Trial Outcomes & Findings for Interventions for Unemployed Hazardous Drinkers (NCT NCT02559609)
NCT ID: NCT02559609
Last Updated: 2024-04-23
Results Overview
Greatest number of consecutive breath tests submitted on-time (within 1 hour of prompt) and reading alcohol negative (BAL \< 0.02)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-04-23
Participant Flow
Participant milestones
| Measure |
Group A - Standard Job Activity Contracting and Alcohol Monitoring
Standard services plus job activity contracting and alcohol monitoring
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group B - Reinforcement for Negative Alcohol Samples
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group C - Reinforcement for Completing Job Activities
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
Group D - Reinforcement for Negative Alcohol Samples & Job Activities
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
65
|
58
|
67
|
|
Overall Study
COMPLETED
|
50
|
64
|
58
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interventions for Unemployed Hazardous Drinkers
Baseline characteristics by cohort
| Measure |
Group A - Standard Job Activity Contracting and Alcohol Monitoring
n=50 Participants
Standard services plus job activity contracting and alcohol monitoring
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group B - Reinforcement for Negative Alcohol Samples
n=65 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group C - Reinforcement for Completing Job Activities
n=58 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
Group D - Reinforcement for Negative Alcohol Samples & Job Activities
n=67 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
240 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
46.10 years
STANDARD_DEVIATION 9.77 • n=5 Participants
|
45.94 years
STANDARD_DEVIATION 11.34 • n=7 Participants
|
42.38 years
STANDARD_DEVIATION 10.89 • n=5 Participants
|
46.37 years
STANDARD_DEVIATION 10.06 • n=4 Participants
|
45.23 years
STANDARD_DEVIATION 10.63 • n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
211 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
65 participants
n=7 Participants
|
58 participants
n=5 Participants
|
67 participants
n=4 Participants
|
240 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: N=234 analyzed. n=6 with no data: n=1 Group B withdrawal; n=5 had no samples submitted (n=1 Group A, n=1 Group B, n=1 group D) or none submitted on-time (n=2 Group B).
Greatest number of consecutive breath tests submitted on-time (within 1 hour of prompt) and reading alcohol negative (BAL \< 0.02)
Outcome measures
| Measure |
Group A - Standard Job Activity Contracting and Alcohol Monitoring
n=49 Participants
Standard services plus job activity contracting and alcohol monitoring
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group B - Reinforcement for Negative Alcohol Samples
n=61 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group C - Reinforcement for Completing Job Activities
n=58 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
Group D - Reinforcement for Negative Alcohol Samples & Job Activities
n=66 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
|---|---|---|---|---|
|
Longest Duration of Alcohol Abstinence (Samples) (Physiological Measure)
|
6.0 number of alcohol negative breath tests
Interval 3.0 to 14.0
|
11.0 number of alcohol negative breath tests
Interval 5.0 to 26.0
|
7.0 number of alcohol negative breath tests
Interval 4.0 to 17.3
|
7.5 number of alcohol negative breath tests
Interval 5.0 to 18.3
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: N=234 analyzed. n=6 with no data: n=1 Group B withdrawal; n=5 had no samples submitted (n=1 Group A, n=1 Group B, n=1 group D) or none submitted on-time (n=2 Group B).
Of alcohol breath tests requested, the percentage submitted on-time (within 1-hour of prompt) and reading alcohol-negative (BAL \< .02)
Outcome measures
| Measure |
Group A - Standard Job Activity Contracting and Alcohol Monitoring
n=49 Participants
Standard services plus job activity contracting and alcohol monitoring
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group B - Reinforcement for Negative Alcohol Samples
n=61 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group C - Reinforcement for Completing Job Activities
n=58 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
Group D - Reinforcement for Negative Alcohol Samples & Job Activities
n=66 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
|---|---|---|---|---|
|
Percent Alcohol Negative Breath Tests
|
90.8 percentage of alcohol negative tests
Interval 48.9 to 100.0
|
98.1 percentage of alcohol negative tests
Interval 78.9 to 100.0
|
91.2 percentage of alcohol negative tests
Interval 66.6 to 100.0
|
97.1 percentage of alcohol negative tests
Interval 67.0 to 100.0
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: N=228, n=12 no score: n=1 Group B withdrawal; n=1 Group D on disability (no working allowed); no data for n= 2 Group A, n=4 Group B, n=1 Group C, n=3 Group D
The percentage of days of work for pay (in the formal or informal economy), with the number of days of data in the denominator (missing data considered missing)
Outcome measures
| Measure |
Group A - Standard Job Activity Contracting and Alcohol Monitoring
n=48 Participants
Standard services plus job activity contracting and alcohol monitoring
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group B - Reinforcement for Negative Alcohol Samples
n=60 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group C - Reinforcement for Completing Job Activities
n=57 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
Group D - Reinforcement for Negative Alcohol Samples & Job Activities
n=63 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
|---|---|---|---|---|
|
Percent of Days Worked for Pay (Missing Data Treated as Missing)
|
1.79 percentage of days work occurred
Interval 0.0 to 22.99
|
4.76 percentage of days work occurred
Interval 0.0 to 24.4
|
6.25 percentage of days work occurred
Interval 0.0 to 25.77
|
1.33 percentage of days work occurred
Interval 0.0 to 26.19
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: N=228 analyzed. n=12 no score: n=1 Group B withdrawal; n=1 Group D on disability (no working allowed); no data for n= 2 Group A, n=4 Group B, n=1 Group C, n=3 Group D
From study day 1, the number of days until first worked in the formal or informal economy during the 12-week intervention, censored at day 85.
Outcome measures
| Measure |
Group A - Standard Job Activity Contracting and Alcohol Monitoring
n=48 Participants
Standard services plus job activity contracting and alcohol monitoring
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group B - Reinforcement for Negative Alcohol Samples
n=60 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group C - Reinforcement for Completing Job Activities
n=57 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
Group D - Reinforcement for Negative Alcohol Samples & Job Activities
n=63 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
|---|---|---|---|---|
|
Time to First Worked
|
79.50 days
Interval 15.0 to 85.0
|
57.00 days
Interval 24.0 to 85.0
|
63.00 days
Interval 16.5 to 85.0
|
63.00 days
Interval 16.0 to 85.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: N=228 analyzed. n=12 no score: n=1 Group B withdrawal; n=1 Group D on disability (no working allowed); no data for n= 2 Group A, n=4 Group B, n=1 Group C, n=3 Group D
The percent of days worked for pay (in the formal or informal economy), with 84 days (intervention period duration; missing treated as not working) in the denominator
Outcome measures
| Measure |
Group A - Standard Job Activity Contracting and Alcohol Monitoring
n=48 Participants
Standard services plus job activity contracting and alcohol monitoring
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group B - Reinforcement for Negative Alcohol Samples
n=60 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group C - Reinforcement for Completing Job Activities
n=57 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
Group D - Reinforcement for Negative Alcohol Samples & Job Activities
n=63 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
|---|---|---|---|---|
|
Percent of Days Worked for Pay (84 Day Intervention Period in the Denominator)
|
1.19 percentage of days work occurred
Interval 0.0 to 18.15
|
4.17 percentage of days work occurred
Interval 0.0 to 22.02
|
4.76 percentage of days work occurred
Interval 0.0 to 23.81
|
1.19 percentage of days work occurred
Interval 0.0 to 22.62
|
SECONDARY outcome
Timeframe: 12 weeksGreatest number of consecutive days of submitting all breath tests requested on-time and reading alcohol negative
Outcome measures
| Measure |
Group A - Standard Job Activity Contracting and Alcohol Monitoring
n=49 Participants
Standard services plus job activity contracting and alcohol monitoring
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group B - Reinforcement for Negative Alcohol Samples
n=61 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group C - Reinforcement for Completing Job Activities
n=58 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
Group D - Reinforcement for Negative Alcohol Samples & Job Activities
n=66 Participants
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
|---|---|---|---|---|
|
Longest Duration of Alcohol Abstinence (Days) (Physiological Measure)
|
4.0 days
Interval 2.0 to 10.0
|
9.0 days
Interval 3.0 to 19.0
|
5.0 days
Interval 3.0 to 12.3
|
6.0 days
Interval 3.0 to 13.5
|
Adverse Events
Group A - Standard Job Activity Contracting and Alcohol Monitoring
Serious events: 6 serious events
Other events: 5 other events
Deaths: 0 deaths
Group B - Reinforcement for Negative Alcohol Samples
Serious events: 8 serious events
Other events: 5 other events
Deaths: 0 deaths
Group C - Reinforcement for Completing Job Activities
Serious events: 9 serious events
Other events: 1 other events
Deaths: 1 deaths
Group D - Reinforcement for Negative Alcohol Samples & Job Activities
Serious events: 9 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A - Standard Job Activity Contracting and Alcohol Monitoring
n=50 participants at risk
Standard services plus job activity contracting and alcohol monitoring
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group B - Reinforcement for Negative Alcohol Samples
n=65 participants at risk
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group C - Reinforcement for Completing Job Activities
n=58 participants at risk
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
Group D - Reinforcement for Negative Alcohol Samples & Job Activities
n=67 participants at risk
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
|---|---|---|---|---|
|
General disorders
Inpatient substance use treatment
|
6.0%
3/50 • Number of events 5 • 12 months
|
4.6%
3/65 • Number of events 3 • 12 months
|
8.6%
5/58 • Number of events 12 • 12 months
|
9.0%
6/67 • Number of events 7 • 12 months
|
|
Psychiatric disorders
Inpatient psychiatric treatment
|
2.0%
1/50 • Number of events 2 • 12 months
|
1.5%
1/65 • Number of events 2 • 12 months
|
3.4%
2/58 • Number of events 3 • 12 months
|
1.5%
1/67 • Number of events 1 • 12 months
|
|
General disorders
Inpatient medical treatment
|
4.0%
2/50 • Number of events 2 • 12 months
|
6.2%
4/65 • Number of events 8 • 12 months
|
6.9%
4/58 • Number of events 6 • 12 months
|
6.0%
4/67 • Number of events 5 • 12 months
|
Other adverse events
| Measure |
Group A - Standard Job Activity Contracting and Alcohol Monitoring
n=50 participants at risk
Standard services plus job activity contracting and alcohol monitoring
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group B - Reinforcement for Negative Alcohol Samples
n=65 participants at risk
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
|
Group C - Reinforcement for Completing Job Activities
n=58 participants at risk
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities
activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
Group D - Reinforcement for Negative Alcohol Samples & Job Activities
n=67 participants at risk
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities
contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided
contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
|
|---|---|---|---|---|
|
General disorders
Emergency Room Visit
|
10.0%
5/50 • Number of events 6 • 12 months
|
7.7%
5/65 • Number of events 7 • 12 months
|
1.7%
1/58 • Number of events 1 • 12 months
|
9.0%
6/67 • Number of events 8 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place