Trial Outcomes & Findings for Implementing and Evaluating a Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic (NCT NCT04931888)
NCT ID: NCT04931888
Last Updated: 2023-11-30
Results Overview
Subscale from Trait Meta Mood Scale: Attention to Feelings Score, Maximum 35 (7 questions on a 1-5 Likert scale, with 35 being the highest score and 7 being the lowest score)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Baseline to 4 Weeks
Results posted on
2023-11-30
Participant Flow
Unit of analysis: Family
Participant milestones
| Measure |
Intervention - Child
The child respondents for the intervention group.
The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Intervention - Parent
The parent respondents for the intervention group.
The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Waitlist - Child
The child respondents for the waitlist group.
The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Waitlist - Parent
The parent respondents for the waitlist group.
The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17 5
|
5 0
|
6 3
|
3 0
|
|
Overall Study
COMPLETED
|
13 3
|
3 0
|
6 3
|
3 0
|
|
Overall Study
NOT COMPLETED
|
4 2
|
2 0
|
0 0
|
0 0
|
Reasons for withdrawal
| Measure |
Intervention - Child
The child respondents for the intervention group.
The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Intervention - Parent
The parent respondents for the intervention group.
The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Waitlist - Child
The child respondents for the waitlist group.
The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Waitlist - Parent
The parent respondents for the waitlist group.
The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
|---|---|---|---|---|
|
Overall Study
Excluded families participated in EMPOWER previously
|
4
|
2
|
0
|
0
|
Baseline Characteristics
Young children unable to answer questions were excluded
Baseline characteristics by cohort
| Measure |
Intervention - Child
n=13 Participants
The Child respondents for the intervention group.
The intervention arm will receive the EMPOWER curriculum between the pre- and post-evaluations.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Intervention - Parent
n=3 Participants
The Parent respondents for the intervention group.
The intervention arm will receive the EMPOWER curriculum between the pre- and post-evaluations.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Waitlist - Child
n=6 Participants
The Child respondents for the intervention group.
The waitlist control arm will receive the EMPOWER curriculum after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Waitlist - Parents
n=3 Participants
The Parent respondents for the intervention group.
The waitlist control arm will receive the EMPOWER curriculum after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
9.69 years
STANDARD_DEVIATION 0.76 • n=13 Participants
|
37.67 years
STANDARD_DEVIATION 2.33 • n=3 Participants
|
14.33 years
STANDARD_DEVIATION 3.51 • n=6 Participants
|
7.50 years
STANDARD_DEVIATION 0.85 • n=3 Participants
|
28.0 years
STANDARD_DEVIATION 2.0 • n=25 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=13 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
14 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=13 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
11 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
Afghan (Asian)
|
13 Participants
n=13 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
25 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=13 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
25 Participants
n=25 Participants
|
|
Primary Language
Pashto
|
9 Participants
n=13 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
17 Participants
n=25 Participants
|
|
Primary Language
Dari
|
4 Participants
n=13 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
8 Participants
n=25 Participants
|
|
Covid Knowledge Score
|
3.60 units on a scale
STANDARD_DEVIATION 0.22 • n=13 Participants • Young children unable to answer questions were excluded
|
4.33 units on a scale
STANDARD_DEVIATION 0.33 • n=3 Participants • Young children unable to answer questions were excluded
|
3.0 units on a scale
STANDARD_DEVIATION 1.0 • n=3 Participants • Young children unable to answer questions were excluded
|
3.33 units on a scale
STANDARD_DEVIATION 1.20 • n=3 Participants • Young children unable to answer questions were excluded
|
3.58 units on a scale
STANDARD_DEVIATION 0.26 • n=22 Participants • Young children unable to answer questions were excluded
|
|
Trait Meta Mood Scale
|
25.67 units on a scale
STANDARD_DEVIATION 1.43 • n=6 Participants • Participants who were parents were excluded, as responses reflected children's scores. Some responses were proxy responses (parent completed on behalf of child) and some were by children. If a parent expressed the child was too young to answer or have displayed answers to these questions, they did not complete the questions.
|
—
|
25 units on a scale
STANDARD_DEVIATION 2 • n=1 Participants • Participants who were parents were excluded, as responses reflected children's scores. Some responses were proxy responses (parent completed on behalf of child) and some were by children. If a parent expressed the child was too young to answer or have displayed answers to these questions, they did not complete the questions.
|
—
|
25.57 units on a scale
STANDARD_DEVIATION 1.23 • n=7 Participants • Participants who were parents were excluded, as responses reflected children's scores. Some responses were proxy responses (parent completed on behalf of child) and some were by children. If a parent expressed the child was too young to answer or have displayed answers to these questions, they did not complete the questions.
|
|
Pediatric Quality of Life Score
|
70 units on a scale
STANDARD_DEVIATION 4.57 • n=13 Participants • Responses are only for child respondents, some with proxy respondents and some with child respondents.
|
—
|
82.5 units on a scale
STANDARD_DEVIATION 4.87 • n=5 Participants • Responses are only for child respondents, some with proxy respondents and some with child respondents.
|
—
|
73.47 units on a scale
STANDARD_DEVIATION 3.75 • n=18 Participants • Responses are only for child respondents, some with proxy respondents and some with child respondents.
|
|
Parent Afghan Symptom Checklist Score
|
—
|
35.33 units on a scale
n=3 Participants • Only asked of parents. To save time and build trust, this exploratory measure was not asked on follow-up.
|
—
|
43 units on a scale
n=3 Participants • Only asked of parents. To save time and build trust, this exploratory measure was not asked on follow-up.
|
39.33 units on a scale
n=6 Participants • Only asked of parents. To save time and build trust, this exploratory measure was not asked on follow-up.
|
PRIMARY outcome
Timeframe: Baseline to 4 WeeksPopulation: Children were excluded if they or their parents were unsure how to answer. The question was only asked of and/or about child participants (not parents)
Subscale from Trait Meta Mood Scale: Attention to Feelings Score, Maximum 35 (7 questions on a 1-5 Likert scale, with 35 being the highest score and 7 being the lowest score)
Outcome measures
| Measure |
Intervention - Child
n=12 Participants
The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Intervention Parent
The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Waitlist - Child
n=2 Participants
The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Waitlist - Parent
The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
|---|---|---|---|---|
|
Change in Social Emotional Competence
|
25.33 units on a scale
Interval 20.83 to 29.83
|
—
|
20.00 units on a scale
Interval 13.52 to 26.48
|
—
|
PRIMARY outcome
Timeframe: Baseline to 4 WeeksPopulation: Young children unable to answer questions were excluded
Number Correct out of 5 (yes/no) COVID-19 Knowledge Questions. Score range 0-5, with 0 being the lowest score (incorrect for all questions), and 5 being the highest score (correct for all questions).
Outcome measures
| Measure |
Intervention - Child
n=10 Participants
The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Intervention Parent
n=3 Participants
The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Waitlist - Child
n=3 Participants
The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Waitlist - Parent
n=3 Participants
The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
|---|---|---|---|---|
|
Change in COVID-19 Knowledge
|
4.50 score on a scale
Interval 4.01 to 5.0
|
4.33 score on a scale
Interval 3.48 to 5.19
|
4.00 score on a scale
Interval 2.74 to 5.26
|
5 score on a scale
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline to 4 WeeksPopulation: Questions were only asked to or about children, not parents
Scored subscales of: emotional, social, and school functioning. Ten total questions, each scored on a 0-4 Likert scale. Scores transformed to a 0-100 scale, with higher scores indicating a higher quality of life score.
Outcome measures
| Measure |
Intervention - Child
n=13 Participants
The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Intervention Parent
The intervention arm received the EMPOWER curriculum between the pre- and post-evaluations.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Waitlist - Child
n=5 Participants
The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
Waitlist - Parent
The waitlist control arm received the EMPOWER curriculum and/or materials for EMPOWER after the evaluations. They will receive a second set of evaluations at the same time as the "post" evaluations of the control arm.
EMPOWER: EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
|
|---|---|---|---|---|
|
Change in Quality of Life
|
70 score on a scale
Interval 60.35 to 79.65
|
—
|
82.5 score on a scale
Interval 72.21 to 92.78
|
—
|
SECONDARY outcome
Timeframe: Only asked of parents. To save time and build trust, this exploratory measure was not asked on follow-up because of participant burden for questions.Population: Only asked of parents. To save time and build trust, this exploratory measure was not asked on follow-up because of participant burden for questions.
The Afhgan symptom checklist is a culturally-informed measure to evaluate distress and functioning in individuals from Afghanistan. We administered 21 of 22 questions to parents. Each question was scored on a scale of 1 to 5 (so minimum score (least distress) could be 21, and maximum score (most distressed) could be 105.
Outcome measures
Outcome data not reported
Adverse Events
Intervention - Child
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention - Parent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist - Child
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist - Parent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place