A Phase 2 interventional study of 98% pure CBD in ASD and Autism Spectrum Disorder, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by NYU Langone Health · Phase 2, Interventional, and Treatment
This is a 6-week open trial to identify the optimal dosing of cannabidiol (CBD) in youth with autism spectrum disorder (ASD) and to identify primary and secondary outcomes for future controlled studies. This study evaluates change in symptoms commonly associated with ASD, as evidence suggests that CBD may be effective in addressing difficulties such as irritability and anxiety, while maintaining a benign adverse effect (AE) profile in children and adolescents.
30 male and female participants with ASD between the ages of 7 and 17 years old are being recruited. Participants have fluent speech and an estimated IQ greater than or equal to 80. Study intervention is 98% pure CBD. The CBD is Greenwich Biosciences, Inc.'s 100mg/mL oral solution, brand name EPIDIOLEX. First, a Bayesian optimal interval (BOIN) design was used, such that participants were assigned to cohorts of size 3 receiving doses of 3, 6, or 9 mg/kg/day, depending on the treatment response of participants in prior cohorts.
The BOIN design ended after the fifth cohort of participants, and the two lower doses, 3 and 6 mg/kg/day, were eliminated. The highest dose, 9 mg/kg/day, was not tested. Therefore, in subsequent cohorts, we will be examining 9 mg/kg/day exclusively in up to 15 additional participants with co-occurring ASD and attention-deficit/hyperactivity disorder (ADHD) diagnoses, as this clinical profile appears to most closely resemble youth classified as responders within the BOIN design.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 29 is below the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
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Exclusion Criteria:
98% pure CBD. The CBD will be 100mg/mL oral solution provided by Greenwich Biosciences, Inc.
Drug: 98% pure CBD
A Bayesian optimal interval (BOIN) design was used, such that participants were assigned to cohorts of size 3 receiving doses of 3, 6, or 9 mg/kg/day, depending on the treatment response of participants in prior cohorts. The BOIN design has ended, and two doses have been tested and eliminated (3 and 6 mg/kg/day). We are now examining 9 mg/kg/day exclusively.
Clinical Global Impression Scale-Improvement (CGI-I)
The physician-rated CGI-I comprises one question asking how much a participant's condition has changed since baseline. The item is answered using a 7-point Likert scale, where 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse. The total score is the item response; lower scores indicate greater improvement.
Time frame: Week 6
Change in Repetitive Behavior Scale-Revised (RBS-R) Score
The RBS-R is a 43-item self report used to measure the breadth of repetitive behavior in children. For each item, behaviors are rated on a 4-point scale: 0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem. On the last question, participants are asked to "lump together" all of the behaviors described in the questionnaire, and provide a rating for how much of a problem these repetitive behaviors are overall, on a scale from 1-100: 1-Not a problem at all, to 100-As bad as you can imagine. A decrease in scores indicates the repetitive behaviors became less of a problem overall. The total score is the sum of all items and ranges from 0 to 229.
Time frame: Baseline, Week 6
Change in Social Responsiveness Scale, 2nd Edition (SRS-2), School-Age Form Score
The SRS-2 is a 65-item questionnaire assessing Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behavior. Items are scored on a 4-point scale (ranging from 1=not true to 4=almost always true). The raw score is the sum of responses and is converted to a T-score; the final T-score has a mean of 50 points with a standard deviation of 10 points, where lower scores indicate greater social responsiveness: * Less than or equal to 59 = Low-to-no symptom impacts * Between 60-65 = Mild-to-moderate defcits in social interaction * Between 66-75 = Moderate defcit in social interaction * Greater than or equal to 76 = Severe
Time frame: Baseline, Week 6
Change in Aberrant Behavior Checklist (ABC) - Irritability Subscale Score
The ABC Irritability subscale comprises 15 items rated on a 4-point scale (ranging from 0=no problem at all to 3 = problem is severe in degree). The total score is the sum of responses and ranges from 0 to 45; higher scores indicate greater presences of irritability related behavior.
Time frame: Baseline, Week 6
Change in Screen for Child Anxiety Related Disorders (SCARED), Parent Version Score
The SCARED, Parent Version is a 41-item parent-report measure developed to measure child anxiety symptoms. Subscales include Somatic Symptoms/Panic Disorder, Generalized Anxiety Disorder, Separation Anxiety, Social Phobia, and School Phobia. Items are rated on a 3-point scale ranging from 0=not true or hardly ever true to 2=very true or often true. The total score is the sum of responses and ranges from 0 to 82; lower scores indicate lesser child anxiety symptoms.
Time frame: Baseline, Week 6
Change in Sleep Disturbance Scale for Children (SDSC) Score
The SDSC is a 26-item parent-completed assessment of their child's sleep-wake rhythm. The questionnaire measures Disorders of Initiating and Maintaining Sleep, Sleep Breathing Disorders, Disorders of Arousal, Sleep Wake Transition Disorders, Disorders of Excessive Somnolence, and Sleep Hyperhydrosis. Items are rated on 5-point scale where 1=never and 5=always (daily). The total score is the sum of responses and ranges from 26 to 130; lower scores indicate healthier sleep-wake rhythms.
Time frame: Baseline, Week 6
Change in Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Parent/Caregiver Form Score
Used to measure adaptive functioning across three core domains (Communication, Daily Living Skills, and Socialization), and two optional domains (Motor Skills and Maladaptive Behavior); items are rated on a 3-point scale (0=never; 1=sometimes; 2=usually or often). The core domains sum to a total Adaptive Behavior Composite. The range of possible composite scores ranges from 20-140, with a higher score indicating higher levels of adaptive functioning.
Time frame: Baseline, Week 6
Change in Clinical Global Impression-Severity (CGI-S) Score
1-item assessment of clinicians impression of severity of illness. Illness severity is rated on a 7-point scale ranging from 1=not at all to 7=among the most extremely ill.
Time frame: Baseline, Week 6
Change in Autism Family Experience Questionnaire (AFEQ) Score
Parent/Caregiver form used to measure impact of autism interventions on family experience and quality of life. Items are rated on a 5-point scale where 1=always and 5=never. The total score is the sum of responses and ranges from 48 - 240; lower scores indicate better outcomes.
Time frame: Baseline, Week 6
Change in Anxiety Scale for Children - Autism Spectrum Disorder - Parent Versions (ASC-ASD-P) Score
24-item Parent/Caregiver-completed form developed to detect symptoms of anxiety in youth with ASD. Items are rated on a 4-point scale (0=never and 3=always). The total score is the sum of responses and ranges from 0 to 72; lower scores indicate lesser symptoms of anxiety.
Time frame: Baseline, Week 6
Anxiety Scale for Children - Autism Spectrum Disorder (ASC-ASD-C) - Child Version
24-item Child-completed form developed to detect symptoms of anxiety in youth with ASD. Items are rated on a 4-point scale (0=never and 3=always). The total score is the sum of responses and ranges from 0 to 72; lower scores indicate lesser symptoms of anxiety.
Time frame: Baseline, Week 6
Change in Ohio State University (OSU) Autism Clinical Global Impressions: Severity
Reflects clinicians impression of severity of illness on a 7-point scale ranging from 1=not present to 7="classic" autism.
Time frame: Baseline, Week 6
OSU Autism Clinical Global Impressions: Improvement
Reflects clinicians impression of improvement on a 7-point scale ranging from 1=very much improved to 7=very much worse.
Time frame: Week 6
Change in Behavioral Inflexibility Scale (BIS) Score
38-item Parent/Caregiver-completed measure designed to assess rigid patterns of behavior commonly associated with ASD. Items are rated on a 6-point Likert scale where 0=Not at all a problem and 5=Very severe or extreme problem. The total score is the sum of responses and ranges from 0 to 228; higher scores indicate greater behavioral inflexibility.
Time frame: Baseline, Week 6
Change in Home Situations Questionnaire - Modified for ASD (HSQ-ASD) Score
24-item Parent/Caregiver-completed questionnaire measuring behavioral noncompliance in everyday settings over the past four weeks. Severity of non-compliance is rated on a 9-point Likert scale (where 1 = no interruption, and 9 = frequent/consistent interruption). The total score is the sum of responses and ranges from 24 to 216; higher scores indicate greater behavioral noncompliance.
Time frame: Baseline, Week 6
Change in Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior (SWAN) Score
SWAN is an 18-item Parent/Caregiver-completed measure designed to assess symptoms of ADHD in children and adolescents. Items are rated on a 7-point Likert scale, where Far Below Average = 3, Below Average = 2, Somewhat Below Average = 1, Average = 0, Somewhat Above Average = -1, Above Average = -2, and Far Above Average = -3. The total score is the sum of responses and ranges from -54 to 54; the lower the score, the higher the severity of ADHD symptoms.
Time frame: Baseline, Week 6
| Milestone | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Started | 6 | 9 | 8 |
| Participants started part 1: 3 mg/kg/day | 6 | 0 | 0 |
| Participants completed part 1: 3 mg/kg/day | 6 | 0 | 0 |
| Participants started part 1: 6 mg/kg/day | 0 | 9 | 0 |
| Participants completed part 1: 6 mg/kg/day | 0 | 9 | 0 |
| Participants started part 2: 9 mg/kg/day | 0 | 0 | 8 |
| Participants completed part 2: 9 mg/kg/day | 0 | 0 | 8 |
| Completed | 6 | 9 | 8 |
| Not completed | 0 | 0 | 0 |
The physician-rated CGI-I comprises one question asking how much a participant's condition has changed since baseline. The item is answered using a 7-point Likert scale, where 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse. The total score is the item response; lower scores indicate greater improvement.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Clinical Global Impression Scale-Improvement (CGI-I) | 3.17 ± 0.75 | 2.56 ± 0.88 | 2.25 ± 0.71 |
The RBS-R is a 43-item self report used to measure the breadth of repetitive behavior in children. For each item, behaviors are rated on a 4-point scale: 0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem. On the last question, participants are asked to "lump together" all of the behaviors described in the questionnaire, and provide a rating for how much of a problem these repetitive behaviors are overall, on a scale from 1-100: 1-Not a problem at all, to 100-As bad as you can imagine. A decrease in scores indicates the repetitive behaviors became less of a problem overall. The total score is the sum of all items and ranges from 0 to 229.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Change in Repetitive Behavior Scale-Revised (RBS-R) Score | -0.5 ± 9.52 | -6.67 ± 9.41 | -4.38 ± 8.26 |
The SRS-2 is a 65-item questionnaire assessing Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behavior. Items are scored on a 4-point scale (ranging from 1=not true to 4=almost always true). The raw score is the sum of responses and is converted to a T-score; the final T-score has a mean of 50 points with a standard deviation of 10 points, where lower scores indicate greater social responsiveness: * Less than or equal to 59 = Low-to-no symptom impacts * Between 60-65 = Mild-to-moderate defcits in social interaction * Between 66-75 = Moderate defcit in social interaction * Greater than or equal to 76 = Severe
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Change in Social Responsiveness Scale, 2nd Edition (SRS-2), School-Age Form Score | -6.17 ± 5 | -14 ± 12.55 | -17.4 ± 5.5 |
The ABC Irritability subscale comprises 15 items rated on a 4-point scale (ranging from 0=no problem at all to 3 = problem is severe in degree). The total score is the sum of responses and ranges from 0 to 45; higher scores indicate greater presences of irritability related behavior.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Change in Aberrant Behavior Checklist (ABC) - Irritability Subscale Score | -5.5 ± 5.4 | -5.89 ± 7.51 | -1.4 ± 3.1 |
The SCARED, Parent Version is a 41-item parent-report measure developed to measure child anxiety symptoms. Subscales include Somatic Symptoms/Panic Disorder, Generalized Anxiety Disorder, Separation Anxiety, Social Phobia, and School Phobia. Items are rated on a 3-point scale ranging from 0=not true or hardly ever true to 2=very true or often true. The total score is the sum of responses and ranges from 0 to 82; lower scores indicate lesser child anxiety symptoms.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Change in Screen for Child Anxiety Related Disorders (SCARED), Parent Version Score | -6.33 ± 13.7 | -16 ± 17.12 | -3.25 ± 12.6 |
The SDSC is a 26-item parent-completed assessment of their child's sleep-wake rhythm. The questionnaire measures Disorders of Initiating and Maintaining Sleep, Sleep Breathing Disorders, Disorders of Arousal, Sleep Wake Transition Disorders, Disorders of Excessive Somnolence, and Sleep Hyperhydrosis. Items are rated on 5-point scale where 1=never and 5=always (daily). The total score is the sum of responses and ranges from 26 to 130; lower scores indicate healthier sleep-wake rhythms.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Change in Sleep Disturbance Scale for Children (SDSC) Score | -7.5 ± 12.65 | -6.89 ± 5.44 | -0.13 ± 4.82 |
Used to measure adaptive functioning across three core domains (Communication, Daily Living Skills, and Socialization), and two optional domains (Motor Skills and Maladaptive Behavior); items are rated on a 3-point scale (0=never; 1=sometimes; 2=usually or often). The core domains sum to a total Adaptive Behavior Composite. The range of possible composite scores ranges from 20-140, with a higher score indicating higher levels of adaptive functioning.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Change in Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Parent/Caregiver Form Score | -0.5 ± 3.89 | 4.33 ± 5.72 | 8.88 ± 7.32 |
1-item assessment of clinicians impression of severity of illness. Illness severity is rated on a 7-point scale ranging from 1=not at all to 7=among the most extremely ill.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Change in Clinical Global Impression-Severity (CGI-S) Score | -0.5 ± 0.84 | -1 ± 0.87 | -0.5 ± 0.53 |
Parent/Caregiver form used to measure impact of autism interventions on family experience and quality of life. Items are rated on a 5-point scale where 1=always and 5=never. The total score is the sum of responses and ranges from 48 - 240; lower scores indicate better outcomes.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Change in Autism Family Experience Questionnaire (AFEQ) Score | -3.17 ± 14.5 | -14 ± 20.1 | -8.88 ± 8.37 |
24-item Parent/Caregiver-completed form developed to detect symptoms of anxiety in youth with ASD. Items are rated on a 4-point scale (0=never and 3=always). The total score is the sum of responses and ranges from 0 to 72; lower scores indicate lesser symptoms of anxiety.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Change in Anxiety Scale for Children - Autism Spectrum Disorder - Parent Versions (ASC-ASD-P) Score | -2.33 ± 4.76 | -6.56 ± 9.84 | -3.13 ± 6.15 |
24-item Child-completed form developed to detect symptoms of anxiety in youth with ASD. Items are rated on a 4-point scale (0=never and 3=always). The total score is the sum of responses and ranges from 0 to 72; lower scores indicate lesser symptoms of anxiety.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Anxiety Scale for Children - Autism Spectrum Disorder (ASC-ASD-C) - Child Version | -4 ± 6.81 | -4.78 ± 5.61 | -6.5 ± 11.2 |
Reflects clinicians impression of severity of illness on a 7-point scale ranging from 1=not present to 7="classic" autism.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Change in Ohio State University (OSU) Autism Clinical Global Impressions: Severity | 0 ± 0 | -0.22 ± 0.67 | -0.38 ± 0.52 |
Reflects clinicians impression of improvement on a 7-point scale ranging from 1=very much improved to 7=very much worse.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| OSU Autism Clinical Global Impressions: Improvement | 3.67 ± 0.82 | 2.78 ± 0.67 | 2.38 ± 0.52 |
38-item Parent/Caregiver-completed measure designed to assess rigid patterns of behavior commonly associated with ASD. Items are rated on a 6-point Likert scale where 0=Not at all a problem and 5=Very severe or extreme problem. The total score is the sum of responses and ranges from 0 to 228; higher scores indicate greater behavioral inflexibility.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Change in Behavioral Inflexibility Scale (BIS) Score | -13 ± 28.61 | -25.4 ± 40.54 | -9.75 ± 13.73 |
24-item Parent/Caregiver-completed questionnaire measuring behavioral noncompliance in everyday settings over the past four weeks. Severity of non-compliance is rated on a 9-point Likert scale (where 1 = no interruption, and 9 = frequent/consistent interruption). The total score is the sum of responses and ranges from 24 to 216; higher scores indicate greater behavioral noncompliance.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Change in Home Situations Questionnaire - Modified for ASD (HSQ-ASD) Score | -8.67 ± 40.51 | -23.67 ± 20.02 | -5.88 ± 6.73 |
SWAN is an 18-item Parent/Caregiver-completed measure designed to assess symptoms of ADHD in children and adolescents. Items are rated on a 7-point Likert scale, where Far Below Average = 3, Below Average = 2, Somewhat Below Average = 1, Average = 0, Somewhat Above Average = -1, Above Average = -2, and Far Above Average = -3. The total score is the sum of responses and ranges from -54 to 54; the lower the score, the higher the severity of ADHD symptoms.
| score on a scale | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Change in Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior (SWAN) Score | — | — | -2.71 ± 8.08 |
Collected over 6 weeks after participant received first dose.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 3 mg/kg 98% Pure CBD | — | 0/6 (0%) | 6/6 (100%) |
| 6 mg/kg 98% Pure CBD | — | 0/9 (0%) | 8/9 (88.9%) |
| 9 mg/kg 98% Pure CBD | — | 0/8 (0%) | 6/8 (75%) |
| Event | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD |
|---|---|---|---|
| Increased SalivationEndocrine disorders | 1/6 | 2/9 | 4/8 |
| Increased sleep durationPsychiatric disorders | 1/6 | 4/9 | 4/8 |
| Sleepiness/SedationPsychiatric disorders | 3/6 | 2/9 | 1/8 |
| Increased Dream ActivityPsychiatric disorders | 1/6 | 3/9 | 4/8 |
| AkathesiaNervous system disorders | 1/6 | 2/9 | 3/8 |
| AstheniaPsychiatric disorders | 2/6 | 2/9 | 0/8 |
| EmotionalityPsychiatric disorders | 0/6 | 3/9 | 0/8 |
| OppositionalityPsychiatric disorders | 2/6 | 0/9 | 0/8 |
| RashSkin and subcutaneous tissue disorders | 0/6 | 3/9 | 0/8 |
| Palpitations/TachycardiaCardiac disorders | 0/6 | 0/9 | 2/8 |
| Age, Continuous(years) | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD | Total |
|---|---|---|---|---|
| Mean | 10.32 ± 2.18 | 11.21 ± 2.56 | 12.16 ± 3.4 | 11.31 ± 2.77 |
| Sex: Female, Male(Participants) | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD | Total |
|---|---|---|---|---|
| Female | 0 | 1 | 0 | 1 |
| Male | 6 | 8 | 8 | 22 |
| Ethnicity (NIH/OMB)(Participants) | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 4 | 4 | 8 |
| Not Hispanic or Latino | 6 | 4 | 4 | 14 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 |
| White | 3 | 6 | 7 | 16 |
| More than one race | 1 | 0 | 1 | 2 |
| Unknown or Not Reported | 0 | 2 | 0 | 2 |
| Region of Enrollment(participants) | 3 mg/kg 98% Pure CBD | 6 mg/kg 98% Pure CBD | 9 mg/kg 98% Pure CBD | Total |
|---|---|---|---|---|
| United States | 6 | 9 | 8 | 23 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Icf
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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