Trial Outcomes & Findings for Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure (NCT NCT00454818)

Last Updated: 2014-08-20

Results Overview

Includes all adverse events that occurred from the time of first infusion of the investigational product or placebo to the 12-month visit. The category of "TEAEs related to the investigational product (IP)" includes TEAEs considered by the investigator to be possibly, probably, or definitely related to the IP.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

51 participants

Primary outcome timeframe

12 months

Results posted on

2014-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	MYDICAR® Very Low Dose Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion. This arm was included only in the Phase I open-label dose-escalation period.	MYDICAR® Low Dose Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion. The placebo arm was included only in the Phase 2 randomized double-blind period.
Phase I: Open-label Dose-escalation STARTED	3	3	3	3	0
Phase I: Open-label Dose-escalation COMPLETED	2	2	2	2	0
Phase I: Open-label Dose-escalation NOT COMPLETED	1	1	1	1	0
Phase 2: Randomized Double-blind STARTED	0	8	8	9	14
Phase 2: Randomized Double-blind COMPLETED	0	6	5	8	10
Phase 2: Randomized Double-blind NOT COMPLETED	0	2	3	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	MYDICAR® Very Low Dose Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion. This arm was included only in the Phase I open-label dose-escalation period.	MYDICAR® Low Dose Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion. The placebo arm was included only in the Phase 2 randomized double-blind period.
Phase I: Open-label Dose-escalation Received heart transplant	1	0	0	0	0
Phase I: Open-label Dose-escalation Death	0	1	0	0	0
Phase I: Open-label Dose-escalation Received left ventricular assist device	0	0	1	1	0
Phase 2: Randomized Double-blind Received milrinone or dobutamine	0	1	0	1	0
Phase 2: Randomized Double-blind Death	0	1	0	0	1
Phase 2: Randomized Double-blind Received a heart transplant	0	0	2	0	1
Phase 2: Randomized Double-blind Received left ventricular assist device	0	0	1	0	2

Baseline Characteristics

Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: MYDICAR® Very Low Dose n=3 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DRP administered by antegrade epicardial coronary artery infusion.	Phase 1: MYDICAR® Low Dose n=3 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	Phase 1: MYDICAR® Mid Dose n=3 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	Phase 1: MYDICAR® High Dose n=3 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Phase 2: MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	Phase 2: MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	Phase 2: MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Phase 2: Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	Total n=51 Participants Total of all reporting groups
Age, Continuous	53.7 years STANDARD_DEVIATION 7.02 • n=5 Participants	55.7 years STANDARD_DEVIATION 4.51 • n=7 Participants	48.0 years STANDARD_DEVIATION 8.54 • n=5 Participants	58.77 years STANDARD_DEVIATION 19.01 • n=4 Participants	60.3 years STANDARD_DEVIATION 10.27 • n=21 Participants	63.9 years STANDARD_DEVIATION 8.85 • n=10 Participants	56.6 years STANDARD_DEVIATION 13.96 • n=115 Participants	61.0 years STANDARD_DEVIATION 11.94 • n=24 Participants	60.5 years STANDARD_DEVIATION 11.39 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=24 Participants	8 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants	8 Participants n=10 Participants	6 Participants n=115 Participants	13 Participants n=24 Participants	43 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=24 Participants	6 Participants n=42 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants	8 Participants n=10 Participants	6 Participants n=115 Participants	13 Participants n=24 Participants	45 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants

PRIMARY outcome

Timeframe: 12 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months Any TEAE	100 percentage of participants	100 percentage of participants	88.9 percentage of participants	92.9 percentage of participants	—	—
Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months TEAEs related to the investigational product (IP)	50 percentage of participants	12.5 percentage of participants	11.1 percentage of participants	57.1 percentage of participants	—	—
Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months TEAEs related to administration of the IP	12.5 percentage of participants	25 percentage of participants	11.1 percentage of participants	57.1 percentage of participants	—	—
Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months Serious TEAEs	62.5 percentage of participants	50 percentage of participants	33.3 percentage of participants	64.3 percentage of participants	—	—
Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months Serious TEAEs related to the IP	0 percentage of participants	0 percentage of participants	0 percentage of participants	21.4 percentage of participants	—	—
Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months Serious TEAEs related to IP administration	0 percentage of participants	0 percentage of participants	0 percentage of participants	28.6 percentage of participants	—	—

PRIMARY outcome

Timeframe: 6 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.

Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Length of Cardiovascular-related Hospitalizations at 6 Months	0.3 days Standard Deviation 0.46	1.3 days Standard Deviation 2.55	0.2 days Standard Deviation 0.67	2.1 days Standard Deviation 2.92	—	—

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.

NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest). The MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0. For both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 6: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score Change in NHYA class	-0.8 units on a scale Standard Deviation 0.71	-0.8 units on a scale Standard Deviation 0.89	-0.6 units on a scale Standard Deviation 0.73	-0.2 units on a scale Standard Deviation 0.70	—	—
Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 6: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score Change in MLWHFQ score	-7.6 units on a scale Standard Deviation 20.99	7.9 units on a scale Standard Deviation 27.28	-10.3 units on a scale Standard Deviation 12.21	3.4 units on a scale Standard Deviation 36.00	—	—

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.

The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 6	13.0 meters Standard Deviation 61.40	-59.5 meters Standard Deviation 213.64	1.0 meters Standard Deviation 99.69	-86.6 meters Standard Deviation 164.30	—	—

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.

Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 6	-0.73 mL/kg per minute Standard Deviation 4.88	-1.07 mL/kg per minute Standard Deviation 5.076	-0.43 mL/kg per minute Standard Deviation 0,802	-2.10 mL/kg per minute Standard Deviation 4.462	—	—

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. NT-proBNP data were not available for 1 patient in the MYDICAR high dose group.

NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 6	694.1 pg/mL Standard Deviation 1444.94	2073.1 pg/mL Standard Deviation 4224.22	-13.5 pg/mL Standard Deviation 928.48	5540.0 pg/mL Standard Deviation 11,873.46	—	—

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.

Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 6	0.0 Percentage of blood ejected from the LV Standard Deviation 1.87	-1.5 Percentage of blood ejected from the LV Standard Deviation 6.35	-0.7 Percentage of blood ejected from the LV Standard Deviation 3.76	-2.1 Percentage of blood ejected from the LV Standard Deviation 6.90	—	—

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.

Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) Frm Baseline to Month 6	0.4 mL Standard Deviation 26.16	10.5 mL Standard Deviation 45.91	-9.6 mL Standard Deviation 27.55	18.2 mL Standard Deviation 39.45	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.

Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Length of Cardiovascular-related Hospitalizations at 12 Months	10.1 days Standard Deviation 12.71	7.4 days Standard Deviation 11.80	0.4 days Standard Deviation 1.33	4.5 days Standard Deviation 5.80	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Population: This analysis was performed on the intention to treat population, which included all patients randomized to treatment.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 12: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score Change in NHYA class	-0.1 units on a scale Standard Deviation 0.99	0.1 units on a scale Standard Deviation 0.83	-0.3 units on a scale Standard Deviation 0.71	0.1 units on a scale Standard Deviation 0.73	—	—
Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 12: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score Change in MLWHFQ score	24.4 units on a scale Standard Deviation 37.3	22.5 units on a scale Standard Deviation 32.56	0.1 units on a scale Standard Deviation 23.80	14.7 units on a scale Standard Deviation 34.89	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 12	-167.9 meters Standard Deviation 191.02	-115.9 meters Standard Deviation 226.56	-23.7 meters Standard Deviation 151.08	-120.4 meters Standard Deviation 181.41	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. Peak VO2 data were not available for one patient in the placebo group.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=13 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 12	-5.00 mL/kg per minute Standard Deviation 4.733	-3.31 mL/kg per minute Standard Deviation 5.473	-1.57 mL/kg per minute Standard Deviation 3.677	-2.75 mL/kg per minute Standard Deviation 5.084	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 12	3689.1 pg/mL Standard Deviation 5109.27	8440.4 pg/mL Standard Deviation 11270.44	1756.3 pg/mL Standard Deviation 4331.00	11464.3 pg/mL Standard Deviation 16866.55	—	—

POST_HOC outcome

Timeframe: 12 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.

Incidences of key clinical endpoints as adjudicated by the blinded Clinical Endpoint Committee.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Selected Clinical Outcomes During 12-month Study Period Receipt of left ventricular assist device	0 percentage of participants	12.5 percentage of participants	0 percentage of participants	14.3 percentage of participants	—	—
Phase 2: Selected Clinical Outcomes During 12-month Study Period Fatal cardiovascular event	12.5 percentage of participants	0 percentage of participants	0 percentage of participants	7.1 percentage of participants	—	—
Phase 2: Selected Clinical Outcomes During 12-month Study Period Worsening heart failure	50.0 percentage of participants	37.5 percentage of participants	22.2 percentage of participants	50.0 percentage of participants	—	—
Phase 2: Selected Clinical Outcomes During 12-month Study Period Myocardial infarction	0 percentage of participants	0 percentage of participants	0 percentage of participants	14.3 percentage of participants	—	—
Phase 2: Selected Clinical Outcomes During 12-month Study Period Heart failure-related hospitalization	50.0 percentage of participants	37.5 percentage of participants	22.2 percentage of participants	42.9 percentage of participants	—	—
Phase 2: Selected Clinical Outcomes During 12-month Study Period Silent myocardial infarction	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—
Phase 2: Selected Clinical Outcomes During 12-month Study Period Heart transplant	0 percentage of participants	25.0 percentage of participants	11.1 percentage of participants	7.1 percentage of participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 12	-6.5 Percentage of blood ejected from the LV Standard Deviation 7.26	-5.6 Percentage of blood ejected from the LV Standard Deviation 10.52	0.3 Percentage of blood ejected from the LV Standard Deviation 8.87	-2.5 Percentage of blood ejected from the LV Standard Deviation 9.96	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Population: This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=8 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=9 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) From Baseline to Month 12	40.7 mL Standard Deviation 59.79	66.8 mL Standard Deviation 103.12	9.9 mL Standard Deviation 49.27	37.7 mL Standard Deviation 69.09	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 months

Population: Includes all participants enrolled in the Phase 1 or Phase 2 trial. Events occurring after early termination are listed under long-term follow-up. The number of "CV deaths in long-term follow-up" for the placebo group is greater than the number of "Deaths after 12 months," as 2 deaths occurred within 12 months but after early termination.

All subject deaths that occurred during the 12-month study or the 24-month follow-up in subjects enrolled in either the Phase 1 or Phase 2 trial. Events occurring after early termination from the trial are listed as occurring during long-term follow-up, but may have been within 12 months. Specifically, two cardiovascular (CV) deaths in placebo subjects occurred following early study termination, but within 12 months of study initiation. These deaths are therefore included under "Deaths within 12 months" but also listed as "Cardiovascular deaths in long-term follow-up." Accordingly, the number of "Cardiovascular deaths in long-term follow-up" for the placebo group is greater than the number of "Deaths after 12 months," as 2 of the deaths occurred within 12 months but after early termination.

Outcome measures

Outcome measures
Measure	MYDICAR® Low Dose n=3 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=11 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=11 Participants Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=12 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.	All MYDICAR® n=37 Participants All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.	Placebo n=14 Participants Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Phase 1 and Phase 2: All Subject Deaths Through 36 Months Cardiovascular deaths in long-term follow-up	1 participants	2 participants	1 participants	2 participants	6 participants	4 participants
Phase 1 and Phase 2: All Subject Deaths Through 36 Months Deaths within 12 months	0 participants	2 participants	0 participants	0 participants	2 participants	3 participants
Phase 1 and Phase 2: All Subject Deaths Through 36 Months Deaths after 12 months	1 participants	2 participants	3 participants	2 participants	8 participants	3 participants
Phase 1 and Phase 2: All Subject Deaths Through 36 Months Cardiovascular deaths on study	0 participants	2 participants	0 participants	0 participants	2 participants	1 participants
Phase 1 and Phase 2: All Subject Deaths Through 36 Months All deaths during 36 months	1 participants	4 participants	3 participants	2 participants	10 participants	6 participants

Adverse Events

MYDICAR® Very Low Dose

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

MYDICAR® Low Dose

Serious events: 6 serious events

Other events: 11 other events

Deaths: 0 deaths

MYDICAR® Mid Dose

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

MYDICAR® High Dose

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MYDICAR® Very Low Dose n=3 participants at risk Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Low Dose n=11 participants at risk Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=11 participants at risk Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=12 participants at risk Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 participants at risk Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Cardiac disorders Cardiac failure	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	36.4% 4/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	16.7% 2/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	21.4% 3/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Cardiac failure congestive	33.3% 1/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	21.4% 3/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Cardiac failure acute	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Acute myocardial infarction	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Arrhythmia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Cardiorenal syndrome	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Chest pain	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Chest discomfort	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Pyrexia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Gastrointestinal disorders Melaena	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Brain stem stroke	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Syncope	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Transient ischaemic attack	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Pneumonia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Pneumonia staphylococcal	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Injury, poisoning and procedural complications Overdose	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Surgical and medical procedures Catheterization cardiac	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Surgical and medical procedures Heart transplant	33.3% 1/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Eye disorders Vision blurred	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Colonoscopy	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Renal and urinary disorders Renal failure acute	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Angina unstable	33.3% 1/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Cardiogenic shock	33.3% 1/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Sudden death	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Diabetes mellitus	33.3% 1/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.

Other adverse events

Other adverse events
Measure	MYDICAR® Very Low Dose n=3 participants at risk Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Low Dose n=11 participants at risk Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® Mid Dose n=11 participants at risk Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.	MYDICAR® High Dose n=12 participants at risk Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \[AAV1\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.	Placebo n=14 participants at risk Single dose of placebo administered by antegrade epicardial coronary artery infusion.
Injury, poisoning and procedural complications Eye injury	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	27.3% 3/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Injury, poisoning and procedural complications Head injury	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Injury, poisoning and procedural complications Mouth injury	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Injury, poisoning and procedural complications Post procedural discharge	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Blood bilirubin increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Blood creatinine phosphokinase increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Injury, poisoning and procedural complications Excoriation	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Angina pectoris	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Arrhythmia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Cardiac aneurysm	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Cardiac failure	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	16.7% 2/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	21.4% 3/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Cardiac failure congestive	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	27.3% 3/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Cardiogenic shock	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Extrasystoles	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Intracardiac thrombus	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Palpitations	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Tachycardia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Ventricular fibrillation	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	25.0% 3/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Cardiac disorders Ventricular tachycardia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	16.7% 2/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Ear and labyrinth disorders External ear disorder	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Endocrine disorders Hypothyroidism	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Eye disorders Vision blurred	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Gastrointestinal disorders Ascites	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Gastrointestinal disorders Constipation	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	28.6% 4/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Gastrointestinal disorders Gastric ulcer	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Gastrointestinal disorders Nausea	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Catheter site hematoma	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Catheter site hemorrhage	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Chest discomfort	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Chest pain	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	25.0% 3/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Chills	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Fatigue	33.3% 1/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	27.3% 3/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	16.7% 2/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	28.6% 4/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Feeling jittery	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Gait disturbance	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Influenza like illness	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Infusion site pain	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Edema	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Edema peripheral	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Puncture site pain	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Pyrexia	33.3% 1/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
General disorders Venipuncture site thrombosis	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Hepatobiliary disorders Jaundice	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Bronchitis	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Candidiasis	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Cellulitis	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Central line infection	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Gastric ulcer Helicobacter	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Herpes zoster	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Influenza	33.3% 1/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Pneumonia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Respiratory tract infection	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Sinusitis	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	27.3% 3/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Infections and infestations Viral infection	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	16.7% 2/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Blood creatinine phosphokinase MB increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Blood magnesium decreased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Blood triglycerides increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Blood uric acid increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Carcinoembryonic antigen increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Gallop rhythm present	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Hepatic enzyme increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations International normalized ratio increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Liver function test abnormal	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Mean cell volume increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Muscle enzyme increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Prostatic specific antigen increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Transaminases increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Troponin increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Vitamin D decreased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Investigations Weight increased	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Fluid overload	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	16.7% 2/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Fluid retention	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Gout	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	28.6% 4/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Hyperlipidemia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Hypervolemia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	27.3% 3/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Hypovolemia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Musculoskeletal and connective tissue disorders Bone disorder	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Musculoskeletal and connective tissue disorders Muscle spasms	33.3% 1/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Asterixis	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Dizziness	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	28.6% 4/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Dizziness postural	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Headache	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Hepatic encephalopathy	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Hypoesthesia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Neurological symptom	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Nystagmus	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Paresthesia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Restless leg syndrome	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Somnolence	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Nervous system disorders Syncope	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Psychiatric disorders Alcoholism	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Psychiatric disorders Anxiety	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Psychiatric disorders Bruxism	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Psychiatric disorders Depression	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	21.4% 3/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Psychiatric disorders Insomnia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Psychiatric disorders Mental status changes	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Psychiatric disorders Somnambulism	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Renal and urinary disorders Azotemia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Renal and urinary disorders Hematuria	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Renal and urinary disorders Renal failure	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Renal and urinary disorders Renal failure acute	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Renal and urinary disorders Renal impairment	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Reproductive system and breast disorders Breast disorder	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Reproductive system and breast disorders Gynecomastia	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Reproductive system and breast disorders Variocele	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	16.7% 2/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Dyspnea exertional	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Orthopnea	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	8.3% 1/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Sleep apnea syndrome	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	18.2% 2/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Skin and subcutaneous tissue disorders Hemorrhage subcutaneous	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Skin and subcutaneous tissue disorders Rash generalized	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Surgical and medical procedures Cataract operation	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Vascular disorders Hematoma	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	14.3% 2/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Vascular disorders Hypertension	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	0.00% 0/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.
Vascular disorders Hypotension	0.00% 0/3 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	9.1% 1/11 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	16.7% 2/12 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.	7.1% 1/14 • All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit. These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.

Additional Information

Jeffrey J. Rudy, Vice President

Celladon Corporation

Phone: 1 858-366-4288

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60