Trial Outcomes & Findings for Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA) (NCT NCT03779841)

NCT ID: NCT03779841

Last Updated: 2024-05-14

Results Overview

At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 323 participants
• Primary outcome timeframe: First 30 days following the initial intensive care unit (ICU) admission date after open-chest cardiac surgery.
• Results posted on: 2024-05-14

Participant Flow

A total of 323 subjects were randomized, of which 319 received study drug (Safety Population).

Participant milestones

Measure	Placebo Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Randomized Population STARTED	108	106	109
Randomized Population COMPLETED	105	105	109
Randomized Population NOT COMPLETED	3	1	0
Treated (Safety) Population STARTED	105	105	109
Treated (Safety) Population COMPLETED	94	87	93
Treated (Safety) Population NOT COMPLETED	11	18	16

Reasons for withdrawal

Measure	Placebo Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Randomized Population Did Not Receive Treatment	3	1	0
Treated (Safety) Population Adverse Event	1	1	0
Treated (Safety) Population Withdrawal by Subject	4	8	6
Treated (Safety) Population Lost to Follow-up	5	9	8
Treated (Safety) Population Death	1	0	2

Baseline Characteristics

Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA)

Baseline characteristics by cohort

Measure	Placebo n=105 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=105 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=109 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	Total n=319 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants	42 Participants n=7 Participants	45 Participants n=5 Participants	130 Participants n=4 Participants
Age, Categorical >=65 years	62 Participants n=5 Participants	63 Participants n=7 Participants	64 Participants n=5 Participants	189 Participants n=4 Participants
Age, Continuous	66.8 years STANDARD_DEVIATION 6.76 • n=5 Participants	66.8 years STANDARD_DEVIATION 6.54 • n=7 Participants	67.2 years STANDARD_DEVIATION 7.01 • n=5 Participants	66.9 years STANDARD_DEVIATION 6.76 • n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	17 Participants n=7 Participants	22 Participants n=5 Participants	53 Participants n=4 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	88 Participants n=7 Participants	87 Participants n=5 Participants	266 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=5 Participants	97 Participants n=7 Participants	103 Participants n=5 Participants	299 Participants n=4 Participants
Ethnicity (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
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
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 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
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	102 Participants n=5 Participants	102 Participants n=7 Participants	105 Participants n=5 Participants	309 Participants n=4 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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Type of Surgery Isolated Coronary Artery Bypass Graft (CABG) Surgery	65 Participants n=5 Participants	68 Participants n=7 Participants	70 Participants n=5 Participants	203 Participants n=4 Participants
Type of Surgery Valve only Surgery	27 Participants n=5 Participants	24 Participants n=7 Participants	27 Participants n=5 Participants	78 Participants n=4 Participants
Type of Surgery CABG and Valve Surgery	13 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	38 Participants n=4 Participants

PRIMARY outcome

Timeframe: First 30 days following the initial intensive care unit (ICU) admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery	46.1 percentage of participants	36.5 percentage of participants	47.2 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

The proportion of time an individual is in AF (atrial fibrillation or atrial flutter) during a monitoring period (expressed as a percentage) calculated as (the total time spent in AF during the first 30 days post-surgery divided by the total time of analyzable data obtained from the ECG patch during the first 30 days post-surgery) multiplied by 100. The calculation excludes continuous AF episodes < 30 seconds in duration.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Time Spent in Atrial Fibrillation or Atrial Flutter (AF Burden) During the First 30 Days Post-surgery	4.84 percentage of time Standard Deviation 14.898	4.41 percentage of time Standard Deviation 14.976	5.45 percentage of time Standard Deviation 15.821

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least 1 event of symptomatic AF (atrial fibrillation or atrial flutter) (symptoms occurring within 2 hours of an AF episode). For symptomatic AF, symptoms that occur in the interval that starts two hours prior to the onset of the AF episode and ends two hours after the conclusion of the AF episode will meet the definition of "within 2 hours of an AF episode".

AF episode ≥ 30 seconds.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Event of Symptomatic AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery	13.7 percentage of participants	13.5 percentage of participants	13.2 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

Amount of time (days) to first AF (atrial fibrillation or atrial flutter) occurrence defined by first episode of AF lasting for ≥ 30 seconds.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Time to First Occurrence of AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery	NA Days Interval 9.1 to Insufficient number of participants with events	NA Days Insufficient number of participants with events	NA Days Interval 13.2 to Insufficient number of participants with events

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 2 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 2 Minutes During the First 30 Days Post-surgery	45.1 percentage of participants	35.6 percentage of participants	46.2 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 5 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 5 Minutes During the First 30 Days Post-surgery	44.1 percentage of participants	34.6 percentage of participants	46.2 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Minutes During the First 30 Days Post-surgery	43.1 percentage of participants	33.7 percentage of participants	45.3 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Minutes During the First 30 Days Post-surgery	38.2 percentage of participants	30.8 percentage of participants	39.6 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 1 hour documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 1 Hour During the First 30 Days Post-surgery	37.3 percentage of participants	29.8 percentage of participants	37.7 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 4 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 4 Hours During the First 30 Days Post-surgery	32.4 percentage of participants	24.0 percentage of participants	26.4 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Hours During the First 30 Days Post-surgery	25.5 percentage of participants	22.1 percentage of participants	20.8 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 12 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 12 Hours During the First 30 Days Post-surgery	15.7 percentage of participants	14.4 percentage of participants	17.0 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 24 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 24 Hours During the First 30 Days Post-surgery	9.8 percentage of participants	6.7 percentage of participants	12.3 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous atrial fibrillation (excluding atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous Atrial Fibrillation (Excluding Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery	43.1 percentage of participants	33.7 percentage of participants	42.5 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous atrial flutter sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous Atrial Flutter Episode ≥ 30 Seconds During the First 30 Days Post-surgery	12.7 percentage of participants	8.7 percentage of participants	15.1 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous Atrial Tachycardia Episode (Defined as the Duration of the Longest Supraventricular Tachycardia [SVT] Run) ≥ 30 Seconds During the First 30 Days Post-surgery	2.9 percentage of participants	11.5 percentage of participants	7.5 percentage of participants

SECONDARY outcome

Timeframe: First 30 days following the initial ICU admission date after open-chest cardiac surgery.

Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.

At least one episode of continuous atrial fibrillation or atrial flutter or atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.

Outcome measures

Measure	Placebo n=102 Participants Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=104 Participants Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=106 Participants Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Percentage of Participants With at Least 1 Continuous Episode of Either Atrial Fibrillation or Atrial Flutter or Atrial Tachycardia ≥ 30 Seconds During the First 30 Days Post-surgery	48.0 percentage of participants	41.3 percentage of participants	51.9 percentage of participants

Adverse Events

Placebo

Serious events: 36 serious events

Other events: 86 other events

Deaths: 1 deaths

AGN-151607 (125 U)

Serious events: 38 serious events

Other events: 84 other events

Deaths: 0 deaths

AGN-151607 (250 U)

Serious events: 28 serious events

Other events: 94 other events

Deaths: 2 deaths

Serious adverse events

Measure	Placebo n=105 participants at risk Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=105 participants at risk Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=109 participants at risk Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Blood and lymphatic system disorders BLOOD LOSS ANAEMIA	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Blood and lymphatic system disorders COAGULOPATHY	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Blood and lymphatic system disorders THROMBOCYTOSIS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders ACUTE LEFT VENTRICULAR FAILURE	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders AORTIC VALVE INCOMPETENCE	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders ATRIAL FIBRILLATION	5.7% 6/105 • Number of events 7 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	5.7% 6/105 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	3.7% 4/109 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders ATRIAL FLUTTER	4.8% 5/105 • Number of events 5 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	4.6% 5/109 • Number of events 5 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.8% 2/109 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders BRADYCARDIA	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.8% 2/109 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders CARDIAC ARREST	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders CARDIAC FAILURE	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders CARDIAC FAILURE ACUTE	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders CARDIOGENIC SHOCK	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders CORONARY ARTERY PERFORATION	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders NODAL RHYTHM	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders PERICARDIAL EFFUSION	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders PERICARDITIS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Eye disorders DIPLOPIA	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.8% 2/109 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Gastrointestinal disorders AORTO-OESOPHAGEAL FISTULA	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Gastrointestinal disorders DIARRHOEA	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Gastrointestinal disorders DYSPHAGIA	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Gastrointestinal disorders ILEUS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Gastrointestinal disorders MELAENA	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
General disorders ASTHENIA	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
General disorders PYREXIA	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations APPENDICITIS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations BACTERAEMIA	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations BRONCHITIS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations CELLULITIS	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations COLONIC ABSCESS	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations COVID-19	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations COVID-19 PNEUMONIA	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations DIVERTICULITIS	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations ENDOCARDITIS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations MEDIASTINITIS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations OSTEOMYELITIS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations PNEUMONIA	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations SEPSIS	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations WOUND INFECTION	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Injury, poisoning and procedural complications CORONARY SINUS INJURY	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Injury, poisoning and procedural complications FALL	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Injury, poisoning and procedural complications PERIPROCEDURAL MYOCARDIAL INFARCTION	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Injury, poisoning and procedural complications POSTOPERATIVE ILEUS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Injury, poisoning and procedural complications PROCEDURAL HAEMORRHAGE	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Injury, poisoning and procedural complications TRANSFUSION-RELATED ACUTE LUNG INJURY	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Injury, poisoning and procedural complications VASCULAR GRAFT OCCLUSION	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Injury, poisoning and procedural complications VASCULAR PROCEDURE COMPLICATION	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Investigations ELECTROENCEPHALOGRAM ABNORMAL	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Investigations HAEMOGLOBIN DECREASED	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Metabolism and nutrition disorders LACTIC ACIDOSIS	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Nervous system disorders AMYOTROPHIC LATERAL SCLEROSIS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Nervous system disorders BELL'S PALSY	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Nervous system disorders CEREBRAL ISCHAEMIA	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Nervous system disorders CEREBROVASCULAR ACCIDENT	2.9% 3/105 • Number of events 4 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Nervous system disorders DIZZINESS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Nervous system disorders ENCEPHALOPATHY	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Nervous system disorders FACIAL PARALYSIS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Nervous system disorders LOSS OF CONSCIOUSNESS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Nervous system disorders MYASTHENIA GRAVIS	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Nervous system disorders SYNCOPE	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	2.9% 3/105 • Number of events 3 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Psychiatric disorders MENTAL STATUS CHANGES	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Renal and urinary disorders ACUTE KIDNEY INJURY	1.9% 2/105 • Number of events 3 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Renal and urinary disorders HAEMATURIA	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Renal and urinary disorders URINARY RETENTION	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders ASPIRATION	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders DIAPHRAGMATIC PARALYSIS	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders HAEMOTHORAX	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	2.9% 3/105 • Number of events 3 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	2.9% 3/105 • Number of events 3 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	4.8% 5/105 • Number of events 5 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.8% 2/109 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Vascular disorders AORTIC PERFORATION	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Vascular disorders DEEP VEIN THROMBOSIS	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Vascular disorders HAEMATOMA	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Vascular disorders HAEMORRHAGE	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Vascular disorders HYPERTENSION	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Vascular disorders INTERMITTENT CLAUDICATION	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Vascular disorders ORTHOSTATIC HYPOTENSION	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Vascular disorders SHOCK HAEMORRHAGIC	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.92% 1/109 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Vascular disorders THROMBOSIS	0.00% 0/105 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.00% 0/109 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.

Other adverse events

Measure	Placebo n=105 participants at risk Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (125 U) n=105 participants at risk Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.	AGN-151607 (250 U) n=109 participants at risk Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Blood and lymphatic system disorders ANAEMIA	25.7% 27/105 • Number of events 28 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	18.1% 19/105 • Number of events 20 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	27.5% 30/109 • Number of events 30 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders ATRIAL FIBRILLATION	30.5% 32/105 • Number of events 38 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	29.5% 31/105 • Number of events 37 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	32.1% 35/109 • Number of events 40 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders ATRIAL FLUTTER	5.7% 6/105 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	4.8% 5/105 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	6.4% 7/109 • Number of events 7 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders BRADYCARDIA	3.8% 4/105 • Number of events 4 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	6.7% 7/105 • Number of events 8 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	3.7% 4/109 • Number of events 4 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders PALPITATIONS	6.7% 7/105 • Number of events 10 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	3.8% 4/105 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	5.5% 6/109 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders SINUS TACHYCARDIA	6.7% 7/105 • Number of events 8 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.8% 2/109 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Cardiac disorders TACHYCARDIA	3.8% 4/105 • Number of events 4 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	3.8% 4/105 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	11.0% 12/109 • Number of events 12 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Gastrointestinal disorders CONSTIPATION	9.5% 10/105 • Number of events 10 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	6.7% 7/105 • Number of events 9 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	5.5% 6/109 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Gastrointestinal disorders NAUSEA	23.8% 25/105 • Number of events 25 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	23.8% 25/105 • Number of events 27 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	26.6% 29/109 • Number of events 30 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Gastrointestinal disorders VOMITING	3.8% 4/105 • Number of events 4 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	6.4% 7/109 • Number of events 7 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
General disorders FATIGUE	6.7% 7/105 • Number of events 8 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	2.9% 3/105 • Number of events 3 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	4.6% 5/109 • Number of events 5 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
General disorders OEDEMA PERIPHERAL	12.4% 13/105 • Number of events 15 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	9.5% 10/105 • Number of events 11 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	9.2% 10/109 • Number of events 10 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
General disorders PYREXIA	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	7.6% 8/105 • Number of events 8 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	4.6% 5/109 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations COVID-19	4.8% 5/105 • Number of events 5 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	9.5% 10/105 • Number of events 12 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	5.5% 6/109 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Infections and infestations URINARY TRACT INFECTION	3.8% 4/105 • Number of events 4 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	5.7% 6/105 • Number of events 7 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	5.5% 6/109 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Injury, poisoning and procedural complications PROCEDURAL PAIN	19.0% 20/105 • Number of events 20 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	19.0% 20/105 • Number of events 21 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	19.3% 21/109 • Number of events 21 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Injury, poisoning and procedural complications VASOPLEGIA SYNDROME	2.9% 3/105 • Number of events 3 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	4.8% 5/105 • Number of events 5 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	11.9% 13/109 • Number of events 13 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Metabolism and nutrition disorders HYPERGLYCAEMIA	13.3% 14/105 • Number of events 16 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	16.2% 17/105 • Number of events 19 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	15.6% 17/109 • Number of events 17 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Metabolism and nutrition disorders HYPERVOLAEMIA	17.1% 18/105 • Number of events 19 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	22.9% 24/105 • Number of events 24 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	21.1% 23/109 • Number of events 23 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Metabolism and nutrition disorders HYPOKALAEMIA	2.9% 3/105 • Number of events 3 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	2.9% 3/105 • Number of events 3 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	8.3% 9/109 • Number of events 9 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	4.8% 5/105 • Number of events 5 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	5.7% 6/105 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	6.4% 7/109 • Number of events 7 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	11.4% 12/105 • Number of events 12 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	10.5% 11/105 • Number of events 12 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	8.3% 9/109 • Number of events 9 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Nervous system disorders DIZZINESS	7.6% 8/105 • Number of events 10 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	3.8% 4/105 • Number of events 4 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	4.6% 5/109 • Number of events 5 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Psychiatric disorders ANXIETY	5.7% 6/105 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	2.9% 3/105 • Number of events 4 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	4.6% 5/109 • Number of events 5 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Psychiatric disorders DELIRIUM	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	5.5% 6/109 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Psychiatric disorders INSOMNIA	15.2% 16/105 • Number of events 16 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	16.2% 17/105 • Number of events 17 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	11.0% 12/109 • Number of events 12 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	11.4% 12/105 • Number of events 12 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	10.5% 11/105 • Number of events 11 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	16.5% 18/109 • Number of events 20 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders COUGH	5.7% 6/105 • Number of events 7 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	2.9% 3/105 • Number of events 3 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	6.4% 7/109 • Number of events 7 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	12.4% 13/105 • Number of events 19 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	2.9% 3/105 • Number of events 4 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	11.9% 13/109 • Number of events 13 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	13.3% 14/105 • Number of events 15 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	9.5% 10/105 • Number of events 11 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	20.2% 22/109 • Number of events 24 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.95% 1/105 • Number of events 1 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	6.7% 7/105 • Number of events 7 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	5.5% 6/109 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Skin and subcutaneous tissue disorders DERMATITIS CONTACT	4.8% 5/105 • Number of events 5 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	1.9% 2/105 • Number of events 2 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	5.5% 6/109 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Vascular disorders HYPERTENSION	7.6% 8/105 • Number of events 9 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	6.7% 7/105 • Number of events 7 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	5.5% 6/109 • Number of events 6 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.
Vascular disorders HYPOTENSION	14.3% 15/105 • Number of events 18 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	9.5% 10/105 • Number of events 10 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.	15.6% 17/109 • Number of events 20 • The length of this study was up to 367 days post single dose study treatment, plus up to 28 days before the first study day (randomization, Day 1). Of the 323 subjects enrolled and included in the All-Cause Mortality table, 4 did not receive treatment and, therefore, did not go beyond the 28-Day screening period. The median time followed for the 319 subjects who received a single treatment of Placebo, AGN-151607 125 Units, or AGN-151607 250 Units was 371.0, 372.0 and 371.0 days, respectively.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: abbvieclinicaltrials@abbvie.com

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER