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Although cognitive-behavioral therapy (CBT) has shown efficacy in reducing symptoms and rates of mood relapse in adolescents at high risk for severe mood disorders (SMD; i.e., bipolar I/II disorder and recurrent or unremitting major depression), a significant limitation to the CBT's efficacy is the low rate of participant adherence to the prescribed between-session homework tasks. Mobile health applications have the potential to improve adherence to and acceptance of treatment through embedded treatment content, skill-practice, thought and symptom monitoring, all of which are facilitated by reward contingencies and notifications. This study examines whether a mobile application-enhanced CBT can improve participant adherence and treatment acceptance for adolescents at high risk for SMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive behavioral therapy (CBT)_no app | Active Comparator |
| |
| Cognitive behavioral therapy (CBT) with mobile app | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy (CBT) | Behavioral | Group-based transdiagnostic cognitive-behavioral treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Skill Practice | Sum of all treatment skill practices completed through the course of the treatment (based on adolescent report). | 9-week treatment period |
| Psychosocial Treatment Compliance Scale | Clinician-rated of participant overall treatment compliance. Scores range from 17-85 (17 5-point Likert scale items) with higher scores indicating greater treatment compliance. | 9-week treatment |
| Mobile Application Use | Frequency of mobile application (app) usage within the condition that received the mobile application, ranging from 0 to unlimited maximum with higher scores indicating more app usage. | 9-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Mobile Application Usability Scale | Mobile application (app) acceptability as rated on a 5-point scale (i.e., minimum = 1, maximum = 5) with higher values indicating greater acceptability | Measured at the end of the 9-week treatment period |
| Children's Depression Rating Scale, Revised |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Semel Institute | Los Angeles | California | 90095-8353 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40014504 | Derived | Weintraub MJ, Ichinose MC, Zinberg JL, Salimian A, Brown RD, Morgan-Fleming G, Gamarra JM, Tran T, Miklowitz DJ. A randomized trial of an app-enhanced group cognitive behavioral therapy for adolescents with mood or psychotic spectrum disorders. J Consult Clin Psychol. 2025 Mar;93(3):131-143. doi: 10.1037/ccp0000946. |
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196 youth phone screened
Phase I Open Trial:
33 youth assessed 31 youth enrolled
Phase II RCT:
66 youth assessed 60 youth enrolled
We recruited adolescents from two specialty outpatient programs at the UCLA Semel Institute - the Child and Adolescent Mood Disorders Program and the Center for the Assessment and Prevention of Prodromal Syndromes
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I Open Trial-Cognitive Behavioral Therapy (CBT) With Mobile App | The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices. |
| FG001 | Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. |
| FG002 | Phase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App | The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Skill Practice | Sum of all treatment skill practices completed through the course of the treatment (based on adolescent report). | Posted | Mean | Standard Deviation | treatment skill practices | 9-week treatment period |
|
21-weeks (i.e., from enrollment through completion of 21-week study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I Open Trial - Cognitive Behavioral Therapy (CBT) With Mobile App | The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices. |
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Most of the adolescents were diagnosed with a depressive spectrum disorder. Ratings of skill practice were made based on adolescent and clinician report, but there was no definitive method of confirming skill practice completion in the standard UP group, nor was there any examination of the proficiency/quality of skill practice across both conditions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Weintraub | UCLA Semel Institute | 3108251300 | mjweintraub@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2021 | Apr 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Measures depressive symptom severity. Scores range from 17-113 (14 7-point items and 3 5-point items) with higher scores indicating greater depressive severity. |
| Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
| Young Mania Rating Scale | Measure manic symptom severity. Scores range from 0-60 (7 5-point items and 4 9-point items) with higher scores indicating greater manic severity. | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
| Clinical Global Assessment Scale | Measures overall functioning on a 1-100 scale, with higher scores indicating better functioning. | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
| Clinical Global Impression | Measures overall clinical functioning from 1-7, with higher scores indicating greater psychiatric severity. | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
| Symptom Checklist 90 | Participant-reported psychiatry symptoms. Scores range from 0 - 360 (90 5-point Likert items) with higher scores indicating greater symptom severity. | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
| Difficulties With Emotion Regulation | Participant reported their difficulties with emotion regulation. Scores range from 36 - 180 (36 5-point items) with higher scores indicating greater distress. | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
| KINDL | Quality of life measure. Scores range from 0 - 120 (30 5-point items) with higher scores indicating better quality of life. | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
| Depression Anxiety & Stress Scale | Parent reported mood, anxiety and stress. Scores range from 0 - 63 (21 4-point items) with higher scores indicating greater distress. | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
| BG001 | Phase II RCT- Cognitive Behavioral Therapy (CBT)_no App | The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. |
| BG002 | Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices. |
| BG003 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Depressive mood disorder diagnosis | Number of Participants with a Depressive Mood Disorder Diagnosis | Number | Participants |
|
| OG001 | Phase II RCT-Cognitive Behavioral Therapy (CBT)_no App | The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. |
| OG002 | Phase II RCT- Cognitive Behavioral Therapy (CBT) With Mobile App | The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices. |
|
|
| Secondary | Mobile Application Usability Scale | Mobile application (app) acceptability as rated on a 5-point scale (i.e., minimum = 1, maximum = 5) with higher values indicating greater acceptability | No App condition did not receive the study app | Posted | Mean | Standard Deviation | units on a scale | Measured at the end of the 9-week treatment period |
|
|
|
| Primary | Psychosocial Treatment Compliance Scale | Clinician-rated of participant overall treatment compliance. Scores range from 17-85 (17 5-point Likert scale items) with higher scores indicating greater treatment compliance. | Posted | Mean | Standard Deviation | units on a scale | 9-week treatment |
|
|
|
| Primary | Mobile Application Use | Frequency of mobile application (app) usage within the condition that received the mobile application, ranging from 0 to unlimited maximum with higher scores indicating more app usage. | No App Condition did not receive the study app | Posted | Mean | Standard Deviation | units on a scale | 9-week treatment period |
|
|
|
| Secondary | Children's Depression Rating Scale, Revised | Measures depressive symptom severity. Scores range from 17-113 (14 7-point items and 3 5-point items) with higher scores indicating greater depressive severity. | The number analyzed in one or more rows differs from overall number analyzed due to attrition. | Posted | Mean | Standard Deviation | score on a scale | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
|
|
|
| Secondary | Young Mania Rating Scale | Measure manic symptom severity. Scores range from 0-60 (7 5-point items and 4 9-point items) with higher scores indicating greater manic severity. | The difference between the analysis population total between rows is due to study participant attrition. | Posted | Mean | Standard Deviation | score on a scale | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
|
|
|
| Secondary | Clinical Global Assessment Scale | Measures overall functioning on a 1-100 scale, with higher scores indicating better functioning. | The difference between the analysis population total between rows is due to study participant attrition. | Posted | Mean | Standard Deviation | score on a scale | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
|
|
|
| Secondary | Clinical Global Impression | Measures overall clinical functioning from 1-7, with higher scores indicating greater psychiatric severity. | The difference between the analysis population total between rows is due to study participant attrition. | Posted | Mean | Standard Deviation | score on a scale | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
|
|
|
| Secondary | Symptom Checklist 90 | Participant-reported psychiatry symptoms. Scores range from 0 - 360 (90 5-point Likert items) with higher scores indicating greater symptom severity. | The difference between the analysis population total between rows is due to study participant attrition. | Posted | Mean | Standard Deviation | score on a scale | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
|
|
|
| Secondary | Difficulties With Emotion Regulation | Participant reported their difficulties with emotion regulation. Scores range from 36 - 180 (36 5-point items) with higher scores indicating greater distress. | The difference between the analysis population total between rows is due to study participant attrition. | Posted | Mean | Standard Deviation | score on a scale | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
|
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|
| Secondary | KINDL | Quality of life measure. Scores range from 0 - 120 (30 5-point items) with higher scores indicating better quality of life. | The difference between the analysis population total between rows is due to study participant attrition. | Posted | Mean | Standard Deviation | units on a scale | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
|
|
|
| Secondary | Depression Anxiety & Stress Scale | Parent reported mood, anxiety and stress. Scores range from 0 - 63 (21 4-point items) with higher scores indicating greater distress. | The difference between the analysis population totals between rows is due to participant attrition. | Posted | Mean | Standard Deviation | score on a scale | Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period. |
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Phase II RCT - Cognitive Behavioral Therapy (CBT)_no App | The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Phase II RCT - Cognitive Behavioral Therapy (CBT) With Mobile App | The treatment delivered in this study is a modified version of the Unified Protocol (UP) for Adolescents, a CBT protocol for adolescents with emotional disorders. The treatment included nine, 90-minute weekly group sessions delivered in three modules - psychoeducation, behavioral skills, and cognitive skills. Participants in this conditions were also provided with access to a mobile application. The app was designed to help adolescents accomplish three treatment tasks: (1) review the treatment session content, (2) practice treatment skills, (3) and review and log their psychiatric symptoms and functional status (also known as the symptom check-in). Participants were able to review their treatment skill practice and track their symptoms in a section of the app called 'Review My Progress.' The app was used as a direct tool in the therapy session, as it was used by clinicians to review the treatment materials and have the participants practice the treatment skills in sessions. Additionally, the app served as a method to bridge sessions by allowing participants to review the prior session's content and practice treatment skills from their mobile device. The app also contained three primary engagement features: 1) text reminders to conduct weekly skill practice and symptom logging, 2) emojis that were earned upon completion of the weekly treatment skill practice, and 3) a skills streak counter indicating the consecutive weeks the participant has completed their skill practices. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Post-treatment |
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| 3-month follow-up |
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| Post-treatment |
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| 3-month follow-up |
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| Post-treatment |
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| 3-month follow-up |
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| Post-treatment |
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| 3-month follow-up |
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| End of treatment |
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| End of study |
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| End of treatment |
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| End of study |
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| End of treatment |
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| End of study |
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| End of treatment |
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| End of study |
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