Trial Outcomes & Findings for Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians (NCT NCT03687450)
NCT ID: NCT03687450
Last Updated: 2020-07-23
Results Overview
Participants were ask to rate the feasibility of attending the yoga program on a visual analogue scale from 0 (not at all feasible) to 100 (very feasible). Only the intervention group rated feasibility since the control group was a waitlist control group and did not attend the program. The standard deviation of the mean score was calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
Post-program
Results posted on
2020-07-23
Participant Flow
Participant milestones
| Measure |
Intervention (Yoga) Arm
This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
|
No-treatment Control Arm
This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
18
|
|
Overall Study
Post-Program Follow-Up
|
28
|
15
|
|
Overall Study
Two-month Follow-up
|
26
|
16
|
|
Overall Study
COMPLETED
|
26
|
16
|
|
Overall Study
NOT COMPLETED
|
12
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians
Baseline characteristics by cohort
| Measure |
Intervention (Yoga) Arm
n=28 Participants
This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
|
No-treatment Control Arm
n=16 Participants
This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.3 years
n=5 Participants
|
29.1 years
n=7 Participants
|
29.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Year in Training
1st year
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Year in Training
2nd year
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Year in Training
3rd year
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Year in Training
4th year and above
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Specialty
Internal Medicine
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Specialty
OB/GYN
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Specialty
Diagnostic Radiology
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Specialty
Emergency Medicine
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Specialty
Psychiatry
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Specialty
Medicine-Pediatrics
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Specialty
Anesthesiology
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Specialty
Physical Medicine & Rehabilitation
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-programPopulation: Participants analyzed included those in the intervention group who completed any follow-up timepoint, including post-program and/or two-month follow-up. Since the waitlist control group did not attend the program, they were not asked to assess feasibility.
Participants were ask to rate the feasibility of attending the yoga program on a visual analogue scale from 0 (not at all feasible) to 100 (very feasible). Only the intervention group rated feasibility since the control group was a waitlist control group and did not attend the program. The standard deviation of the mean score was calculated.
Outcome measures
| Measure |
Intervention (Yoga) Arm
n=28 Participants
This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
|
No-treatment Control Arm
This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
|
|---|---|---|
|
Feasibility of Attending the Yoga Program
|
28.9 visual analogue scale, 0 to 100
Standard Deviation 25.6
|
—
|
SECONDARY outcome
Timeframe: Post-program and 2-month follow-upMaslach Burnout Inventory (short form, 2 items) - scores from 0-12; higher is more burnout
Outcome measures
| Measure |
Intervention (Yoga) Arm
n=28 Participants
This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
|
No-treatment Control Arm
n=16 Participants
This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
|
|---|---|---|
|
Difference in Burnout
Baseline
|
6.23 score on a scale
Standard Error 0.52
|
6.33 score on a scale
Standard Error 0.92
|
|
Difference in Burnout
Post-program
|
5.65 score on a scale
Standard Error 0.50
|
6.83 score on a scale
Standard Error 0.66
|
|
Difference in Burnout
2-month follow-up
|
5.72 score on a scale
Standard Error 0.53
|
6.43 score on a scale
Standard Error 0.99
|
SECONDARY outcome
Timeframe: Baseline, post-program, and 2-month follow-upProfessional Fulfillment Index (PFI; 16 items) - scores from 0-4 for professional fulfillment scale; higher is more fulfillment
Outcome measures
| Measure |
Intervention (Yoga) Arm
n=28 Participants
This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
|
No-treatment Control Arm
n=16 Participants
This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
|
|---|---|---|
|
Difference in Professional Fulfillment
Baseline
|
1.70 score on a scale
Standard Error 0.12
|
1.53 score on a scale
Standard Error 0.18
|
|
Difference in Professional Fulfillment
Post-program
|
1.35 score on a scale
Standard Error 0.14
|
1.48 score on a scale
Standard Error 0.20
|
|
Difference in Professional Fulfillment
2-month follow-up
|
1.38 score on a scale
Standard Error 0.10
|
1.56 score on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline, post-program, and 2-month follow-upResident Well-Being Index (7 items) - scores from 0-7; higher is worse wellbeing
Outcome measures
| Measure |
Intervention (Yoga) Arm
n=28 Participants
This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
|
No-treatment Control Arm
n=16 Participants
This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
|
|---|---|---|
|
Difference in Resident Well-being
Baseline
|
4.19 score on a scale
Standard Error 0.30
|
4.08 score on a scale
Standard Error 0.58
|
|
Difference in Resident Well-being
Post-program
|
3.15 score on a scale
Standard Error 0.33
|
3.62 score on a scale
Standard Error 0.35
|
|
Difference in Resident Well-being
2-month follow-up
|
3.40 score on a scale
Standard Error 0.37
|
3.25 score on a scale
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Baseline, post-program, and 2-month follow-upResilience Scale (RS-14; 14 items) - scores from 14-98; higher more resilience
Outcome measures
| Measure |
Intervention (Yoga) Arm
n=28 Participants
This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
|
No-treatment Control Arm
n=15 Participants
This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
|
|---|---|---|
|
Difference in Resilience
Baseline
|
70.61 score on a scale
Standard Error 2.26
|
71.20 score on a scale
Standard Error 3.14
|
|
Difference in Resilience
Post-program
|
76.32 score on a scale
Standard Error 1.79
|
72.07 score on a scale
Standard Error 3.02
|
|
Difference in Resilience
2-month follow-up
|
72.61 score on a scale
Standard Error 1.76
|
72.43 score on a scale
Standard Error 3.22
|
SECONDARY outcome
Timeframe: Baseline, post-program, and 2-month follow-upFive Facet Mindfulness Questionnaire (FFMQ; short form, 15 items) - scores from 15-75; higher score means more mindfulness
Outcome measures
| Measure |
Intervention (Yoga) Arm
n=28 Participants
This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
|
No-treatment Control Arm
n=16 Participants
This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
|
|---|---|---|
|
Difference in Mindfulness
Baseline
|
48.54 score on a scale
Standard Error 1.14
|
48.60 score on a scale
Standard Error 1.92
|
|
Difference in Mindfulness
Post-program
|
54.27 score on a scale
Standard Error 1.42
|
49.73 score on a scale
Standard Error 1.54
|
|
Difference in Mindfulness
2-month follow-up
|
51.83 score on a scale
Standard Error 0.99
|
48.56 score on a scale
Standard Error 1.49
|
SECONDARY outcome
Timeframe: Baseline, post-program, and 2-month follow-upPerceived Stress Scale (PSS; 10 items) - scores from 0-40; higher is more stress
Outcome measures
| Measure |
Intervention (Yoga) Arm
n=28 Participants
This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
|
No-treatment Control Arm
n=16 Participants
This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
|
|---|---|---|
|
Difference in Stress
Baseline
|
19.74 score on a scale
Standard Error 1.09
|
20.69 score on a scale
Standard Error 1.88
|
|
Difference in Stress
Post-program
|
16.15 score on a scale
Standard Error 1.38
|
18.23 score on a scale
Standard Error 1.36
|
|
Difference in Stress
2-month follow-up
|
16.52 score on a scale
Standard Error 0.85
|
18.88 score on a scale
Standard Error 1.90
|
SECONDARY outcome
Timeframe: Baseline, post-program, and 2-month follow-upPatient Reported Outcomes Measurement Information System (PROMIS) Depression (short form: depression-4) - scores from 4-20, higher is more depression
Outcome measures
| Measure |
Intervention (Yoga) Arm
n=28 Participants
This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
|
No-treatment Control Arm
n=16 Participants
This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
|
|---|---|---|
|
Difference in Depression
Baseline
|
7.56 score on a scale
Standard Error 0.64
|
7.15 score on a scale
Standard Error 1.13
|
|
Difference in Depression
Post-program
|
6.48 score on a scale
Standard Error 0.54
|
7.23 score on a scale
Standard Error 0.75
|
|
Difference in Depression
2-month follow-up
|
7.24 score on a scale
Standard Error 0.61
|
7.81 score on a scale
Standard Error 0.94
|
SECONDARY outcome
Timeframe: Baseline, post-program, and 2-month follow-upPROMIS Sleep Disturbance (short form, 4 items) - scores from 4-20, higher is more sleep disturbance
Outcome measures
| Measure |
Intervention (Yoga) Arm
n=28 Participants
This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
|
No-treatment Control Arm
n=16 Participants
This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
|
|---|---|---|
|
Difference in Sleep Quality
Baseline
|
10.38 score on a scale
Standard Error 0.62
|
11.62 score on a scale
Standard Error 1.28
|
|
Difference in Sleep Quality
Post-program
|
8.73 score on a scale
Standard Error 0.59
|
9.92 score on a scale
Standard Error 0.91
|
|
Difference in Sleep Quality
2-month follow-up
|
8.96 score on a scale
Standard Error 0.61
|
8.50 score on a scale
Standard Error 1.02
|
SECONDARY outcome
Timeframe: Baseline, post-program, and 2-month follow-upPatient Reported Outcomes Measurement Information System (PROMIS) Anxiety (short form: anxiety-4) - scores from 4-20, higher is more anxiety
Outcome measures
| Measure |
Intervention (Yoga) Arm
n=28 Participants
This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
|
No-treatment Control Arm
n=16 Participants
This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
|
|---|---|---|
|
Difference in Anxiety
Baseline
|
9.65 score on a scale
Standard Error 0.60
|
10.00 score on a scale
Standard Error 1.00
|
|
Difference in Anxiety
Post-program
|
8.54 score on a scale
Standard Error 0.59
|
9.15 score on a scale
Standard Error 0.94
|
|
Difference in Anxiety
2-month follow-up
|
8.96 score on a scale
Standard Error 0.57
|
7.94 score on a scale
Standard Error 0.81
|
SECONDARY outcome
Timeframe: Baseline, post-program, and 2-month follow-upProfessional Fulfillment Index (PFI; 16 items) - scores from 0-4 for the burnout scale; higher is more burnout
Outcome measures
| Measure |
Intervention (Yoga) Arm
n=28 Participants
This is the group that will receive a weekly 60-90minute yoga-based class for six weeks and direction for a 5-10 minute daily home practice.
RISE yoga-based program: The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga \& Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
|
No-treatment Control Arm
n=16 Participants
This group will receive no intervention during the study. At the conclusion of the study, this group will receive one free yoga-based class.
|
|---|---|---|
|
Differences in Professional Fulfillment - Burnout Sub-Item
Post-program
|
2.47 score on a scale
Standard Error 0.15
|
2.13 score on a scale
Standard Error 0.19
|
|
Differences in Professional Fulfillment - Burnout Sub-Item
2-month follow-up
|
2.31 score on a scale
Standard Error 0.11
|
2.02 score on a scale
Standard Error 0.22
|
|
Differences in Professional Fulfillment - Burnout Sub-Item
Baseline
|
2.26 score on a scale
Standard Error 0.13
|
1.97 score on a scale
Standard Error 0.23
|
Adverse Events
Intervention (Yoga) Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No-treatment Control Arm
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