Trial Outcomes & Findings for International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device (NCT NCT02656329)

NCT ID: NCT02656329

Last Updated: 2019-05-22

Results Overview

All-cause mortality included all reported deaths of participants during the study due to any cause. Percentage of participants who died due to any cause were reported.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 395 participants
• Primary outcome timeframe: From randomization until the end of the follow-up period (median 304 days)
• Results posted on: 2019-05-22

Participant Flow

The Study was conducted at 70 centers in United States of America, Canada and Europe between 30 December 2015 and 04 May 2018. A total of 395 participants were enrolled in study, of which 52 were screen failures mainly due to exclusion criteria met.

Out of 343 participants, 321 participants with 25% <=left ventricular ejection fraction (LVEF) <=35% were randomized in a 1:1 ratio to the AdreView™ group or Standard of Care (SoC) group stratified by enrolling center via an interactive web response system and 22 participants were not randomized but included in safety analysis set.

Participant milestones

Measure	AdreView™ Participants received 1 intravenous injection of 10 millicurie (mCi) (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ Heart-to-Mediastinal ratio (H/M) \<1.6 underwent Implantable Cardioverter Defibrillator (ICD) device implantation and H/M \>= 1.6 continued to receive Guideline-Directed Optimal Medical Therapy (GDMT) according to clinical standard practice.	Standard of Care Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted Heart Failure (HF) guidelines.
Overall Study STARTED	164	157
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	164	157

Reasons for withdrawal

Measure	AdreView™ Participants received 1 intravenous injection of 10 millicurie (mCi) (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ Heart-to-Mediastinal ratio (H/M) \<1.6 underwent Implantable Cardioverter Defibrillator (ICD) device implantation and H/M \>= 1.6 continued to receive Guideline-Directed Optimal Medical Therapy (GDMT) according to clinical standard practice.	Standard of Care Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted Heart Failure (HF) guidelines.
Overall Study Lost to Follow-up	2	3
Overall Study Withdrawal by Subject	7	6
Overall Study Study termination by Sponsor	150	142
Overall Study Other than specified above	5	6

Baseline Characteristics

International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device

Baseline characteristics by cohort

Measure	AdreView™ n=164 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ Heart-to-Mediastinal ratio (H/M) \<1.6 underwent Implantable Cardioverter Defibrillator (ICD) device implantation and H/M \>= 1.6 continued to receive GDMT according to clinical standard practice.	Standard of Care n=157 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.	Total n=321 Participants Total of all reporting groups
Age, Continuous	64.1 years STANDARD_DEVIATION 9.40 • n=5 Participants	62.1 years STANDARD_DEVIATION 10.05 • n=7 Participants	63.1 years STANDARD_DEVIATION 9.76 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	22 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	129 Participants n=5 Participants	135 Participants n=7 Participants	264 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	9 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	142 Participants n=5 Participants	140 Participants n=7 Participants	282 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	149 Participants n=5 Participants	137 Participants n=7 Participants	286 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization until the end of the follow-up period (median 304 days)

Population: Analysis was performed on full analysis set (FAS) that was defined as participants included in the safety analysis set who were randomised to the AdreView™ group or the SoC group.

All-cause mortality included all reported deaths of participants during the study due to any cause. Percentage of participants who died due to any cause were reported.

Outcome measures

Measure	AdreView™ n=164 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ H/M ratio \<1.6 underwent ICD device implantation and H/M ratio \>= 1.6 continued to receive GDMT according to clinical standard practice.	Standard of Care n=157 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.
All-cause Mortality	3.0 percentage of participants	3.2 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the end of the follow-up period (median 304 days)

Population: Analysis was performed on FAS population. Here, overall number of participants analyzed = participants with H/M \>=1.6.

Composite of the percentage of participants with events of hospitalization or death related to major complications of device implantation (i.e., need for thoracotomy, pericardiocentesis, or vascular surgery), complications of long-term device therapy (i.e., infection not leading to hospitalization, lead and/or generator removal/replacement, inappropriate shocks, explanation), and combined as 'complications of device' for participants with H/M >=1.6. Participants who were alive at time of database lock (DBL) were censored at the last known-alive date.

Outcome measures

Measure	AdreView™ n=26 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ H/M ratio \<1.6 underwent ICD device implantation and H/M ratio \>= 1.6 continued to receive GDMT according to clinical standard practice.	Standard of Care n=20 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.
Percentage of Participants With Events of Complications of Device: H/M >=1.6 in Full Analysis Set Hospitalization/death	3.8 percentage of participants	0 percentage of participants
Percentage of Participants With Events of Complications of Device: H/M >=1.6 in Full Analysis Set Complications of long-term device therapy	3.8 percentage of participants	15.0 percentage of participants
Percentage of Participants With Events of Complications of Device: H/M >=1.6 in Full Analysis Set Complications of device	3.8 percentage of participants	15.0 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the end of the follow-up period (median 304 days)

Population: Analysis was performed on FAS population.

Cardiac death composed of sudden cardiac death, death due to cardiac arrhythmia, death due to heart failure, and death due to other cardiovascular causes.

Outcome measures

Measure	AdreView™ n=164 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ H/M ratio \<1.6 underwent ICD device implantation and H/M ratio \>= 1.6 continued to receive GDMT according to clinical standard practice.	Standard of Care n=157 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.
Percentage of Participants With Cardiac Death	1.2 percentage of participants	0.6 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the end of the follow-up period (median 304 days)

Population: Analysis was performed on FAS population.

Percentage of participants who were hospitalized for cardiovascular cause were reported.

Outcome measures

Measure	AdreView™ n=164 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ H/M ratio \<1.6 underwent ICD device implantation and H/M ratio \>= 1.6 continued to receive GDMT according to clinical standard practice.	Standard of Care n=157 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.
Percentage of Participants With Hospitalization for Cardiovascular Cause	7.3 percentage of participants	7.6 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the end of the follow-up period (median 304 days)

Population: Analysis was performed on FAS population.

Percentage of participants with all-cause hospitalization were reported.

Outcome measures

Measure	AdreView™ n=164 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ H/M ratio \<1.6 underwent ICD device implantation and H/M ratio \>= 1.6 continued to receive GDMT according to clinical standard practice.	Standard of Care n=157 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.
Percentage of Participants With All-Cause Hospitalization	17.1 percentage of participants	22.3 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the end of the follow-up period (median 304 days)

Population: Analysis was performed on FAS population.

Percentage of participants with composite events i.e occurrence of resuscitated life-threatening ventricular tachycardia, unstable ventricular tachy-arrhythmias, SCD and resuscitated cardiac arrest were reported. Participants who were alive at time of database lock (DBL) were censored at the last known-alive date.

Outcome measures

Measure	AdreView™ n=164 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ H/M ratio \<1.6 underwent ICD device implantation and H/M ratio \>= 1.6 continued to receive GDMT according to clinical standard practice.	Standard of Care n=157 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.
Percentage of Participants With Events (Composite of the Occurrence of Resuscitated Life-Threatening Ventricular Tachycardia, Unstable Ventricular Tachyarrhythmias, Sudden Cardiac Death [SCD] and Resuscitated Cardiac Arrest)	1.2 percentage of participants	2.5 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the end of the follow-up period (median 304 days)

Population: Analysis was performed on FAS population.

Percentage of participants with Syncope were reported. Participants who were alive at time of DBL were censored at the last known-alive date by date of DBL.

Outcome measures

Measure	AdreView™ n=164 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ H/M ratio \<1.6 underwent ICD device implantation and H/M ratio \>= 1.6 continued to receive GDMT according to clinical standard practice.	Standard of Care n=157 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.
Percentage of Participants With Syncope	2.4 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the end of the follow-up period (median 304 days)

Population: Analysis was performed on FAS population.

Percentage of participants with ICD implantation were reported.

Outcome measures

Measure	AdreView™ n=164 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ H/M ratio \<1.6 underwent ICD device implantation and H/M ratio \>= 1.6 continued to receive GDMT according to clinical standard practice.	Standard of Care n=157 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.
Percentage of Participants With Implantable Cardioverter Defibrillator (ICD) Implantation	73.2 percentage of participants	81.5 percentage of participants

SECONDARY outcome

Timeframe: From randomization until the end of the follow-up period (median 304 days)

Population: Analysis was performed on FAS population.

Composite of the percentage of participants with events of hospitalization or death related to major complications of device implantation (i.e., need for thoracotomy, pericardiocentesis, or vascular surgery), complications of long-term device therapy (i.e., infection not leading to hospitalization, lead and/or generator removal/replacement, inappropriate shocks, explanation), and combined as 'complications of device'.

Outcome measures

Measure	AdreView™ n=164 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ H/M ratio \<1.6 underwent ICD device implantation and H/M ratio \>= 1.6 continued to receive GDMT according to clinical standard practice.	Standard of Care n=157 Participants Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.
Percentage of Participants With Events of Complications of Device Hospitalization/death	4.9 percentage of participants	3.8 percentage of participants
Percentage of Participants With Events of Complications of Device Complications of device	5.5 percentage of participants	6.4 percentage of participants
Percentage of Participants With Events of Complications of Device Complications of long-term device therapy	4.3 percentage of participants	6.4 percentage of participants

Adverse Events

AdreView™

Serious events: 65 serious events

Other events: 0 other events

Deaths: 6 deaths

Standard of Care

Serious events: 62 serious events

Other events: 0 other events

Deaths: 5 deaths

Total Participants

Serious events: 127 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Measure	AdreView™ n=164 participants at risk Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ H/M ratio \<1.6 underwent ICD device implantation and H/M ratio \>= 1.6 continued to receive GDMT according to clinical standard practice.	Standard of Care n=157 participants at risk Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted HF guidelines.	Total Participants n=343 participants at risk All participants who were randomized in AdreView™ and Standard of Care group in addition with non-randomized participants who signed informed consent form.
Blood and lymphatic system disorders Iron deficiency anaemia	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Blood and lymphatic system disorders Leukocytosis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Acute myocardial infarction	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Angina pectoris	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.3% 2/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.87% 3/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Angina unstable	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Arrhythmia	3.0% 5/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.3% 2/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	2.0% 7/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Atrial fibrillation	1.8% 3/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.9% 3/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.7% 6/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Cardiac arrest	1.8% 3/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.2% 4/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Cardiac disorder	15.9% 26/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	14.0% 22/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	14.0% 48/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Cardiac failure	4.9% 8/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	3.2% 5/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	3.8% 13/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Cardiac failure congestive	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.3% 2/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.87% 3/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Cardiac perforation	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Cardiac ventricular thrombosis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Cardio-respiratory arrest	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Supraventricular tachycardia	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.3% 2/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Tachycardia	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.3% 2/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Ventricular arrhythmia	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Ventricular extrasystoles	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Cardiac disorders Ventricular tachycardia	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	2.5% 4/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.5% 5/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Ear and labyrinth disorders Vertigo	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Endocrine disorders Hyperthyroidism	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Endocrine disorders Hypothyroidism	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Abdominal pain	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.3% 2/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Abdominal pain upper	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Chronic gastritis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Constipation	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Dental caries	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Diarrhoea	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Diverticulum	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Dyspepsia	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Dysphagia	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Enteritis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Gastroduodenal ulcer	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Haemorrhoids	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Nausea	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Pancreatitis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Rectal haemorrhage	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Gastrointestinal disorders Vomiting	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.3% 2/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
General disorders Chest discomfort	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
General disorders Chest pain	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
General disorders Complication associated with device	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
General disorders Malaise	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
General disorders Medical device site irritation	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
General disorders Non-cardiac chest pain	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
General disorders Oedema peripheral	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
General disorders Pain	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
General disorders Polyp	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Hepatobiliary disorders Cholecystitis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Bronchitis	1.8% 3/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.87% 3/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Cellulitis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Device related infection	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Endocarditis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Gangrene	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Helicobacter infection	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Implant site infection	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Incision site infection	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Infection	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Influenza	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.9% 3/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.5% 5/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Nasopharyngitis	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.3% 2/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Otitis media	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Pneumonia	2.4% 4/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.5% 5/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Post procedural cellulitis	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Respiratory tract infection	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.3% 2/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Sepsis	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Septic shock	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Streptococcal bacteraemia	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Subcutaneous abscess	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Upper respiratory tract infection	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Urinary tract infection	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Viral infection	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Infections and infestations Viral upper respiratory tract infection	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Injury, poisoning and procedural complications Injury	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Injury, poisoning and procedural complications Lower limb fracture	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Injury, poisoning and procedural complications Overdose	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Injury, poisoning and procedural complications Sternal fracture	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Investigations Blood cholesterol increased	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Investigations Blood creatinine increased	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Investigations Blood uric acid increased	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Investigations C-reactive protein increased	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Investigations Weight decreased	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Metabolism and nutrition disorders Cachexia	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Metabolism and nutrition disorders Decreased appetite	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Metabolism and nutrition disorders Diabetes mellitus	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Metabolism and nutrition disorders Dyslipidaemia	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Metabolism and nutrition disorders Gout	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Metabolism and nutrition disorders Hyperglycaemia	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Metabolism and nutrition disorders Hyperkalaemia	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Metabolism and nutrition disorders Hyperuricaemia	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Metabolism and nutrition disorders Hyponatraemia	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Metabolism and nutrition disorders Lactic acidosis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Musculoskeletal and connective tissue disorders Back pain	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.3% 2/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Musculoskeletal and connective tissue disorders Pain in extremity	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stro	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Nervous system disorders Cerebrovascular accident	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Nervous system disorders Dementia Alzheimer's type	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Nervous system disorders Dizziness	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Nervous system disorders Epilepsy	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Nervous system disorders Hemiplegia	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Nervous system disorders Presyncope	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Nervous system disorders Seizure	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Nervous system disorders Syncope	2.4% 4/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.5% 5/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Nervous system disorders Transient ischaemic attack	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Product Issues Device inappropriate shock delivery	1.8% 3/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.3% 2/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.5% 5/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Product Issues Device use issue	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Product Issues Lead dislodgement	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.3% 2/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	1.2% 4/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Psychiatric disorders Anxiety	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Psychiatric disorders Confusional state	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Psychiatric disorders Depression	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Renal and urinary disorders Acute kidney injury	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.87% 3/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Renal and urinary disorders Renal impairment	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Reproductive system and breast disorders Prostatitis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Asthma	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Cough	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Dyspnoea paroxysmal nocturnal	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.58% 2/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.87% 3/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Skin and subcutaneous tissue disorders Rash	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Surgical and medical procedures Implantable defibrillator insertion	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.87% 3/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Vascular disorders Aortic aneurysm	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Vascular disorders Aortic dissection	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Vascular disorders Circulatory collapse	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Vascular disorders Deep vein thrombosis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Vascular disorders Hypertension	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Vascular disorders Hypotension	1.2% 2/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.87% 3/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Vascular disorders Intermittent claudication	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Vascular disorders Lymphoedema	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Vascular disorders Orthostatic hypotension	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Vascular disorders Peripheral artery stenosis	0.00% 0/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.64% 1/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Vascular disorders Peripheral ischaemia	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.
Vascular disorders Phlebitis	0.61% 1/164 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.00% 0/157 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.	0.29% 1/343 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (median 304 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are study-emergent AEs that is AEs and deaths that developed/worsened during any time after randomization until end of the follow-up period (median 304 days). Analysis was performed on safety population which included all participants who signed the informed consent form and met all the inclusion criteria and none of the exclusion criteria.

Other adverse events

Adverse event data not reported

Additional Information

Francois Tranquart, M.D., Ph.D.

GE Healthcare

Phone: 0-44-1494-543037

Email: francois.tranquart@ge.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI and/or institution is that the Sponsor can review results communications prior to public release and can restrict communications regarding trial results for a period that is more than 30 days (publications/abstracts) but not to exceed 90 days (patent related issues) from the time submitted to the Sponsor to review. The PI may be asked to remove any Sponsor confidential information and/or delay publication to protect any proprietary information.
• Publication restrictions are in place

Restriction type: OTHER