Trial Outcomes & Findings for Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV (NCT NCT05314088)
NCT ID: NCT05314088
Last Updated: 2026-09-04
Results Overview
Daily text messaging at baseline for 10 days and after the intervention for 10 days assessed use of resilience resources following stressors. Participants were texted twice daily to ask if they experienced a stressor (YES/NO) and if YES, then responded on a 5 pt Likert scale on their use of 7 resilience resources: hardiness, optimism, self-efficacy, locus of control, positive reframing, proactive coping, and social support. Scores are average scores for each resource. Higher scores reflect greater levels of the resource (e.g., hardiness), and range from 1-5.
COMPLETED
NA
82 participants
immediately following the 4 week intervention
2026-09-04
Participant Flow
Participants were recruited between 03/2023 and 05/2025 via our university HIV clinic by queries of electronic medical record (EMR) data yielding a list of patients meeting basic criteria that have consented to be contacted for future studies. Patients meeting basic eligibility criteria were called to gauge interest and if interested, completed a brief phone screen to determine final eligibility.
One hundred and six participants were screened as eligible, meaning they met all eligibility criteria and were scheduled for a baseline visit. Of these, 82 completed baseline and were randomized (i.e., they were enrolled). No significant events occurred after enrollment but prior to assignment to a group/randomization.
Participant milestones
| Measure |
RISE+ Resilience Intervention
Participants in the intervention group came to the lab for four two-hour weekly sessions in small groups of 3-4. The intervention includes psychoeducational videos and individual written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. The intervention was facilitated by a trained research assistant but as in the pilot study, they were minimally involved (i.e., only administering the videos and explaining the activities) to keep the private reflective nature of the program that participants liked. Upon completion of the program, participants were given handouts with summaries of the program material.
|
Stress Reduction Control
Control participants completed an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games and activities. As with the intervention group, participants in the control group came to the lab for four two-hour weekly sessions in small groups of 3-4. Facilitator involvement was the same as the intervention group (e.g., the research assistant explained computer activities and games but will otherwise did not interact with participants).
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
Completed Intervention and Immediate Post Test
|
32
|
35
|
|
Overall Study
COMPLETED
|
25
|
32
|
|
Overall Study
NOT COMPLETED
|
16
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV
Baseline characteristics by cohort
| Measure |
Stress Reduction Control
n=41 Participants
Control participants completed an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games and activities. As with the intervention group, participants in the control group came to the lab for four two-hour weekly sessions in small groups of 3-4. Facilitator involvement was the same as the intervention group (e.g., the research assistant explained computer activities and games but will otherwise did not interact with participants).
|
Total
n=82 Participants
Total of all reporting groups
|
RISE+ Resilience Intervention
n=41 Participants
Participants in the intervention group came to the lab for four two-hour weekly sessions in small groups of 3-4. The intervention includes psychoeducational videos and individual written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. The intervention was facilitated by a trained research assistant but as in the pilot study, they were minimally involved (i.e., only administering the videos and explaining the activities) to keep the private reflective nature of the program that participants liked. Upon completion of the program, participants were given handouts with summaries of the program material.
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|---|---|---|---|
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Age, Continuous
|
58.7 Years
STANDARD_DEVIATION 6.2 • n=23 Participants
|
57.2 Years
STANDARD_DEVIATION 6.7 • n=22 Participants
|
55.8 Years
STANDARD_DEVIATION 6.8 • n=23 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=23 Participants
|
32 Participants
n=22 Participants
|
15 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=23 Participants
|
50 Participants
n=22 Participants
|
26 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=23 Participants
|
63 Participants
n=22 Participants
|
31 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=23 Participants
|
17 Participants
n=22 Participants
|
8 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=23 Participants
|
2 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=23 Participants
|
82 Participants
n=22 Participants
|
41 Participants
n=23 Participants
|
|
Center for Epidemiologic Studies Depression Scale (CESD)
|
15.0 Units on a scale
STANDARD_DEVIATION 10 • n=23 Participants
|
14.1 Units on a scale
STANDARD_DEVIATION 9.1 • n=22 Participants
|
13.2 Units on a scale
STANDARD_DEVIATION 8.0 • n=23 Participants
|
|
Perceived Stress Scale
|
14.7 Unit on a scale
STANDARD_DEVIATION 8.0 • n=23 Participants
|
13.8 Unit on a scale
STANDARD_DEVIATION 7.3 • n=22 Participants
|
13.0 Unit on a scale
STANDARD_DEVIATION 8.5 • n=23 Participants
|
|
Connor Davidson Resilience Scale 10-item Scale (CDRS10)
|
30.2 Unit on a scale
STANDARD_DEVIATION 6.9 • n=23 Participants
|
29.7 Unit on a scale
STANDARD_DEVIATION 7.1 • n=22 Participants
|
29.2 Unit on a scale
STANDARD_DEVIATION 7.3 • n=23 Participants
|
|
Brief Cope Problem Focused
|
2.8 Units on a scale
STANDARD_DEVIATION 0.6 • n=23 Participants
|
2.8 Units on a scale
STANDARD_DEVIATION 0.7 • n=22 Participants
|
2.8 Units on a scale
STANDARD_DEVIATION 0.8 • n=23 Participants
|
|
Brief Cope Emotion Focused
|
2.5 Units on a scale
STANDARD_DEVIATION 0.6 • n=23 Participants
|
2.4 Units on a scale
STANDARD_DEVIATION 0.6 • n=22 Participants
|
2.4 Units on a scale
STANDARD_DEVIATION 0.5 • n=23 Participants
|
|
Brief Cope Avoidant
|
1.9 Units on a scale
STANDARD_DEVIATION 0.5 • n=23 Participants
|
1.8 Units on a scale
STANDARD_DEVIATION 0.4 • n=22 Participants
|
1.7 Units on a scale
STANDARD_DEVIATION 0.4 • n=23 Participants
|
|
Personality in Intellectual Aging Contexts (PIC) Inventory Control Scale: Internal Locus of Control
|
7.7 Units on a scale
STANDARD_DEVIATION 1.9 • n=23 Participants
|
7.5 Units on a scale
STANDARD_DEVIATION 1.7 • n=22 Participants
|
7.4 Units on a scale
STANDARD_DEVIATION 1.4 • n=23 Participants
|
|
Duke Social Support Index (DSSI)
|
26.0 Units on a scale
STANDARD_DEVIATION 6.6 • n=23 Participants
|
27.2 Units on a scale
STANDARD_DEVIATION 6.7 • n=22 Participants
|
28.3 Units on a scale
STANDARD_DEVIATION 6.8 • n=23 Participants
|
|
HIV Treatment Adherence Self Efficacy Scale (ASES)
|
9.0 Units on a scale
STANDARD_DEVIATION 1.4 • n=23 Participants
|
8.8 Units on a scale
STANDARD_DEVIATION 1.4 • n=22 Participants
|
8.7 Units on a scale
STANDARD_DEVIATION 1.4 • n=23 Participants
|
|
The Revised HIV Stigma Scale (HSS-32)
|
33.7 Units on a scale
STANDARD_DEVIATION 7.9 • n=23 Participants
|
33.8 Units on a scale
STANDARD_DEVIATION 8.3 • n=22 Participants
|
33.8 Units on a scale
STANDARD_DEVIATION 8.7 • n=23 Participants
|
|
3-Item HIV Medication Adherence Scale
|
83.9 Units on a scale
STANDARD_DEVIATION 22.1 • n=23 Participants
|
85.1 Units on a scale
STANDARD_DEVIATION 19.8 • n=22 Participants
|
86.3 Units on a scale
STANDARD_DEVIATION 17.3 • n=23 Participants
|
|
HIV Visual Analog Scale (HIV-VAS)
|
91.0 Units on a scale
STANDARD_DEVIATION 18.8 • n=23 Participants
|
92.5 Units on a scale
STANDARD_DEVIATION 15.4 • n=22 Participants
|
93.9 Units on a scale
STANDARD_DEVIATION 11.1 • n=23 Participants
|
PRIMARY outcome
Timeframe: immediately following the 4 week interventionPopulation: Although 82 (41 per group) completed baseline and were randomized, only 67 (35 control/32 intervention) completed the 1 month assessment. Only 36 control completed baseline texting, and 34 completed 1 month texting. While 41 in the RISE group completed baseline texting, only 31 completed 1 month texting. Furthermore, for resilience resources, participants had to have at least one text messaging instance with a stressor, which explains the analyzed sample sizes.
Daily text messaging at baseline for 10 days and after the intervention for 10 days assessed use of resilience resources following stressors. Participants were texted twice daily to ask if they experienced a stressor (YES/NO) and if YES, then responded on a 5 pt Likert scale on their use of 7 resilience resources: hardiness, optimism, self-efficacy, locus of control, positive reframing, proactive coping, and social support. Scores are average scores for each resource. Higher scores reflect greater levels of the resource (e.g., hardiness), and range from 1-5.
Outcome measures
| Measure |
Stress Reduction Control
n=21 Participants
Control participants completed an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games and activities. As with the intervention group, participants in the control group came to the lab for four two-hour weekly sessions in small groups of 3-4. Facilitator involvement was the same as the intervention group (e.g., the research assistant explained computer activities and games but will otherwise did not interact with participants).
|
RISE+ Resilience Intervention
n=25 Participants
Participants in the intervention group came to the lab for four two-hour weekly sessions in small groups of 3-4. The intervention includes psychoeducational videos and individual written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. The intervention was facilitated by a trained research assistant but as in the pilot study, they were minimally involved (i.e., only administering the videos and explaining the activities) to keep the private reflective nature of the program that participants liked. Upon completion of the program, participants were given handouts with summaries of the program material.
|
|---|---|---|
|
Experience Sampling Method (ESM) Resilience Resources-Hardiness
baseline
|
2.53 Units on a scale
Standard Error 0.12
|
2.56 Units on a scale
Standard Error 0.12
|
|
Experience Sampling Method (ESM) Resilience Resources-Hardiness
1 month
|
2.63 Units on a scale
Standard Error 0.14
|
2.53 Units on a scale
Standard Error 0.13
|
PRIMARY outcome
Timeframe: immediately following the 4 week interventionPopulation: Although 82 (41 per group) completed baseline and were randomized, only 67 (35 control/32 intervention) completed the 1 month assessment. Only 36 control completed baseline texting, and 34 completed 1 month texting. While 41 in the RISE group completed baseline texting, only 31 completed 1 month texting. Furthermore, for stress reactivity, participants had to have at least one text messaging instance with a stressor and one without a stressor, which explains the analyzed sample sizes.
Participants were texted a survey link twice daily for 10 days at baseline and immediately following the intervention which asked if they experienced a stressor (YES/NO) and then they respond on a scale of 1-4 their positive and negative affect (10 items for positive affect and 10 for negative affect). The average difference in negative affect between stressor and non-stressor instances was calculated to reflect negative stress reactivity: Higher scores reflect on average a higher negative emotional state when a stressor is reported vs when a stressor is not reported; scores closer to zero reflect less impact of a stressor on negative affect; lower scores \[i.e., below zero\] reflect on average lower negative emotional state when a stressor is reported vs when a stressor is not reported. The possible range for the negative affect scale is 10-40, therefore the possible average range for the difference between 2 negative affect occasions is -30 to 30.
Outcome measures
| Measure |
Stress Reduction Control
n=18 Participants
Control participants completed an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games and activities. As with the intervention group, participants in the control group came to the lab for four two-hour weekly sessions in small groups of 3-4. Facilitator involvement was the same as the intervention group (e.g., the research assistant explained computer activities and games but will otherwise did not interact with participants).
|
RISE+ Resilience Intervention
n=23 Participants
Participants in the intervention group came to the lab for four two-hour weekly sessions in small groups of 3-4. The intervention includes psychoeducational videos and individual written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. The intervention was facilitated by a trained research assistant but as in the pilot study, they were minimally involved (i.e., only administering the videos and explaining the activities) to keep the private reflective nature of the program that participants liked. Upon completion of the program, participants were given handouts with summaries of the program material.
|
|---|---|---|
|
Experience Sampling Method (ESM) Negative Stress Reactivity
baseline
|
3.53 Units on a scale
Standard Error 0.61
|
3.18 Units on a scale
Standard Error 0.60
|
|
Experience Sampling Method (ESM) Negative Stress Reactivity
1 month
|
3.37 Units on a scale
Standard Error 0.92
|
3.17 Units on a scale
Standard Error 0.72
|
SECONDARY outcome
Timeframe: 1 month after interventionPopulation: Although 82 (41 per group) completed baseline and were randomized, only 67 (35 control/32 intervention) completed the 1 month assessment. Analyses with constrained longitudinal modeling included all randomized participants (41 control / 41 intervention). Follow-up outcome data were available for 35 control / 32 intervention, respectively. Maximum likelihood estimation used all available data from all 82 randomized participants.
The Medical Outcome Study (MOS) RAND 36-Item Short-Form Health Survey (RAND 36SF) is was used to assess Quality of Life (QOL). For the physical health related QOL composite, scores range from 0-100 with higher scores reflecting better QOL.
Outcome measures
| Measure |
Stress Reduction Control
n=41 Participants
Control participants completed an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games and activities. As with the intervention group, participants in the control group came to the lab for four two-hour weekly sessions in small groups of 3-4. Facilitator involvement was the same as the intervention group (e.g., the research assistant explained computer activities and games but will otherwise did not interact with participants).
|
RISE+ Resilience Intervention
n=41 Participants
Participants in the intervention group came to the lab for four two-hour weekly sessions in small groups of 3-4. The intervention includes psychoeducational videos and individual written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. The intervention was facilitated by a trained research assistant but as in the pilot study, they were minimally involved (i.e., only administering the videos and explaining the activities) to keep the private reflective nature of the program that participants liked. Upon completion of the program, participants were given handouts with summaries of the program material.
|
|---|---|---|
|
Medical Outcome Study RAND 36-Item Short-Form Health Survey (RAND 36SF)-Physical Health Related QOL Composite
baseline
|
60.5 Units on a scale
Standard Error 3.61
|
62.0 Units on a scale
Standard Error 3.83
|
|
Medical Outcome Study RAND 36-Item Short-Form Health Survey (RAND 36SF)-Physical Health Related QOL Composite
1 month
|
60.63 Units on a scale
Standard Error 3.28
|
62.35 Units on a scale
Standard Error 3.39
|
SECONDARY outcome
Timeframe: 1 month after the intervenionPopulation: Although 82 (41 per group) completed baseline and were randomized, only 67 (35 control/32 intervention) completed the 1 month assessment. Analyses with constrained longitudinal modeling included all randomized participants (41 control / 41 intervention). Follow-up outcome data were available for 35 control / 32 intervention, respectively. Maximum likelihood estimation used all available data from all 82 randomized participants.
Centers for Epidemiological Studies Depression Scale assesses depressive symptoms and higher scores reflect greater depressive symptoms. Scores range from 0-60, with higher score reflecting greater depressive symptoms and scores \>=16 reflect clinically relevant symptoms
Outcome measures
| Measure |
Stress Reduction Control
n=41 Participants
Control participants completed an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games and activities. As with the intervention group, participants in the control group came to the lab for four two-hour weekly sessions in small groups of 3-4. Facilitator involvement was the same as the intervention group (e.g., the research assistant explained computer activities and games but will otherwise did not interact with participants).
|
RISE+ Resilience Intervention
n=41 Participants
Participants in the intervention group came to the lab for four two-hour weekly sessions in small groups of 3-4. The intervention includes psychoeducational videos and individual written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. The intervention was facilitated by a trained research assistant but as in the pilot study, they were minimally involved (i.e., only administering the videos and explaining the activities) to keep the private reflective nature of the program that participants liked. Upon completion of the program, participants were given handouts with summaries of the program material.
|
|---|---|---|
|
Centers for Epidemiological Studies Depression Scale (CESD)
baseline
|
15.0 scores on a scale, >=16 is depression
Standard Error 1.57
|
13.2 scores on a scale, >=16 is depression
Standard Error 1.25
|
|
Centers for Epidemiological Studies Depression Scale (CESD)
1 month
|
15.1 scores on a scale, >=16 is depression
Standard Error 1.44
|
13.59 scores on a scale, >=16 is depression
Standard Error 1.49
|
SECONDARY outcome
Timeframe: 1 month after interventionPopulation: Although 82 (41 per group) completed baseline and were randomized, only 67 (35 control/32 intervention) completed the 1 month assessment. Analyses with constrained longitudinal modeling included all randomized participants (41 control / 41 intervention). Follow-up outcome data were available for 35 control / 32 intervention, respectively. Maximum likelihood estimation used all available data from all 82 randomized participants.
Visual Analogue Scale of HIV ART adherence, higher scores reflect better self reported adherence to HIV medication. Total scores are on a 0-100% scale with a higher score indicating better adherence.
Outcome measures
| Measure |
Stress Reduction Control
n=41 Participants
Control participants completed an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games and activities. As with the intervention group, participants in the control group came to the lab for four two-hour weekly sessions in small groups of 3-4. Facilitator involvement was the same as the intervention group (e.g., the research assistant explained computer activities and games but will otherwise did not interact with participants).
|
RISE+ Resilience Intervention
n=41 Participants
Participants in the intervention group came to the lab for four two-hour weekly sessions in small groups of 3-4. The intervention includes psychoeducational videos and individual written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. The intervention was facilitated by a trained research assistant but as in the pilot study, they were minimally involved (i.e., only administering the videos and explaining the activities) to keep the private reflective nature of the program that participants liked. Upon completion of the program, participants were given handouts with summaries of the program material.
|
|---|---|---|
|
HIV Medication Adherence Visual Analogue Scale (VAS)
baseline
|
91.0 Units on a scale
Standard Error 2.94
|
93.9 Units on a scale
Standard Error 1.74
|
|
HIV Medication Adherence Visual Analogue Scale (VAS)
1 month
|
89.98 Units on a scale
Standard Error 2.39
|
95.09 Units on a scale
Standard Error 2.49
|
SECONDARY outcome
Timeframe: 1 month after interventionPopulation: Although 82 (41 per group) completed baseline and were randomized, only 67 (35 control/32 intervention) completed the 1 month assessment. Analyses with constrained longitudinal modeling included all randomized participants (41 control / 41 intervention). Follow-up outcome data were available for 35 control / 32 intervention, respectively. Maximum likelihood estimation used all available data from all 82 randomized participants.
HIV Treatment Adherence Self-Efficacy Scale, higher scores reflect higher self efficacy for HIV treatment adherence. Total scores range from 0-10 with higher scores reflecting higher confidence in treatment management abilities.
Outcome measures
| Measure |
Stress Reduction Control
n=41 Participants
Control participants completed an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games and activities. As with the intervention group, participants in the control group came to the lab for four two-hour weekly sessions in small groups of 3-4. Facilitator involvement was the same as the intervention group (e.g., the research assistant explained computer activities and games but will otherwise did not interact with participants).
|
RISE+ Resilience Intervention
n=41 Participants
Participants in the intervention group came to the lab for four two-hour weekly sessions in small groups of 3-4. The intervention includes psychoeducational videos and individual written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. The intervention was facilitated by a trained research assistant but as in the pilot study, they were minimally involved (i.e., only administering the videos and explaining the activities) to keep the private reflective nature of the program that participants liked. Upon completion of the program, participants were given handouts with summaries of the program material.
|
|---|---|---|
|
HIV Treatment Adherence Self Efficacy Scale (ASES)
baseline
|
9.0 Units on a scale
Standard Error 0.22
|
8.7 Units on a scale
Standard Error 0.22
|
|
HIV Treatment Adherence Self Efficacy Scale (ASES)
1 month
|
8.9 Units on a scale
Standard Error 0.18
|
9.24 Units on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: 3 months after interventionPopulation: Note that the full 82 participants randomized have viral load data, because this was extracted from EMR, so even those who did not do the followup were included.
HIV plasma viral load (copies per mL of plasma) extracted from medical records; higher is worse HIV severity; reported in Log10. The clinical quantifiable range for an HIV viral load test typically spans from 1.3 to 7.0 Log10 copies/mL (representing actual raw values from 20 to 10,000,000 copies/mL).
Outcome measures
| Measure |
Stress Reduction Control
n=41 Participants
Control participants completed an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games and activities. As with the intervention group, participants in the control group came to the lab for four two-hour weekly sessions in small groups of 3-4. Facilitator involvement was the same as the intervention group (e.g., the research assistant explained computer activities and games but will otherwise did not interact with participants).
|
RISE+ Resilience Intervention
n=41 Participants
Participants in the intervention group came to the lab for four two-hour weekly sessions in small groups of 3-4. The intervention includes psychoeducational videos and individual written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. The intervention was facilitated by a trained research assistant but as in the pilot study, they were minimally involved (i.e., only administering the videos and explaining the activities) to keep the private reflective nature of the program that participants liked. Upon completion of the program, participants were given handouts with summaries of the program material.
|
|---|---|---|
|
HIV Viral Load
baseline
|
1.87 HIVRNA copies per/mL of plasma in Log10
Standard Error 0.15
|
1.97 HIVRNA copies per/mL of plasma in Log10
Standard Error 0.18
|
|
HIV Viral Load
3 months
|
1.93 HIVRNA copies per/mL of plasma in Log10
Standard Error 0.18
|
1.77 HIVRNA copies per/mL of plasma in Log10
Standard Error 0.19
|
Adverse Events
RISE+ Resilience Intervention
Stress Reduction Control
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