aspiration	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Post procedural cellulitis	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Postoperative abscess	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Postoperative wound infection	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Prosthetic valve endocarditis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Pyelonephritis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Respiratory tract infection	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Scrotal abscess	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Scrotal cellulitis	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Sepsis	3.5% 25/712 • Number of events 25 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	4.6% 33/712 • Number of events 35 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Septic pulmonary embolism	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Septic shock	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Sinusitis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Splenic abscess	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Upper respiratory tract infection	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Urinary tract infection	1.4% 10/712 • Number of events 10 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	2.1% 15/712 • Number of events 16 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Vascular device infection	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Vascular graft infection	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Wound infection	10.7% 76/712 • Number of events 82 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	10.0% 71/712 • Number of events 78 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Infections and infestations Wound infection bacterial	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Accidental overdose	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Anastomotic haemorrhage	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Anastomotic leak	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Anastomotic ulcer haemorrhage	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Cystitis radiation	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Exposure to SARS-CoV-2	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Fall	0.56% 4/712 • Number of events 5 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Fracture	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Graft thrombosis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Incision site haematoma	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Incision site haemorrhage	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Incision site impaired healing	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Incision site ulcer	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Limb injury	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Lisfranc fracture	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Mental status changes postoperative	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Pancreatic leak	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Peripheral arterial reocclusion	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Post procedural fever	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Post procedural haematoma	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	2.0% 14/712 • Number of events 14 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Post procedural oedema	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Postoperative delirium	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Postoperative wound complication	0.70% 5/712 • Number of events 6 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Procedural pain	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Rotator cuff syndrome	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Seroma	0.70% 5/712 • Number of events 5 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.84% 6/712 • Number of events 6 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Toxicity to various agents	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Vascular graft complication	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Vascular graft occlusion	1.3% 9/712 • Number of events 9 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.84% 6/712 • Number of events 6 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Vascular graft stenosis	0.98% 7/712 • Number of events 7 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Vascular graft thrombosis	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.70% 5/712 • Number of events 5 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Wound complication	2.0% 14/712 • Number of events 16 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	3.1% 22/712 • Number of events 22 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Wound dehiscence	1.7% 12/712 • Number of events 12 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	1.5% 11/712 • Number of events 12 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Wound haematoma	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Wound haemorrhage	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Injury, poisoning and procedural complications Wound necrosis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Angiocardiogram	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Angiogram peripheral	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Ankle brachial index decreased	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Anticoagulation drug level below therapeutic	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Blood creatinine increased	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Blood pressure increased	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Cardiac pacemaker evaluation	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Catheterisation cardiac	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Colonoscopy	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Electrocardiogram ST segment abnormal	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Hepatic enzyme increased	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Myocardial necrosis marker increased	0.70% 5/712 • Number of events 5 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Oxygen consumption increased	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations Troponin increased	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.84% 6/712 • Number of events 6 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Investigations White blood cell count increased	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Metabolism and nutrition disorders Calciphylaxis	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Metabolism and nutrition disorders Dehydration	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Metabolism and nutrition disorders Diabetes mellitus	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Metabolism and nutrition disorders Failure to thrive	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Metabolism and nutrition disorders Hypercalcaemia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Metabolism and nutrition disorders Hyperkalaemia	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Metabolism and nutrition disorders Hypernatraemia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Metabolism and nutrition disorders Hypoglycaemia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Metabolism and nutrition disorders Hyponatraemia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Metabolism and nutrition disorders Hypovolaemia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Metabolism and nutrition disorders Malnutrition	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Musculoskeletal and connective tissue disorders Pain in extremity	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Altered state of consciousness	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Ataxia	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Brain injury	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Cerebrovascular accident	1.1% 8/712 • Number of events 8 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.98% 7/712 • Number of events 7 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Dizziness postural	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Encephalopathy	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Headache	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Loss of consciousness	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Metabolic encephalopathy	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Myelopathy	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Neuralgia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Presyncope	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Seizure	0.56% 4/712 • Number of events 6 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Spinal cord ischaemia	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Syncope	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Toxic encephalopathy	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Nervous system disorders Transient ischaemic attack	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Product Issues Device occlusion	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Psychiatric disorders Anxiety	0.14% 1/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Psychiatric disorders Delirium	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Psychiatric disorders Mental status changes	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Psychiatric disorders Suicidal ideation	0.42% 3/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Renal and urinary disorders Acute kidney injury	4.5% 32/712 • Number of events 34 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	4.6% 33/712 • Number of events 37 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Renal and urinary disorders Bladder outlet obstruction	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Renal and urinary disorders End stage renal disease	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Renal and urinary disorders Glomerulonephritis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Renal and urinary disorders Haematuria	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Renal and urinary disorders Hydronephrosis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Renal and urinary disorders Renal artery stenosis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Renal and urinary disorders Renal haemorrhage	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Renal and urinary disorders Urinary retention	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Renal and urinary disorders Urinary tract obstruction	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Reproductive system and breast disorders Scrotal swelling	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.5% 11/712 • Number of events 12 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	1.4% 10/712 • Number of events 11 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Skin and subcutaneous tissue disorders Ischaemic skin ulcer	0.14% 1/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Skin and subcutaneous tissue disorders Skin ulcer	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Social circumstances Prosthesis user	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Debridement	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Social circumstances Social stay hospitalisation	0.70% 5/712 • Number of events 5 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.98% 7/712 • Number of events 7 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Alcohol detoxification	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Amputation	1.1% 8/712 • Number of events 8 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	1.3% 9/712 • Number of events 9 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Aneurysm repair	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Anticoagulant therapy	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Aortic aneurysm repair	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Arterial repair	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Arterial stent insertion	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Arteriovenous fistula operation	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Cardiac ablation	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Cataract operation	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Catheter directed thrombolysis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Coronary artery bypass	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Coronary revascularisation	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Fasciotomy	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Foot amputation	0.70% 5/712 • Number of events 5 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.70% 5/712 • Number of events 5 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Gastrointestinal tube insertion	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Gastrostomy	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Hernia repair	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Hospitalisation	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Implantable defibrillator insertion	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Jejunostomy	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Leg amputation	2.4% 17/712 • Number of events 18 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	2.8% 20/712 • Number of events 20 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Nephrostomy	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Percutaneous coronary intervention	0.98% 7/712 • Number of events 7 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.70% 5/712 • Number of events 5 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Peripheral artery angioplasty	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Peripheral artery bypass	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Peripheral revascularisation	0.56% 4/712 • Number of events 4 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Plastic surgery of the lips and mouth	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Post procedural drainage	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Skin graft	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Spinal fusion surgery	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Spinal laminectomy	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Thrombectomy	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Toe amputation	1.3% 9/712 • Number of events 9 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.84% 6/712 • Number of events 6 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Tracheostomy	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Transurethral bladder resection	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Vascular graft	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Surgical and medical procedures Wound closure	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Aneurysm	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Aortic aneurysm	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Aortic occlusion	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Aortic stenosis	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Atheroembolism	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Blue toe syndrome	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Deep vein thrombosis	1.1% 8/712 • Number of events 8 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Haematoma	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Haemorrhage	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Hypertension	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Hypertensive emergency	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Hypertensive urgency	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Hypotension	2.0% 14/712 • Number of events 14 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Hypovolaemic shock	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Iliac artery occlusion	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Lymphocele	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Lymphorrhoea	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Peripheral arterial occlusive disease	0.98% 7/712 • Number of events 7 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.98% 7/712 • Number of events 7 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Peripheral artery occlusion	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.42% 3/712 • Number of events 3 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Peripheral artery stenosis	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Peripheral artery thrombosis	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Peripheral ischaemia	1.1% 8/712 • Number of events 8 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.98% 7/712 • Number of events 7 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Peripheral vascular disorder	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Shock	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Shock haemorrhagic	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.28% 2/712 • Number of events 2 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Steal syndrome	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.
Vascular disorders Thrombosis	0.14% 1/712 • Number of events 1 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.	0.00% 0/712 • All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected All SAEs were assessed up to the last contact during the active follow-up of the study and includes all participants who were followed for about 90 days during the study. All-cause mortality was assessed for up to 12 months after randomization. Other (i.e., those that were not serious) Adverse Events were not monitored/assessed within this study and hence the number at risk is zero for both arms.

Other adverse events

Adverse event data not reported

Additional Information

Panagiotis Kougias

New York Veterans Affairs Healthcare System, Brooklyn

Phone: 718-836-6600

Email: panagiotis.kougias@va.gov

Results disclosure agreements

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