Trial Outcomes & Findings for WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2 (NCT NCT03302494)

NCT ID: NCT03302494

Last Updated: 2025-03-12

Results Overview

The primary safety outcome was the composite of death from any cause (all-cause mortality), procedure or device related complications requiring percutaneous or surgical intervention through 45 days post procedure or major bleeding throughout the duration of the trial. The analysis was based on sponsor assessment of adverse events data. Baseline was defined as 90 day prior to treatment or 90 days prior to randomization; baseline assessments could occur on the day of implant.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 248 participants
• Primary outcome timeframe: All death, procedure- or device-related complications requiring percutaneous or surgical intervention: From baseline up to 45 days; major bleeding: From baseline up to 5 years 11 months
• Results posted on: 2025-03-12

Participant Flow

Analysis population included participants greater than or equal to (>=) 18 years old diagnosed with non-valvular atrial fibrillation and a CHADS2 score >= 2 or a CHA2DS2-VASc score >= 3 who had an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation.

As pre-specified in the protocol, participants who signed the informed consent form (ICF) were considered enrolled in the study. Out of the 248 enrolled participants (who signed the ICF), 183 were randomized to respective treatment arms, 26 were screen failures and 39 discontinued due to study hold during the screening period. Hence, data for 183 randomized participants is reported below.

Participant milestones

Measure	Group 1 (WaveCrest Roll-In) Roll in participants who were enrolled prior to a site's randomization phase and who had vascular access attempted, underwent Coherex WaveCrest left atrial appendage (LAA) occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.	Group 2 (WaveCrest Randomized) Randomized participants underwent Coherex WaveCrest LAA occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a trans septal puncture into the LAA.	Group 3 (Watchman Randomized) Randomized participants underwent Watchman left atrial appendage closure (LAAC) System (Watchman Device) implant procedure. Watchman device was intended for percutaneous, transcatheter closure of the left atrial appendage and consisted of the watchman access system (access sheath and dilator) and watchman delivery system (delivery catheter and watchman device). The access sheath and delivery catheter permitted device placement in the LAA via femoral venous access and inter-atrial septum crossing into the left atrium.
Overall Study STARTED	71	54	58
Overall Study Treated	71	52	56
Overall Study COMPLETED	6	1	3
Overall Study NOT COMPLETED	65	53	55

Reasons for withdrawal

Measure	Group 1 (WaveCrest Roll-In) Roll in participants who were enrolled prior to a site's randomization phase and who had vascular access attempted, underwent Coherex WaveCrest left atrial appendage (LAA) occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.	Group 2 (WaveCrest Randomized) Randomized participants underwent Coherex WaveCrest LAA occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a trans septal puncture into the LAA.	Group 3 (Watchman Randomized) Randomized participants underwent Watchman left atrial appendage closure (LAAC) System (Watchman Device) implant procedure. Watchman device was intended for percutaneous, transcatheter closure of the left atrial appendage and consisted of the watchman access system (access sheath and dilator) and watchman delivery system (delivery catheter and watchman device). The access sheath and delivery catheter permitted device placement in the LAA via femoral venous access and inter-atrial septum crossing into the left atrium.
Overall Study Other	7	4	6
Overall Study Withdrawal by Subject	10	2	9
Overall Study Study Terminated by Sponsor	32	29	30
Overall Study Physician Decision	1	0	1
Overall Study Lost to Follow-up	1	3	3
Overall Study Death	13	11	4
Overall Study Adverse Event	1	2	0
Overall Study Randomized but not treated and discontinued during study hold	0	2	2

Baseline Characteristics

WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2

Baseline characteristics by cohort

Measure	Group 1 (WaveCrest Roll-In) n=71 Participants Roll in participants who were enrolled prior to a site's randomization phase and who had vascular access attempted, underwent Coherex WaveCrest left atrial appendage (LAA) occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.	Group 2 (WaveCrest Randomized) n=52 Participants Randomized participants underwent Coherex WaveCrest LAA occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a trans septal puncture into the LAA.	Group 3 (Watchman Randomized) n=56 Participants Randomized participants underwent Watchman left atrial appendage closure (LAAC) System (Watchman Device) implant procedure. Watchman device was intended for percutaneous, transcatheter closure of the left atrial appendage and consisted of the watchman access system (access sheath and dilator) and watchman delivery system (delivery catheter and watchman device). The access sheath and delivery catheter permitted device placement in the LAA via femoral venous access and inter-atrial septum crossing into the left atrium.	Total n=179 Participants Total of all reporting groups
Age, Continuous	72.0 years STANDARD_DEVIATION 9.64 • n=5 Participants	75.9 years STANDARD_DEVIATION 6.43 • n=7 Participants	76.0 years STANDARD_DEVIATION 5.69 • n=5 Participants	74.4 years STANDARD_DEVIATION 7.88 • n=4 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	73 Participants n=4 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	31 Participants n=7 Participants	36 Participants n=5 Participants	106 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized White	69 Participants n=5 Participants	51 Participants n=7 Participants	53 Participants n=5 Participants	173 Participants n=4 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: All death, procedure- or device-related complications requiring percutaneous or surgical intervention: From baseline up to 45 days; major bleeding: From baseline up to 5 years 11 months

Population: The intention-to-treat (ITT) analysis set consisted of all randomized participants regardless of treatment received.

The primary safety outcome was the composite of death from any cause (all-cause mortality), procedure or device related complications requiring percutaneous or surgical intervention through 45 days post procedure or major bleeding throughout the duration of the trial. The analysis was based on sponsor assessment of adverse events data. Baseline was defined as 90 day prior to treatment or 90 days prior to randomization; baseline assessments could occur on the day of implant.

Outcome measures

Measure	Group 1 (WaveCrest Roll-In) n=71 Participants Roll in participants who were enrolled prior to a site's randomization phase and who had vascular access attempted, underwent Coherex WaveCrest left atrial appendage (LAA) occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.	Group 2 (WaveCrest Randomized) n=52 Participants Randomized participants underwent Coherex WaveCrest LAA occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a trans septal puncture into the LAA.	Group 3 (Watchman Randomized) n=56 Participants Randomized participants underwent Watchman left atrial appendage closure (LAAC) System (Watchman Device) implant procedure. Watchman device was intended for percutaneous, transcatheter closure of the left atrial appendage and consisted of the watchman access system (access sheath and dilator) and watchman delivery system (delivery catheter and watchman device). The access sheath and delivery catheter permitted device placement in the LAA via femoral venous access and inter-atrial septum crossing into the left atrium.
Percentage of Participants With Composite of All Cause Death, Procedure or Device Related Complications Requiring Percutaneous or Surgical Intervention or Major Bleeding	47.89 Percentage of participants Interval 35.9 to 60.1	32.69 Percentage of participants Interval 20.3 to 47.1	17.86 Percentage of participants Interval 8.9 to 30.4

PRIMARY outcome

Timeframe: At 24 months

Population: The ITT analysis set consisted of all randomized participants regardless of treatment received.

Percentage of participants with composite of ischemic stroke or systemic embolism at 24 months was reported.

Outcome measures

Measure	Group 1 (WaveCrest Roll-In) n=71 Participants Roll in participants who were enrolled prior to a site's randomization phase and who had vascular access attempted, underwent Coherex WaveCrest left atrial appendage (LAA) occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.	Group 2 (WaveCrest Randomized) n=52 Participants Randomized participants underwent Coherex WaveCrest LAA occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a trans septal puncture into the LAA.	Group 3 (Watchman Randomized) n=56 Participants Randomized participants underwent Watchman left atrial appendage closure (LAAC) System (Watchman Device) implant procedure. Watchman device was intended for percutaneous, transcatheter closure of the left atrial appendage and consisted of the watchman access system (access sheath and dilator) and watchman delivery system (delivery catheter and watchman device). The access sheath and delivery catheter permitted device placement in the LAA via femoral venous access and inter-atrial septum crossing into the left atrium.
Percentage of Participants With Composite of Ischemic Stroke or Systemic Embolism at 24 Months	4.23 Percentage of participants Interval 0.9 to 11.9	3.85 Percentage of participants Interval 0.5 to 13.2	5.36 Percentage of participants Interval 1.1 to 14.9

SECONDARY outcome

Timeframe: At 45 days

Population: The ITT analysis set consisted of all randomized participants regardless of treatment received.

CHADS2 (congestive heart failure, hypertension, age >=75 years (yrs), prior Stroke/transient ischemic attack (TIA)/Thromboembolism) and CHA2DS2-VASc scores (Vascular disease, Age 65- 74 yrs, female Sex) were developed to identify non-valvular atrial fibrillation (AF) participants at an elevated risk for ischemic stroke. CHADS2 score assign 1 point: congestive heart failure, hypertension, age >= 75 yrs, diabetes mellitus; 2 points: prior stroke/TIA/thromboembolism. CHADS2 score ranges from 0 to 6. Higher scores indicated higher risk for ischemic strokes. CHA2DS2-VASc Score assign 1 point for each following risk factors: congestive heart failure, hypertension (blood pressure consistently above 140/90), diabetes mellitus, vascular disease, age 65 to74 yrs, female and assigned 2 points for age >=75 yrs and prior stroke or TIA or thromboembolism each. Overall score ranged from 0 to a 9, with lower scores indicated lower risk and higher scores indicated higher risk for ischemic strokes.

Outcome measures

Measure	Group 1 (WaveCrest Roll-In) n=71 Participants Roll in participants who were enrolled prior to a site's randomization phase and who had vascular access attempted, underwent Coherex WaveCrest left atrial appendage (LAA) occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.	Group 2 (WaveCrest Randomized) n=52 Participants Randomized participants underwent Coherex WaveCrest LAA occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a trans septal puncture into the LAA.	Group 3 (Watchman Randomized) n=56 Participants Randomized participants underwent Watchman left atrial appendage closure (LAAC) System (Watchman Device) implant procedure. Watchman device was intended for percutaneous, transcatheter closure of the left atrial appendage and consisted of the watchman access system (access sheath and dilator) and watchman delivery system (delivery catheter and watchman device). The access sheath and delivery catheter permitted device placement in the LAA via femoral venous access and inter-atrial septum crossing into the left atrium.
Percentage of Participants With Ischemic Stroke or Systemic Embolism With the WAVECREST Device in Comparison to the CHADS2 and CHA2DS2-VASc Imputed Risk of Ischemic Stroke or Systemic Embolism in the Absence of Anticoagulant Therapy ischemic strokes	4.23 Percentage of participants	3.85 Percentage of participants	5.36 Percentage of participants
Percentage of Participants With Ischemic Stroke or Systemic Embolism With the WAVECREST Device in Comparison to the CHADS2 and CHA2DS2-VASc Imputed Risk of Ischemic Stroke or Systemic Embolism in the Absence of Anticoagulant Therapy systemic embolisms	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: At 45 days

Population: Analysis population included all roll-in and randomized and treated participants. Here 'N' (number of participants analysed) signifies number of participants who were evaluable for this outcome measures.

Percentage of participants with LAA closure, defined as a gap of <= 5 millimetre (mm) at the 45-day visit as assessed by transesophageal echocardiogram (TEE) was reported.

Outcome measures

Measure	Group 1 (WaveCrest Roll-In) n=67 Participants Roll in participants who were enrolled prior to a site's randomization phase and who had vascular access attempted, underwent Coherex WaveCrest left atrial appendage (LAA) occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.	Group 2 (WaveCrest Randomized) n=50 Participants Randomized participants underwent Coherex WaveCrest LAA occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a trans septal puncture into the LAA.	Group 3 (Watchman Randomized) n=51 Participants Randomized participants underwent Watchman left atrial appendage closure (LAAC) System (Watchman Device) implant procedure. Watchman device was intended for percutaneous, transcatheter closure of the left atrial appendage and consisted of the watchman access system (access sheath and dilator) and watchman delivery system (delivery catheter and watchman device). The access sheath and delivery catheter permitted device placement in the LAA via femoral venous access and inter-atrial septum crossing into the left atrium.
Percentage of Participants With Left Atrial Appendage (LAA) Closure	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants

Adverse Events

Group 1 (WaveCrest Roll-In):

Serious events: 50 serious events

Other events: 63 other events

Deaths: 15 deaths

Group 2 (WaveCrest Randomized)

Serious events: 42 serious events

Other events: 51 other events

Deaths: 13 deaths

Group 3 (Watchman Randomized)

Serious events: 39 serious events

Other events: 48 other events

Deaths: 4 deaths

Serious adverse events

Measure	Group 1 (WaveCrest Roll-In): n=71 participants at risk Roll in participants who were enrolled prior to a site's randomization phase and who had vascular access attempted, underwent Coherex WaveCrest left atrial appendage (LAA) occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.	Group 2 (WaveCrest Randomized) n=52 participants at risk Randomized participants underwent Coherex WaveCrest LAA occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a trans septal puncture into the LAA.	Group 3 (Watchman Randomized) n=56 participants at risk Randomized participants underwent Watchman left atrial appendage closure (LAAC) System (Watchman Device) implant procedure. Watchman device was intended for percutaneous, transcatheter closure of the left atrial appendage and consisted of the watchman access system (access sheath and dilator) and watchman delivery system (delivery catheter and watchman device). The access sheath and delivery catheter permitted device placement in the LAA via femoral venous access and inter-atrial septum crossing into the left atrium.
Blood and lymphatic system disorders Anaemia	9.9% 7/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.4% 3/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Blood and lymphatic system disorders Febrile neutropenia	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Blood and lymphatic system disorders Iron deficiency anaemia	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.8% 3/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Blood and lymphatic system disorders Leukocytosis	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Blood and lymphatic system disorders Microcytic anaemia	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Blood and lymphatic system disorders Splenic lesion	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Blood and lymphatic system disorders Thrombocytopenia	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Acute left ventricular failure	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.4% 3/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Acute myocardial infarction	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.4% 3/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Angina pectoris	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Angina unstable	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Aortic valve stenosis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Atrial fibrillation	15.5% 11/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	13.5% 7/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	8.9% 5/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Atrioventricular block second degree	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Bradycardia	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Cardiac arrest	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Cardiac failure	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Cardiac failure acute	5.6% 4/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.1% 4/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Cardiac failure congestive	8.5% 6/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	11.5% 6/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	10.7% 6/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Cardiac tamponade	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Cardiogenic shock	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Cardiomyopathy	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Chronic left ventricular failure	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Coronary artery disease	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Mitral valve disease	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Mitral valve incompetence	5.6% 4/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Pericardial effusion	12.7% 9/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Pericarditis	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Sinus node dysfunction	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Supraventricular tachycardia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Tachycardia	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Ventricular tachycardia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Congenital, familial and genetic disorders Haemorrhagic arteriovenous malformation	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Ear and labyrinth disorders Vertigo	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Endocrine disorders Hypothyroidism	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Eye disorders Cataract	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Eye disorders Retinal haemorrhage	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Ascites	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Colitis	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Colitis ischaemic	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Diarrhoea	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Duodenitis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Dysphagia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Faecaloma	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Food poisoning	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Gastric ulcer	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Gastrointestinal haemorrhage	9.9% 7/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.7% 4/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.4% 3/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Haemorrhoidal haemorrhage	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Hiatus hernia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders leus	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Intestinal ischaemia	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Intra-abdominal haematoma	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Nausea	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Pancreatic mass	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Pancreatitis	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Rectal haemorrhage	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Umbilical hernia	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Vomiting	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Asthenia	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Chest discomfort	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Chest pain	7.0% 5/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Death	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Device embolisation	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Generalised oedema	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Medical device site thrombosis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Multiple organ dysfunction syndrome	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Non-cardiac chest pain	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Pyrexia	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Systemic inflammatory response syndrome	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Hepatobiliary disorders Bile duct stone	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Hepatobiliary disorders Cholangitis acute	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Hepatobiliary disorders Cholecystitis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Immune system disorders Anaphylactic reaction	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Appendicitis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Arthritis bacterial	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Atypical pneumonia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Bacteraemia	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Bronchitis	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Cellulitis	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.4% 3/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Corona virus infection	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Diverticulitis	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Epididymitis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Escherichia bacteraemia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Gastroenteritis	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Influenza	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Localised infection	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Necrotising fasciitis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Osteomyelitis	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Parainfluenzae virus infection	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Perineal abscess	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Pneumonia	9.9% 7/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	11.5% 6/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	10.7% 6/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Pneumonia bacterial	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Pneumonia influenzal	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Pneumonia viral	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Post procedural infection	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Postoperative wound infection	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Sepsis	7.0% 5/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.4% 3/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Septic shock	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Staphylococcal infection	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Urinary tract infection	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.7% 4/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.4% 3/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Urinary tract infection bacterial	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Concussion	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Contusion	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Epidural haemorrhage	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Face injury	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Fall	5.6% 4/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Femoral neck fracture	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Foreign body	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Fracture	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Fractured sacrum	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Head injury	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Humerus fracture	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Joint dislocation	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Laceration	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Limb injury	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Periprosthetic fracture	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Rib fracture	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Seroma	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Skull fracture	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Skull fractured base	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Spinal fracture	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Subdural haematoma	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Suture related complication	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Wound	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Investigations Ejection fraction abnormal	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Investigations Haemoglobin decreased	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Investigations Paracentesis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Investigations Transaminases increased	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Investigations Troponin increased	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Metabolism and nutrition disorders Dehydration	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.4% 3/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Metabolism and nutrition disorders Diabetic ketoacidosis	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Metabolism and nutrition disorders Fluid overload	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Metabolism and nutrition disorders Hyperkalaemia	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Metabolism and nutrition disorders Hypoglycaemia	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Metabolism and nutrition disorders Metabolic acidosis	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Hip fracture	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Back pain	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Bursitis	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.7% 4/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct adenocarcinoma	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paget's disease of the vulva	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma recurrent	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Autonomic nervous system imbalance	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Carotid artery stenosis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Cerebral arteriosclerosis	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Cerebral haemorrhage	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Cerebrovascular accident	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Dementia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Dementia with Lewy bodies	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Dizziness	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Dysarthria	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Encephalopathy	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Ischaemic stroke	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Lacunar stroke	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Metabolic encephalopathy	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Migraine with aura	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Mixed dementia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Neuralgia	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Seizure	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Status epilepticus	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Subarachnoid haemorrhage	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Syncope	5.6% 4/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.8% 3/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Transient ischaemic attack	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Visual field defect	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Wernicke's encephalopathy	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Product Issues Device defective	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Product Issues Device leakage	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Product Issues Device loosening	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Product Issues Device malfunction	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Psychiatric disorders Agitation	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Psychiatric disorders Delirium	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Psychiatric disorders Major depression	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Psychiatric disorders Mental status changes	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Psychiatric disorders Nightmare	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Renal and urinary disorders Acute kidney injury	12.7% 9/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Renal and urinary disorders Acute prerenal failure	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Renal and urinary disorders Haematuria	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Renal and urinary disorders Nephrolithiasis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Renal and urinary disorders Obstructive uropathy	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Renal and urinary disorders Urinary retention	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.8% 3/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	12.5% 7/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.7% 4/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.6% 4/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.7% 4/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Vascular disorders Aortic aneurysm	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Vascular disorders Aortic stenosis	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Vascular disorders Deep vein thrombosis	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Vascular disorders Haematoma	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Vascular disorders Hypertension	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Vascular disorders Hypertensive emergency	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Vascular disorders Hypotension	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Vascular disorders Orthostatic hypotension	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Vascular disorders Peripheral artery aneurysm	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Vascular disorders Vasculitis	0.00% 0/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.8% 1/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.

Other adverse events

Measure	Group 1 (WaveCrest Roll-In): n=71 participants at risk Roll in participants who were enrolled prior to a site's randomization phase and who had vascular access attempted, underwent Coherex WaveCrest left atrial appendage (LAA) occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a transseptal puncture into the LAA.	Group 2 (WaveCrest Randomized) n=52 participants at risk Randomized participants underwent Coherex WaveCrest LAA occlusion system (WaveCrest device) implant procedure. Coherex Wave Crest LAA occlusion system delivery sheath was used to deliver the implant percutaneously via the femoral vein through a trans septal puncture into the LAA.	Group 3 (Watchman Randomized) n=56 participants at risk Randomized participants underwent Watchman left atrial appendage closure (LAAC) System (Watchman Device) implant procedure. Watchman device was intended for percutaneous, transcatheter closure of the left atrial appendage and consisted of the watchman access system (access sheath and dilator) and watchman delivery system (delivery catheter and watchman device). The access sheath and delivery catheter permitted device placement in the LAA via femoral venous access and inter-atrial septum crossing into the left atrium.
Blood and lymphatic system disorders Anaemia	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	0.00% 0/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	10.7% 6/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Atrial fibrillation	18.3% 13/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	15.4% 8/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.1% 4/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Cardiac disorders Pericardial effusion	15.5% 11/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	23.1% 12/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	21.4% 12/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Eye disorders Eye disorders	11.3% 8/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	8.9% 5/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Gastrointestinal disorders Gastrointestinal disorders	21.1% 15/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	19.2% 10/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	23.2% 13/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Chest pain	11.3% 8/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	9.6% 5/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	12.5% 7/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Fatigue	2.8% 2/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.8% 3/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.1% 4/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
General disorders Oedema peripheral	8.5% 6/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.8% 3/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	10.7% 6/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Cellulitis	5.6% 4/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.7% 4/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.4% 3/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Corona virus infection	12.7% 9/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	17.3% 9/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	8.9% 5/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Infections and infestations Urinary tract infection	14.1% 10/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	9.6% 5/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	16.1% 9/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Contusion	9.9% 7/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.1% 4/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Fall	8.5% 6/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.1% 4/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Injury, poisoning and procedural complications Laceration	11.3% 8/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	9.6% 5/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	8.9% 5/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Investigations Investigations	11.3% 8/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.7% 4/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	10.7% 6/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Metabolism and nutrition disorders Metabolism and nutrition disorders	19.7% 14/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	25.0% 13/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	17.9% 10/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Musculoskeletal and connective tissue disorders Back pain	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.1% 4/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	10.7% 6/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Dizziness	5.6% 4/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.7% 4/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.1% 4/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Syncope	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.8% 3/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.4% 3/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Nervous system disorders Psychiatric disorders	7.0% 5/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	1.9% 1/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.1% 4/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Renal and urinary disorders Acute kidney injury	12.7% 9/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	10.7% 6/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Renal and urinary disorders Haematuria	4.2% 3/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.7% 4/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	12.5% 7/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Reproductive system and breast disorders Reproductive system and breast disorders	5.6% 4/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.8% 3/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.5% 11/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	11.5% 6/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	14.3% 8/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.6% 4/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.8% 2/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.4% 3/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	15.5% 11/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.7% 4/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	8.9% 5/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Vascular disorders Hypertension	1.4% 1/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	11.5% 6/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	5.4% 3/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.
Vascular disorders Hypotension	9.9% 7/71 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	7.7% 4/52 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.	3.6% 2/56 • Baseline up to 5 years 11 months ITT analysis set consisted of all randomized participants regardless of treatment received.

Additional Information

Senior Director Clinical Research

Coherex Medical, Inc.

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee Results of this clinical study may be submitted for publication without regard for whether the trial results are positive or negative. Sponsor will be responsible for oversight of the publication process and will have oversight of publications of results of the trial, the Physician Advisory Committee may advise.
• Publication restrictions are in place

Restriction type: OTHER