Trial Outcomes & Findings for Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure (NCT NCT02501811)

NCT ID: NCT02501811

Last Updated: 2021-04-26

Results Overview

Change in left ventricular ejection fraction as assessed via cardiac MRI

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 125 participants
• Primary outcome timeframe: Baseline to 6 months
• Results posted on: 2021-04-26

Participant Flow

Enrollment took place at seven CCTRN centers between November 2016 and November 2018. The main centers are located in Texas, Florida (2 locations), Minnesota, Kentucky, Indiana, and California. Recruitment methods included www.clinicaltrials.gov, local heart failure clinics, and outreach to physician cardiologists. Original sample size of 144 was capped at 125 by NHLBI following review by DSMB of cell production, interim analysis, and power calculations. Power deemed adequate at 125 subjects.

125 individuals consented, completed baseline testing, met eligibility criteria, and were randomized to study group. Reasons for failed eligibility (n=68) included investigator discretion, elevated LVEF, MRI contraindications, LV thrombus requiring anticoagulation therapy, elevated peak VO2, and other.

Participant milestones

Measure	MSCs + CPCs Target dose of 150 million MSCs and 5 million CPCs	MSCs Target dose of 150 million MSCs	CPCs Target dose of 5 million CPCs	Placebo Plasmalyte A
Overall Study STARTED	33	29	31	32
Overall Study COMPLETED	29	23	25	25
Overall Study NOT COMPLETED	4	6	6	7

Reasons for withdrawal

Measure	MSCs + CPCs Target dose of 150 million MSCs and 5 million CPCs	MSCs Target dose of 150 million MSCs	CPCs Target dose of 5 million CPCs	Placebo Plasmalyte A
Overall Study Death	1	3	2	3
Overall Study Withdrawal by Subject	3	3	2	3
Overall Study Lost to Follow-up	0	0	2	1

Baseline Characteristics

One participant missing data

Baseline characteristics by cohort

Measure	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs	Placebo n=32 Participants Plasmalyte A	Total n=125 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 11.1 • n=33 Participants	61.7 years STANDARD_DEVIATION 6.7 • n=29 Participants	64.2 years STANDARD_DEVIATION 8.1 • n=31 Participants	63.1 years STANDARD_DEVIATION 8.0 • n=32 Participants	62.5 years STANDARD_DEVIATION 8.9 • n=125 Participants
Sex: Female, Male Female	2 Participants n=33 Participants	2 Participants n=29 Participants	4 Participants n=31 Participants	1 Participants n=32 Participants	9 Participants n=125 Participants
Sex: Female, Male Male	31 Participants n=33 Participants	27 Participants n=29 Participants	27 Participants n=31 Participants	31 Participants n=32 Participants	116 Participants n=125 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=33 Participants	5 Participants n=29 Participants	6 Participants n=31 Participants	4 Participants n=32 Participants	20 Participants n=125 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=33 Participants	22 Participants n=29 Participants	25 Participants n=31 Participants	28 Participants n=32 Participants	103 Participants n=125 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=33 Participants	2 Participants n=29 Participants	0 Participants n=31 Participants	0 Participants n=32 Participants	2 Participants n=125 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=33 Participants	0 Participants n=29 Participants	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=125 Participants
Race (NIH/OMB) Asian	0 Participants n=33 Participants	1 Participants n=29 Participants	1 Participants n=31 Participants	1 Participants n=32 Participants	3 Participants n=125 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=33 Participants	0 Participants n=29 Participants	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=125 Participants
Race (NIH/OMB) Black or African American	3 Participants n=33 Participants	0 Participants n=29 Participants	0 Participants n=31 Participants	2 Participants n=32 Participants	5 Participants n=125 Participants
Race (NIH/OMB) White	30 Participants n=33 Participants	27 Participants n=29 Participants	28 Participants n=31 Participants	28 Participants n=32 Participants	113 Participants n=125 Participants
Race (NIH/OMB) More than one race	0 Participants n=33 Participants	0 Participants n=29 Participants	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=125 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=33 Participants	1 Participants n=29 Participants	2 Participants n=31 Participants	1 Participants n=32 Participants	4 Participants n=125 Participants
Region of Enrollment United States	33 participants n=33 Participants	29 participants n=29 Participants	31 participants n=31 Participants	32 participants n=32 Participants	125 participants n=125 Participants
Body Mass Index	31.2 kg/m^2 STANDARD_DEVIATION 3.5 • n=33 Participants	30.4 kg/m^2 STANDARD_DEVIATION 5.4 • n=29 Participants	29.4 kg/m^2 STANDARD_DEVIATION 5.0 • n=31 Participants	30.0 kg/m^2 STANDARD_DEVIATION 4.4 • n=32 Participants	30.3 kg/m^2 STANDARD_DEVIATION 4.6 • n=125 Participants
Systolic Blood Pressure	118.4 mmHg STANDARD_DEVIATION 18.2 • n=33 Participants	114.0 mmHg STANDARD_DEVIATION 11.3 • n=29 Participants	117.3 mmHg STANDARD_DEVIATION 17.9 • n=31 Participants	117.2 mmHg STANDARD_DEVIATION 17.6 • n=32 Participants	116.8 mmHg STANDARD_DEVIATION 16.5 • n=125 Participants
Diastolic Blood Pressure	70.2 mmHg STANDARD_DEVIATION 9.3 • n=33 Participants	70.1 mmHg STANDARD_DEVIATION 9.0 • n=29 Participants	68.3 mmHg STANDARD_DEVIATION 10.8 • n=31 Participants	67.7 mmHg STANDARD_DEVIATION 11.2 • n=32 Participants	69.0 mmHg STANDARD_DEVIATION 10.1 • n=125 Participants
Diabetes	7 Participants n=33 Participants • One participant missing data	10 Participants n=28 Participants • One participant missing data	10 Participants n=31 Participants • One participant missing data	12 Participants n=32 Participants • One participant missing data	39 Participants n=124 Participants • One participant missing data
Hypertension	29 Participants n=33 Participants • One participant missing data	23 Participants n=28 Participants • One participant missing data	26 Participants n=31 Participants • One participant missing data	27 Participants n=32 Participants • One participant missing data	105 Participants n=124 Participants • One participant missing data
Smoking (Lifetime)	19 Participants n=33 Participants	18 Participants n=29 Participants	24 Participants n=31 Participants	22 Participants n=32 Participants	83 Participants n=125 Participants
Previous Hospitalization for Heart Failure	11 Participants n=33 Participants	8 Participants n=29 Participants	9 Participants n=31 Participants	13 Participants n=32 Participants	41 Participants n=125 Participants
Previous Emergency Department Visit for Heart Failure	6 Participants n=33 Participants	4 Participants n=29 Participants	8 Participants n=31 Participants	9 Participants n=32 Participants	27 Participants n=125 Participants
Ongoing Ischemia	9 Participants n=33 Participants	5 Participants n=29 Participants	4 Participants n=31 Participants	7 Participants n=32 Participants	25 Participants n=125 Participants
New York Heart Association Class 1	1 Participants n=33 Participants	1 Participants n=29 Participants	3 Participants n=31 Participants	1 Participants n=32 Participants	6 Participants n=125 Participants
New York Heart Association Class 2	24 Participants n=33 Participants	22 Participants n=29 Participants	26 Participants n=31 Participants	28 Participants n=32 Participants	100 Participants n=125 Participants
New York Heart Association Class 3	8 Participants n=33 Participants	6 Participants n=29 Participants	2 Participants n=31 Participants	3 Participants n=32 Participants	19 Participants n=125 Participants
Presence of a Cardiac Device	28 Participants n=33 Participants	24 Participants n=29 Participants	28 Participants n=31 Participants	21 Participants n=32 Participants	101 Participants n=125 Participants
Number of Myocardial Infarctions	1.6 events STANDARD_DEVIATION 1.0 • n=33 Participants	1.9 events STANDARD_DEVIATION 1.7 • n=29 Participants	1.9 events STANDARD_DEVIATION 1.2 • n=31 Participants	1.7 events STANDARD_DEVIATION 1.0 • n=32 Participants	1.8 events STANDARD_DEVIATION 1.3 • n=125 Participants
Percutaneous Coronary Intervention (PCI)	27 Participants n=33 Participants	24 Participants n=29 Participants	27 Participants n=31 Participants	28 Participants n=32 Participants	106 Participants n=125 Participants
Coronary Artery Bypass Grafting (CABG)	17 Participants n=33 Participants	14 Participants n=29 Participants	16 Participants n=31 Participants	15 Participants n=32 Participants	62 Participants n=125 Participants
Multi-Vessel Disease	25 Participants n=33 Participants	22 Participants n=29 Participants	28 Participants n=31 Participants	30 Participants n=32 Participants	105 Participants n=125 Participants
Atrial Fibrillation	11 Participants n=33 Participants	8 Participants n=29 Participants	11 Participants n=31 Participants	10 Participants n=32 Participants	40 Participants n=125 Participants
Sustained Ventricular Arrhythmia	12 Participants n=32 Participants • One participant missing data	5 Participants n=29 Participants • One participant missing data	4 Participants n=31 Participants • One participant missing data	7 Participants n=32 Participants • One participant missing data	28 Participants n=124 Participants • One participant missing data
Valvular Heart Disease	22 Participants n=33 Participants	17 Participants n=29 Participants	26 Participants n=31 Participants	24 Participants n=32 Participants	89 Participants n=125 Participants
Beta Blockers	32 Participants n=33 Participants	26 Participants n=29 Participants	29 Participants n=31 Participants	31 Participants n=32 Participants	118 Participants n=125 Participants
ACE Inhibitors	16 Participants n=33 Participants	10 Participants n=29 Participants	18 Participants n=31 Participants	8 Participants n=32 Participants	52 Participants n=125 Participants
Angiotensin II Blockers	8 Participants n=33 Participants	5 Participants n=29 Participants	6 Participants n=31 Participants	9 Participants n=32 Participants	28 Participants n=125 Participants
Entresto	8 Participants n=33 Participants	11 Participants n=29 Participants	7 Participants n=31 Participants	13 Participants n=32 Participants	39 Participants n=125 Participants
Aldosterone Antagonists	18 Participants n=33 Participants	20 Participants n=29 Participants	20 Participants n=31 Participants	22 Participants n=32 Participants	80 Participants n=125 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Participants with available analyzable LVEF at baseline and 6 months

Change in left ventricular ejection fraction as assessed via cardiac MRI

Outcome measures

Measure	Placebo n=25 Participants Plasmalyte A	MSCs + CPCs n=28 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=24 Participants Target dose of 150 million MSCs	CPCs n=25 Participants Target dose of 5 million CPCs
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)	-0.33 percentage of end diastolic volume Standard Deviation 3.73	-0.42 percentage of end diastolic volume Standard Deviation 3.90	0.37 percentage of end diastolic volume Standard Deviation 2.95	1.05 percentage of end diastolic volume Standard Deviation 3.68

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Participants with available analyzable global circumferential strain at baseline and 6 months.

Change in global circumferential strain as assessed via cardiac MRI

Outcome measures

Measure	Placebo n=16 Participants Plasmalyte A	MSCs + CPCs n=26 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=17 Participants Target dose of 150 million MSCs	CPCs n=22 Participants Target dose of 5 million CPCs
Change From Baseline in Global Strain (HARP MRI)	-0.10 percent Standard Deviation 3.38	-0.36 percent Standard Deviation 3.20	0.48 percent Standard Deviation 3.36	0.56 percent Standard Deviation 2.08

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Participants with available analyzable regional longitudinal strain at baseline and 6 months

Change in regional longitudinal strain as assessed via cardiac MRI

Outcome measures

Measure	Placebo n=17 Participants Plasmalyte A	MSCs + CPCs n=26 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=18 Participants Target dose of 150 million MSCs	CPCs n=22 Participants Target dose of 5 million CPCs
Change From Baseline in Regional Strain (HARP MRI)	-0.91 percent Standard Deviation 2.44	-0.50 percent Standard Deviation 2.33	-0.51 percent Standard Deviation 2.33	-0.76 percent Standard Deviation 2.49

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Participants with available analyzable LVEDVI at baseline and six months

Change in left ventricular end diastolic volume index as measured via cardiac MRI

Outcome measures

Measure	Placebo n=25 Participants Plasmalyte A	MSCs + CPCs n=28 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=24 Participants Target dose of 150 million MSCs	CPCs n=25 Participants Target dose of 5 million CPCs
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)	2.99 mL/m^2 Standard Deviation 11.84	0.97 mL/m^2 Standard Deviation 16.06	0.21 mL/m^2 Standard Deviation 11.91	-1.13 mL/m^2 Standard Deviation 12.37

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Participants with available analyzable LVESVI at baseline and 6 months

Change in left ventricular end systolic volume index as assessed via cardiac MRI

Outcome measures

Measure	Placebo n=25 Participants Plasmalyte A	MSCs + CPCs n=28 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=24 Participants Target dose of 150 million MSCs	CPCs n=25 Participants Target dose of 5 million CPCs
Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI)	2.23 mL/m^2 Standard Deviation 10.69	0.98 mL/m^2 Standard Deviation 11.17	-0.22 mL/m^2 Standard Deviation 10.75	-2.37 mL/m^2 Standard Deviation 11.09

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Participants with available analyzable LV sphericity index at baseline and 6 months

Change in left ventricular sphericity as assessed via cardiac MRI. Sphericity index is the ratio of the long and short axis measurements of the left ventricle.

Outcome measures

Measure	Placebo n=25 Participants Plasmalyte A	MSCs + CPCs n=26 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=24 Participants Target dose of 150 million MSCs	CPCs n=25 Participants Target dose of 5 million CPCs
Change From Baseline in Left Ventricular Sphericity Index	0.01 ratio-unitless Standard Deviation 0.08	0.00 ratio-unitless Standard Deviation 0.07	-0.00 ratio-unitless Standard Deviation 0.07	0.00 ratio-unitless Standard Deviation 0.08

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Participants with available and analyzable scar size data at baseline and 6 months

Change in scar size percent as assessed via cardiac MRI

Outcome measures

Measure	Placebo n=21 Participants Plasmalyte A	MSCs + CPCs n=22 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=20 Participants Target dose of 150 million MSCs	CPCs n=22 Participants Target dose of 5 million CPCs
Change From Baseline in Scar Size Percent (DEMRI)	-0.53 percentage of mass Standard Deviation 2.29	-0.57 percentage of mass Standard Deviation 3.25	-0.70 percentage of mass Standard Deviation 2.80	-1.06 percentage of mass Standard Deviation 2.40

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Participants with available and analyzable scar size data at baseline and 6 months

Change in scar tissue mass as assessed via cardiac MRI

Outcome measures

Measure	Placebo n=21 Participants Plasmalyte A	MSCs + CPCs n=22 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=20 Participants Target dose of 150 million MSCs	CPCs n=22 Participants Target dose of 5 million CPCs
Change From Baseline in Scar Tissue Mass (DEMRI)	-1.31 grams Standard Deviation 4.07	-0.87 grams Standard Deviation 5.21	-1.13 grams Standard Deviation 3.71	-2.51 grams Standard Deviation 4.51

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Participants with available analyzable peak VO2 data from baseline and 6 months

Change in maximal oxygen consumption (peak V02) as assessed via treadmill

Outcome measures

Measure	Placebo n=26 Participants Plasmalyte A	MSCs + CPCs n=28 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=23 Participants Target dose of 150 million MSCs	CPCs n=25 Participants Target dose of 5 million CPCs
Change From Baseline in Maximal Oxygen Consumption (Peak VO2)	0.13 ml/kg/min Standard Deviation 2.28	-0.89 ml/kg/min Standard Deviation 2.94	-0.83 ml/kg/min Standard Deviation 3.75	0.77 ml/kg/min Standard Deviation 2.86

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Participants with available analyzable exercise tolerance data at baseline and 6 months

Change in distance walked (in meters) as measured by the 6 minute walk test. Two walk tests were completed at each endpoint visit (separated by 30 minutes). The average distance of the two walk tests was used for analysis.

Outcome measures

Measure	Placebo n=27 Participants Plasmalyte A	MSCs + CPCs n=29 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=24 Participants Target dose of 150 million MSCs	CPCs n=25 Participants Target dose of 5 million CPCs
Change From Baseline in Exercise Tolerance (Six Minute Walk Test)	0.67 meters Standard Deviation 70.54	19.24 meters Standard Deviation 71.65	23.85 meters Standard Deviation 57.03	2.36 meters Standard Deviation 44.30

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Participants with available analyzable MLHFQ summary score at baseline and 6 months

Change in the quality of life summary score as measured by the Minnesota Living with Heart Failure Questionnaire. Minimum and maximum scores for the scale are 0 and 105 respectively. Lower scores indicative of better outcomes.

Outcome measures

Measure	Placebo n=28 Participants Plasmalyte A	MSCs + CPCs n=30 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=24 Participants Target dose of 150 million MSCs	CPCs n=25 Participants Target dose of 5 million CPCs
Change From Baseline in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score	-5.68 score on a scale Standard Deviation 18.23	-15.32 score on a scale Standard Deviation 16.94	-20.78 score on a scale Standard Deviation 23.11	-8.65 score on a scale Standard Deviation 23.72

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Participants with available analyzable NT-proBNP values at baseline and 6 months. Log transformation used. P-values obtained from transformed data.

Change in N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) as measured via laboratory blood draw

Outcome measures

Measure	Placebo n=27 Participants Plasmalyte A	MSCs + CPCs n=29 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=23 Participants Target dose of 150 million MSCs	CPCs n=25 Participants Target dose of 5 million CPCs
Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)	687.25 pg/ml Standard Deviation 2006.72	-724.46 pg/ml Standard Deviation 4020.53	52.6 pg/ml Standard Deviation 586.16	204.09 pg/ml Standard Deviation 533.51

PRIMARY outcome

Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)

Population: Participants who had analyzable LVEF at baseline, 6 months, and 12 months.

The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm.

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)-Trajectory	-0.175 percentage of end diastolic volume Standard Error 0.332	0.167 percentage of end diastolic volume Standard Error 0.551	0.422 percentage of end diastolic volume Standard Error 0.480	0.633 percentage of end diastolic volume Standard Error 0.411

PRIMARY outcome

Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)

Population: Participants who had available analyzable global circumferential strain at baseline, 6 month, and 12 month.

The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm.

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Change From Baseline in Global Strain (HARP MRI)-Trajectory	0.576 percent Standard Error 0.417	0.126 percent Standard Error 0.239	-0.324 percent Standard Error 0.283	0.276 percent Standard Error 0.300

PRIMARY outcome

Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)

Population: Participants who had analyzable regional strain at baseline, 6 months, and 12 months

The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm.

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Change From Baseline in Regional Strain (HARP MRI)-Trajectory	-0.288 percent Standard Error 0.360	-0.084 percent Standard Error 0.287	-0.385 percent Standard Error 0.350	-0.325 percent Standard Error 0.323

PRIMARY outcome

Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)

Population: Participants who had analyzable LVEDVI at baseline, 6 months, and 12 months

The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm.

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)-Trajectory	1.862 mL/m^2 Standard Error 1.980	1.538 mL/m^2 Standard Error 1.585	0.320 mL/m^2 Standard Error 1.303	1.796 mL/m^2 Standard Error 1.393

PRIMARY outcome

Timeframe: Assessed as a trajectory (baseline, 6 months, 12 months)

Population: Participants who had analyzable LVESVI at baseline, 6 months, and 12 months

The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm.

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI)-Trajectory	1.077 mL/m^2 Standard Error 1.709	0.826 mL/m^2 Standard Error 1.158	-0.394 mL/m^2 Standard Error 1.117	0.626 mL/m^2 Standard Error 1.288

PRIMARY outcome

Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)

Population: Participants who had analyzable LV Sphericity Index at baseline, 6 months, and 12 months

Sphericity index is the ratio of the long and short axis measurements of the left ventricle. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm.

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Change From Baseline in Left Ventricular Sphericity Index-Trajectory	0.002 ratio-unitless Standard Error 0.012	0.004 ratio-unitless Standard Error 0.007	-0.004 ratio-unitless Standard Error 0.008	0.008 ratio-unitless Standard Error 0.007

PRIMARY outcome

Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)

Population: Participants who had analyzable scar size percent at baseline, 6 months, and 12 months

The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm.

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Change From Baseline in Scar Size Percent (DEMRI)-Trajectory	-0.013 percentage of mass Standard Error 0.340	-0.341 percentage of mass Standard Error 0.314	-0.290 percentage of mass Standard Error 0.231	-0.427 percentage of mass Standard Error 0.306

PRIMARY outcome

Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)

Population: Participants who had analyzable scar size data at baseline, 6 months, and 12 months

The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm.

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Change From Baseline in Scar Tissue Mass (DEMRI)-Trajectory	-0.390 grams Standard Error 0.549	-0.309 grams Standard Error 0.539	-0.266 grams Standard Error 0.367	-0.958 grams Standard Error 0.615

PRIMARY outcome

Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)

Population: Participants who had analyzable peak VO2 at baseline, 6 months, and 12 months

The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm.

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Change From Baseline in Maximal Oxygen Consumption (Peak VO2)-Trajectory	-0.093 ml/kg/min Standard Error 0.369	-0.711 ml/kg/min Standard Error 0.352	0.632 ml/kg/min Standard Error 0.275	-0.165 ml/kg/min Standard Error 0.325

PRIMARY outcome

Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)

Population: Participants who had analyzable six minute walk tests at baseline, 6 months, and 12 months

Two walk tests were completed at each endpoint visit (separated by 30 minutes). The average distance of the two walk tests was used for analysis. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm.

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Change From Baseline in Exercise Tolerance (Six Minute Walk Test)-Trajectory	-4.248 meters Standard Error 5.215	9.996 meters Standard Error 5.558	11.434 meters Standard Error 5.531	6.776 meters Standard Error 6.192

PRIMARY outcome

Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)

Population: Participants who had analyzable MLHFQ scores at baseline, 6 months, and 12 months

Minimum and maximum scores for the scale are 0 and 105 respectively. Lower scores indicative of better outcomes. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The 2nd and 3rd set of results represent differences for varying slopes from the interaction model.

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Change From Baseline in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score-Trajectory	-2.378 score on a scale Standard Error 2.357	-9.258 score on a scale Standard Error 2.079	-7.295 score on a scale Standard Error 2.746	0.776 score on a scale Standard Error 1.731

PRIMARY outcome

Timeframe: Assessed as a trajectory (baseline, 6 months, and 12 months)

Population: Participants who had analyzable NT-proBNP values at baseline, 6 months, and 12 months

Log transformation used. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm.

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)-Trajectory	185.210 pg/ml Standard Error 99.190	74.650 pg/ml Standard Error 72.303	102.250 pg/ml Standard Error 46.194	61.680 pg/ml Standard Error 57.365

PRIMARY outcome

Timeframe: Baseline to End of 12 Month Visit Window, an average of 395 days following study product injection

Population: Population includes all randomized participants

Number of participants with adjudicated events including death, hospitalization for worsening heart failure, and/or other exacerbation of heart failure (non-hospitalization).

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Participants With Major Adverse Cardiac Events (MACE)	9 Participants	3 Participants	7 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline to End of 12 Month Visit Window, an average of 395 days following study product injection

Population: Population includes all randomized participants

Number of participants experiencing other significant adjudicated clinical events including: non-fatal stroke, non-fatal MI, coronary artery revascularization, ventricular tachycardia/fibrillation, and pericardial tamponade

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Participants Experiencing Other Significant Clinical Events	7 Participants	8 Participants	3 Participants	11 Participants

PRIMARY outcome

Timeframe: Baseline to End of 12 Month Visit Window, an average of 395 days following study product injection

Population: Comparison of the 4 treatment groups on days alive and out of the hospital for heart failure during the 12 month study evaluation period; adjusted for time in followup. Analysis includes all randomized participants.

Days alive and out of hospital during the study evaluation period. Subjects were allotted a visit window extending 30 days past their anticipated 12-month visit. Some participants had extended 12-month visit windows due to the COVID-19 pandemic.

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Cumulative Days Alive and Out of Hospital for Heart Failure	427 days Standard Deviation 158	472 days Standard Deviation 121	448 days Standard Deviation 120	438 days Standard Deviation 163

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to SPI, an average of 14 weeks

Population: All randomized participants

Number and percent of subjects with events between randomization and study product injection (SPI) that preclude the subject from receiving product. Reasons include those who did not undergo harvest (n=6; death, subject withdraw, subject changed mind) and those who did not undergo SPI (n=9; death, LVAD placement, episodes of ventricular tachycardia, and cancelled procedures)

Outcome measures

Measure	Placebo n=32 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 Participants Target dose of 150 million MSCs	CPCs n=31 Participants Target dose of 5 million CPCs
Subjects With Events Between Randomization and Study Product Injection (SPI) That Preclude the Receipt of Product	4 Participants	3 Participants	4 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During bone marrow aspiration procedure

Population: Participants who attended their harvest visit

Number and percent of subjects who do not successfully undergo bone marrow aspiration

Outcome measures

Measure	Placebo n=29 Participants Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=27 Participants Target dose of 150 million MSCs	CPCs n=30 Participants Target dose of 5 million CPCs
Subjects Who Have a Failed Bone Marrow Aspiration Procedure	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During endomyocardial biopsy procedure

Population: Participants who attended the harvest visit and were assigned to either MSCs+CPCs or CPCs.

Number and percent of subjects who do not successfully undergo endomyocardial biopsy procedure. Note only participants who were assigned to MSC+CPC or to CPC groups had endomyocardial biopsy procedures attempted.

Outcome measures

Measure	Placebo Plasmalyte A	MSCs + CPCs n=33 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs Target dose of 150 million MSCs	CPCs n=30 Participants Target dose of 5 million CPCs
Subjects Who Have a Failed Endomyocardial Biopsy Procedure	0 Participants	0 Participants	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Harvest to Study Product Injection Procedure

Population: Population includes only those participant products assigned to treatment groups including MSCs.

Number and percent of subjects who have MSC products which failed release criteria

Outcome measures

Measure	Placebo Plasmalyte A	MSCs + CPCs n=30 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=25 Participants Target dose of 150 million MSCs	CPCs Target dose of 5 million CPCs
Subject MSC Products Which Failed Release Criteria	—	8 Participants	6 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Harvest to Study Project Injection procedure

Population: Population includes only those participant products assigned to treatment groups including CPCs.

Number and percent of subjects who have CPC products which failed release criteria

Outcome measures

Measure	Placebo Plasmalyte A	MSCs + CPCs n=30 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs Target dose of 150 million MSCs	CPCs n=27 Participants Target dose of 5 million CPCs
Subject CPC Products Which Failed Release Criteria	—	5 Participants	—	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During SPI procedure

Population: Participants who received study product administration

Number and percent of subjects who received less than 15 injections during SPI

Outcome measures

Measure	Placebo n=28 Participants Plasmalyte A	MSCs + CPCs n=30 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=25 Participants Target dose of 150 million MSCs	CPCs n=27 Participants Target dose of 5 million CPCs
Subjects Who Receive Less Than 15 Injections During SPI	1 Participants	2 Participants	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Population: Participants completing an MRI scan at both baseline and 12 months

Number and percent of subjects who have at least one cardiac MRI endpoint measure that is uninterpretable due to issues related to the device, including, but not limited to, inability to undergo the procedure

Outcome measures

Measure	Placebo n=22 Participants Plasmalyte A	MSCs + CPCs n=29 Participants Target dose of 150 million MSCs and 5 million CPCs	MSCs n=20 Participants Target dose of 150 million MSCs	CPCs n=23 Participants Target dose of 5 million CPCs
Subjects Who Have at Least One Cardiac MRI Endpoint Measure That is Uninterpretable	3 Participants	5 Participants	1 Participants	1 Participants

Adverse Events

MSCs + CPCs

Serious events: 14 serious events

Other events: 10 other events

Deaths: 2 deaths

MSCs

Serious events: 14 serious events

Other events: 6 other events

Deaths: 3 deaths

CPCs

Serious events: 13 serious events

Other events: 14 other events

Deaths: 2 deaths

Placebo

Serious events: 18 serious events

Other events: 15 other events

Deaths: 4 deaths

Serious adverse events

Measure	MSCs + CPCs n=33 participants at risk Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 participants at risk Target dose of 150 million MSCs	CPCs n=31 participants at risk Target dose of 5 million CPCs	Placebo n=32 participants at risk Plasmalyte A
Blood and lymphatic system disorders Anaemia or Iron Deficiency Anaemia	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Blood and lymphatic system disorders Thrombocytopenia	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Acute myocardial infarction	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.5% 2/31 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Angina pectoris or angina unstable	6.1% 2/33 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.2% 2/32 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Atrial fibrillation	6.1% 2/33 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.9% 2/29 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.5% 2/31 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Bundle branch block left	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Cardiac arrest	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Cardiac failure acute	9.1% 3/33 • Number of events 4 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	10.3% 3/29 • Number of events 4 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	31.2% 10/32 • Number of events 20 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Cardiac failure chronic	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Cardiac failure congestive	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Cardiac tamponade	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Cardiogenic shock	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.9% 2/29 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Myocardial infarction	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Myocardial ischaemia	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Pericardial effusion	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Pericardial haemorrhage	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Pulseless electrical activity	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Supraventricular tachycardia	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Ventricular arrhythmia	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Ventricular fibrillation	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Ventricular tachycardia	6.1% 2/33 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.9% 2/29 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	16.1% 5/31 • Number of events 6 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	9.4% 3/32 • Number of events 3 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Gastrointestinal disorders Nausea	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Gastrointestinal disorders Pancreatitis	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
General disorders Sudden cardiac death	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
General disorders Death	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
General disorders Non-cardiac chest pain	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
General disorders Medical device site erosion	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Hepatobiliary disorders Cholelithiasis	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Hepatobiliary disorders Hepatocellular injury	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Bronchitis	6.1% 2/33 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Cellulitis	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Cystitis	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Diverticulitis	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Enterocolitis infectious	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Oesophageal candidiasis	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Osteomyelitis	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Pneumonia	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Septic shock	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Subcutaneous abscess	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Upper respiratory tract infection	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Urinary tract infection	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.2% 2/32 • Number of events 6 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Injury, poisoning and procedural complications Vascular access site pseudoaneurysm	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Injury, poisoning and procedural complications Head injury	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Injury, poisoning and procedural complications Joint dislocation	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Metabolism and nutrition disorders Dehydration	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Nervous system disorders Syncope	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.9% 2/29 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Nervous system disorders Sciatica	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Nervous system disorders Cerebrovascular accident	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Nervous system disorders Cerebellar infarction	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Product Issues Device lead damage	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Product Issues Device inappropriate shock delivery	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Renal and urinary disorders Acute kidney injury	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.5% 2/31 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	9.4% 3/32 • Number of events 4 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Renal and urinary disorders Urinary bladder haemorrhage	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.0% 1/33 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Skin and subcutaneous tissue disorders Hidradenitis	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Skin and subcutaneous tissue disorders Rash	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Surgical and medical procedures Ventricular assist device insertion	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Vascular disorders Hypotension	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.2% 2/32 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Vascular disorders Aortic aneurysm	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Vascular disorders Peripheral artery aneurysm	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Vascular disorders Arteriovenous fistula	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Vascular disorders Hypovolaemic shock	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.

Other adverse events

Measure	MSCs + CPCs n=33 participants at risk Target dose of 150 million MSCs and 5 million CPCs	MSCs n=29 participants at risk Target dose of 150 million MSCs	CPCs n=31 participants at risk Target dose of 5 million CPCs	Placebo n=32 participants at risk Plasmalyte A
Blood and lymphatic system disorders Anaemia	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.9% 2/29 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Angina pectoris or angina unstable	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.5% 2/31 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Atrial fibrillation	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	9.7% 3/31 • Number of events 3 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Cardiac failure	6.1% 2/33 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Cardiac failure acute	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	12.5% 4/32 • Number of events 4 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Cardiac disorders Ventricular tachycardia	15.2% 5/33 • Number of events 6 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	9.7% 3/31 • Number of events 3 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Bronchitis	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.5% 2/31 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.2% 2/32 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Pneumonia	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	9.4% 3/32 • Number of events 3 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Infections and infestations Upper respiratory tract infection	6.1% 2/33 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.2% 2/32 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Metabolism and nutrition disorders Fluid overload	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.5% 2/31 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Metabolism and nutrition disorders Gout	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.2% 2/32 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Metabolism and nutrition disorders Hyperglycaemia	6.1% 2/33 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.5% 2/31 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Nervous system disorders Syncope	3.0% 1/33 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.4% 1/29 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.2% 2/32 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Renal and urinary disorders Acute kidney injury	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.2% 2/32 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Renal and urinary disorders Haematuria	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.5% 2/31 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.1% 1/32 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Renal and urinary disorders Urinary retention	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	9.4% 3/32 • Number of events 3 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.9% 2/29 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/29 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/31 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.2% 2/32 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Surgical and medical procedures Cardiac resynchronisation therapy	0.00% 0/33 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	6.9% 2/29 • Number of events 2 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	3.2% 1/31 • Number of events 1 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.	0.00% 0/32 • Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection). Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.

Additional Information

Shelly Sayre, M.P.H. Project Manager

University of Texas-Houston School of Public Health

Phone: 713-500-9529

Email: Shelly.L.Sayre@uth.tmc.edu

Results disclosure agreements

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