Trial Outcomes & Findings for Veterans Individual Placement and Support Towards Advancing Recovery (NCT NCT01817712)

NCT ID: NCT01817712

Last Updated: 2019-02-19

Results Overview

The primary outcome will be achievement of a "steady worker" status, defined as obtaining and maintaining competitive employment for at least 50% of the active follow-up period (i.e., greater than or equal to 39 weeks).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 541 participants
• Primary outcome timeframe: 78 weeks
• Results posted on: 2019-02-19

Participant Flow

Participant milestones

Measure	1 Individual Placement and Support (IPS) Individual Placement \& Support: IPS uses an integrated "place-train" approach to help people obtain and maintain community-based competitive employment in their chosen occupation.	VA Transitional Work Program (TWP) VA Transitional Work Program: The long-standing approach to vocational rehabilitation in VHA and state programs is the "train-place" or "stepwise" model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role.
Overall Study STARTED	271	270
Overall Study COMPLETED	250	240
Overall Study NOT COMPLETED	21	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Time at Current Residence was reported for participants who indicated adequate housing

Baseline characteristics by cohort

Measure	Individual Placement and Support (IPS) n=271 Participants Individual Placement \& Support: IPS uses an integrated "place-train" approach to help people obtain and maintain community-based competitive employment in their chosen occupation.	VA Transitional Work Program (TWP) n=270 Participants VA Transitional Work Program: The long-standing approach to vocational rehabilitation in VHA and state programs is the "train-place" or "stepwise" model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role.	Total n=541 Participants Total of all reporting groups
Age, Continuous	42.5 Years STANDARD_DEVIATION 10.7 • n=271 Participants	41.9 Years STANDARD_DEVIATION 11.2 • n=270 Participants	42.2 Years STANDARD_DEVIATION 10.9 • n=541 Participants
Sex: Female, Male Female	47 Participants n=271 Participants	52 Participants n=270 Participants	99 Participants n=541 Participants
Sex: Female, Male Male	224 Participants n=271 Participants	218 Participants n=270 Participants	442 Participants n=541 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	43 Participants n=271 Participants	47 Participants n=270 Participants	90 Participants n=541 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	228 Participants n=271 Participants	223 Participants n=270 Participants	451 Participants n=541 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=271 Participants	0 Participants n=270 Participants	0 Participants n=541 Participants
Race/Ethnicity, Customized White	138 Participants n=271 Participants	136 Participants n=270 Participants	274 Participants n=541 Participants
Race/Ethnicity, Customized African American	115 Participants n=271 Participants	110 Participants n=270 Participants	225 Participants n=541 Participants
Race/Ethnicity, Customized All Other	32 Participants n=271 Participants	36 Participants n=270 Participants	68 Participants n=541 Participants
Race/Ethnicity, Customized More than one race	13 Participants n=271 Participants	12 Participants n=270 Participants	25 Participants n=541 Participants
Region of Enrollment United States	271 Participants n=271 Participants	270 Participants n=270 Participants	541 Participants n=541 Participants
Education Level Less than High School	1 Participants n=271 Participants	4 Participants n=270 Participants	5 Participants n=541 Participants
Education Level High School Diploma	53 Participants n=271 Participants	39 Participants n=270 Participants	92 Participants n=541 Participants
Education Level Some College Credit	106 Participants n=271 Participants	118 Participants n=270 Participants	224 Participants n=541 Participants
Education Level Associate's Degree	55 Participants n=271 Participants	35 Participants n=270 Participants	90 Participants n=541 Participants
Education Level Bachelor's Degree	40 Participants n=271 Participants	57 Participants n=270 Participants	97 Participants n=541 Participants
Education Level Master's or Doctoral Degree	16 Participants n=271 Participants	17 Participants n=270 Participants	33 Participants n=541 Participants
Housing Status Single Family Home	122 Participants n=271 Participants	121 Participants n=270 Participants	243 Participants n=541 Participants
Housing Status Townhouse/Apartment/Condo	91 Participants n=271 Participants	94 Participants n=270 Participants	185 Participants n=541 Participants
Housing Status Other Housing	16 Participants n=271 Participants	20 Participants n=270 Participants	36 Participants n=541 Participants
Housing Status Inaquate Housing	42 Participants n=271 Participants	35 Participants n=270 Participants	77 Participants n=541 Participants
Inadequate Housing Status Transitional Housing	23 Participants n=271 Participants	23 Participants n=270 Participants	46 Participants n=541 Participants
Inadequate Housing Status Homeless Shelter or other	19 Participants n=271 Participants	12 Participants n=270 Participants	31 Participants n=541 Participants
Years of Homelessness	1.9 Years STANDARD_DEVIATION 1.7 • n=271 Participants	1.9 Years STANDARD_DEVIATION 2.8 • n=270 Participants	1.9 Years STANDARD_DEVIATION 2.0 • n=541 Participants
Time at Current Residence	3.6 Years STANDARD_DEVIATION 5.7 • n=229 Participants • The Time at Current Residence was reported for participants who indicated adequate housing	3.7 Years STANDARD_DEVIATION 6.2 • n=235 Participants • The Time at Current Residence was reported for participants who indicated adequate housing	3.6 Years STANDARD_DEVIATION 5.9 • n=464 Participants • The Time at Current Residence was reported for participants who indicated adequate housing
Marital Status Married	89 Participants n=271 Participants	84 Participants n=270 Participants	173 Participants n=541 Participants
Marital Status Divorced	82 Participants n=271 Participants	79 Participants n=270 Participants	161 Participants n=541 Participants
Marital Status Never Married	68 Participants n=271 Participants	67 Participants n=270 Participants	135 Participants n=541 Participants
Marital Status Separated/Cohabitating/widowed	32 Participants n=271 Participants	40 Participants n=270 Participants	72 Participants n=541 Participants
Length of current unemployment	2.7 Years STANDARD_DEVIATION 3.5 • n=271 Participants	2.9 Years STANDARD_DEVIATION 4.1 • n=270 Participants	2.8 Years STANDARD_DEVIATION 3.8 • n=541 Participants
Duration of longest job in lifetime	8.3 years STANDARD_DEVIATION 5.8 • n=271 Participants	8.7 years STANDARD_DEVIATION 6.4 • n=270 Participants	8.5 years STANDARD_DEVIATION 6.1 • n=541 Participants
Current Major Depressive Episode	87 Participants n=271 Participants	83 Participants n=270 Participants	170 Participants n=541 Participants
Past Major Depressive Episode	183 Participants n=271 Participants	173 Participants n=270 Participants	356 Participants n=541 Participants
Current Agoraphobia	64 Participants n=271 Participants	59 Participants n=270 Participants	123 Participants n=541 Participants
Current Panic Disorder	37 Participants n=271 Participants	33 Participants n=270 Participants	70 Participants n=541 Participants
Social Anxiety Disorder (generalized)	35 Participants n=271 Participants	28 Participants n=270 Participants	63 Participants n=541 Participants
Alcohol Use disorder past 12 months	54 Participants n=271 Participants	78 Participants n=270 Participants	132 Participants n=541 Participants
Non-alcohol use disorder past 12 months	47 Participants n=271 Participants	40 Participants n=270 Participants	87 Participants n=541 Participants
Duration of PTSD	13.3 years STANDARD_DEVIATION 11.6 • n=271 Participants	13.4 years STANDARD_DEVIATION 11.3 • n=270 Participants	13.3 years STANDARD_DEVIATION 11.4 • n=541 Participants
Total CAPS-IV lifetime	84.1 units on a scale STANDARD_DEVIATION 18.9 • n=271 Participants	84.8 units on a scale STANDARD_DEVIATION 18.3 • n=270 Participants	84.5 units on a scale STANDARD_DEVIATION 18.6 • n=541 Participants
Current (last month) PTSD Checklist (PCL-5)	46.2 units on a scale STANDARD_DEVIATION 15.8 • n=271 Participants	45.1 units on a scale STANDARD_DEVIATION 17.0 • n=270 Participants	45.6 units on a scale STANDARD_DEVIATION 16.4 • n=541 Participants
PTSD Checklist (PCL-5) at current diagnostic threshold	209 Participants n=271 Participants	204 Participants n=270 Participants	413 Participants n=541 Participants
PCL-5 Current Severity Very Mild (0-18)	14 Participants n=271 Participants	20 Participants n=270 Participants	34 Participants n=541 Participants
PCL-5 Current Severity Mild (19-37)	64 Participants n=271 Participants	60 Participants n=270 Participants	124 Participants n=541 Participants
PCL-5 Current Severity Moderate (38-59)	128 Participants n=271 Participants	138 Participants n=270 Participants	266 Participants n=541 Participants
PCL-5 Current Severity Severe (60-80)	63 Participants n=271 Participants	49 Participants n=270 Participants	112 Participants n=541 Participants

PRIMARY outcome

Timeframe: 78 weeks

The primary outcome will be achievement of a "steady worker" status, defined as obtaining and maintaining competitive employment for at least 50% of the active follow-up period (i.e., greater than or equal to 39 weeks).

Outcome measures

Measure	Individual Placement and Support (IPS) n=271 Participants Individual Placement \& Support: IPS uses an integrated "place-train" approach to help people obtain and maintain community-based competitive employment in their chosen occupation.	VA Transitional Work Program (TWP) n=270 Participants VA Transitional Work Program: The long-standing approach to vocational rehabilitation in VHA and state programs is the "train-place" or "stepwise" model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role.
Number of Participants Who Obtained and Maintained Competitive Employment for at Least 50% of the Active Follow-up Period	105 Participants	63 Participants

SECONDARY outcome

Timeframe: Weekly for 78 weeks

Cumulative Gross Income is collected using the Employment Calendar source document and Employment Calendar Reconciliation case report form used for the primary outcome ascertainment. When possible, the CRC verifies income earned by reviewing paycheck stubs that the participant is instructed to maintain with the Employment Calendar.

Outcome measures

Measure	Individual Placement and Support (IPS) n=271 Participants Individual Placement \& Support: IPS uses an integrated "place-train" approach to help people obtain and maintain community-based competitive employment in their chosen occupation.	VA Transitional Work Program (TWP) n=270 Participants VA Transitional Work Program: The long-standing approach to vocational rehabilitation in VHA and state programs is the "train-place" or "stepwise" model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role.
Cumulative Gross Income	7290 Dollars Interval 0.0 to 23174.0	1886 Dollars Interval 0.0 to 17167.0

SECONDARY outcome

Timeframe: 18-months (Change from baseline)

PTSD Symptoms are assessed every three months during the follow-up period using the self-report PTSD Checklist (PCL-5) that the participant completes during the follow-up visits. Range of values 0-80 (higher score is worse).

Outcome measures

Measure	Individual Placement and Support (IPS) n=271 Participants Individual Placement \& Support: IPS uses an integrated "place-train" approach to help people obtain and maintain community-based competitive employment in their chosen occupation.	VA Transitional Work Program (TWP) n=270 Participants VA Transitional Work Program: The long-standing approach to vocational rehabilitation in VHA and state programs is the "train-place" or "stepwise" model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role.
Change in PCL-5 Score of PTSD Symptoms	-3.66 units on a scale Interval -6.09 to -1.23	-0.82 units on a scale Interval -3.24 to 1.59

Adverse Events

Individual Placement and Support (IPS)

Serious events: 63 serious events

Other events: 36 other events

Deaths: 3 deaths

VA Transitional Work Program (TWP)

Serious events: 64 serious events

Other events: 40 other events

Deaths: 2 deaths

Serious adverse events

Measure	Individual Placement and Support (IPS) n=271 participants at risk Individual Placement \& Support: IPS uses an integrated "place-train" approach to help people obtain and maintain community-based competitive employment in their chosen occupation.	VA Transitional Work Program (TWP) n=270 participants at risk VA Transitional Work Program: The long-standing approach to vocational rehabilitation in VHA and state programs is the "train-place" or "stepwise" model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role.
Cardiac disorders Acute coronary syndrome	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Cardiac disorders Bradycardia	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Cardiac disorders Cardiac disorder	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Cardiac disorders Myocardial infarction	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Cardiac disorders Pericarditis	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Cardiac disorders Wolff-Parkinson-White syndrome	0.37% 1/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Eye disorders Papilloedema	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Gastrointestinal disorders Crohn's disease	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Gastrointestinal disorders Diarrhoea	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Gastrointestinal disorders Food poisoning	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Gastrointestinal disorders Gastric ulcer	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Gastrointestinal disorders Pancreatitis	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.74% 2/270 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Gastrointestinal disorders Umbilical hernia	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
General disorders Adverse drug reaction	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
General disorders Chest pain	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	1.5% 4/270 • Number of events 5 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
General disorders Death	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
General disorders Drug withdrawal syndrome	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
General disorders Oedema peripheral	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Hepatobiliary disorders Cholecystitis	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Hepatobiliary disorders Cirrhosis alcoholic	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Appendicitis	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Diverticulitis	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Escherichia infection	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Gastroenteritis	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Influenza	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.74% 2/270 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Kidney infection	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Periorbital cellulitis	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Post procedural infection	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Postoperative wound infection	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Alcohol poisoning	0.74% 2/271 • Number of events 7 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	1.1% 3/270 • Number of events 3 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Chemical injury	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Contrast media reaction	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Deep vein thrombosis postoperative	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Fall	0.74% 2/271 • Number of events 3 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Fibula fracture	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Intervertebral disc injury	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Post procedural complication	0.74% 2/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Road traffic accident	0.74% 2/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Metabolism and nutrition disorders Dehydration	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.74% 2/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Metabolism and nutrition disorders Hyperglycaemia	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Metabolism and nutrition disorders Obesity	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Back pain	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Bursitis	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Chondropathy	0.37% 1/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Joint instability	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Nervous system disorders Benign intracranial hypertension	0.37% 1/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Nervous system disorders Generalised tonic-clonic seizure	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Nervous system disorders Headache	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Nervous system disorders Hemiplegic migraine	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Nervous system disorders Memory impairment	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Nervous system disorders Postictal paralysis	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Nervous system disorders Seizure	0.37% 1/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Nervous system disorders Serotonin syndrome	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Nervous system disorders Syncope	0.74% 2/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Alcohol abuse	0.37% 1/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Alcohol withdrawal syndrome	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Anxiety	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.74% 2/270 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Completed suicide	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Dependence	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Depression	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Drug abuse	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	1.1% 3/270 • Number of events 3 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Hallucination, auditory	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Homicidal ideation	1.8% 5/271 • Number of events 9 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	1.1% 3/270 • Number of events 3 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Major depression	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.74% 2/270 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Panic attack	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Paranoia	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Post-traumatic stress disorder	0.74% 2/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.74% 2/270 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Psychotic behaviour	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Psychotic disorder	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Substance abuse	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.74% 2/270 • Number of events 3 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Suicidal behaviour	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Suicidal ideation	6.3% 17/271 • Number of events 29 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	6.3% 17/270 • Number of events 19 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Suicide attempt	1.5% 4/271 • Number of events 5 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	1.9% 5/270 • Number of events 6 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Reproductive system and breast disorders Priapism	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Respiratory, thoracic and mediastinal disorders Asthma	0.74% 2/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Social circumstances Alcohol use	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Social circumstances Physical assault	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Social circumstances Victim of crime	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Social circumstances Victim of homicide	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Surgical and medical procedures Alcohol detoxification	1.1% 3/271 • Number of events 6 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Surgical and medical procedures Detoxification	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Surgical and medical procedures Drug detoxification	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Surgical and medical procedures Elective surgery	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Surgical and medical procedures Knee arthroplasty	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Surgical and medical procedures Self-medication	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Surgical and medical procedures Spinal operation	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Vascular disorders Deep vein thrombosis	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Vascular disorders Hypertension	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	1.1% 3/270 • Number of events 4 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Vascular disorders Hypotension	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Vascular disorders Orthostatic hypotension	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.

Other adverse events

Measure	Individual Placement and Support (IPS) n=271 participants at risk Individual Placement \& Support: IPS uses an integrated "place-train" approach to help people obtain and maintain community-based competitive employment in their chosen occupation.	VA Transitional Work Program (TWP) n=270 participants at risk VA Transitional Work Program: The long-standing approach to vocational rehabilitation in VHA and state programs is the "train-place" or "stepwise" model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Cardiac disorders Bradycardia	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Cardiac disorders Cardiac disorder	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Eye disorders Ocular hyperaemia	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Eye disorders Visual impairment	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Gastrointestinal disorders Abdominal pain	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Gastrointestinal disorders Diarrhoea	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Gastrointestinal disorders Haematochezia	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Gastrointestinal disorders Haemorrhoids	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Gastrointestinal disorders Nausea	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Gastrointestinal disorders Toothache	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
General disorders Chest pain	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
General disorders Pyrexia	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Hepatobiliary disorders Cholelithiasis	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Hepatobiliary disorders Cirrhosis alcoholic	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Cellulitis	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Gastroenteritis	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	1.1% 3/270 • Number of events 3 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Upper respiratory tract infection	1.1% 3/271 • Number of events 3 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Urinary tract infection	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Infections and infestations Viral infection	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.74% 2/270 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Back injury	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.74% 2/270 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Chemical eye injury	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Concussion	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Exposure to violent event	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Fall	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Foreign body in eye	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Hand fracture	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Head injury	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Joint injury	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	1.1% 3/270 • Number of events 4 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Laceration	0.74% 2/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Ligament sprain	1.1% 3/271 • Number of events 3 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.74% 2/270 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Limb injury	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Muscle strain	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Procedural pain	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Rib fracture	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Scratch	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Metabolism and nutrition disorders Dehydration	0.74% 2/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Arthralgia	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Back pain	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.74% 2/270 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Costochondritis	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Exostosis	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Pain in extremity	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	1.9% 5/270 • Number of events 5 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Musculoskeletal and connective tissue disorders Tendonitis	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Nervous system disorders Dizziness	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Nervous system disorders Headache	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Aggression	0.74% 2/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.74% 2/270 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Alcohol abuse	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Anger	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Anxiety	1.5% 4/271 • Number of events 5 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Dependence	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Depression	0.74% 2/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Drug abuse	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Flashback	0.74% 2/271 • Number of events 3 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Insomnia	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Nightmare	0.74% 2/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Panic attack	0.37% 1/271 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Post-traumatic stress disorder	1.1% 3/271 • Number of events 3 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	1.1% 3/270 • Number of events 3 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Psychotic disorder	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Self-injurious ideation	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Substance abuse	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Suicidal behaviour	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Suicidal ideation	4.1% 11/271 • Number of events 13 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	1.9% 5/270 • Number of events 7 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Psychiatric disorders Violence-related symptom	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Renal and urinary disorders Dysuria	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Renal and urinary disorders Nephrolithiasis	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Reproductive system and breast disorders Breast mass	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Skin and subcutaneous tissue disorders Hair disorder	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Skin and subcutaneous tissue disorders Rash	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Social circumstances Alcohol use	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Social circumstances Loss of employment	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Social circumstances Stress at work	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Social circumstances Verbal abuse	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Social circumstances Victim of abuse	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 2 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Social circumstances Victim of sexual abuse	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Surgical and medical procedures Alcohol detoxification	0.37% 1/271 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.00% 0/270 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.
Vascular disorders Orthostatic hypotension	0.00% 0/271 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.	0.37% 1/270 • Number of events 1 • Adverse event data were collected for a period of 18 months for each participant. Active monitoring of adverse events was initiated as soon as the study participant was randomized and continued to 30 days post-study follow-up.

Additional Information

Tassos C. Kyriakides, Ph.D, Biostatistician

VA Cooperative Studies Program

Phone: 203-932-5711

Email: tassos.kyriakides@va.gov

Results disclosure agreements

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