SAFEGUARD Level Up Study
This project will evaluate the effectiveness of Level Up: Boost Your Life Skills ("Level Up"), a strengths based, military-specific life skills training program. The goal is to determine whether Level Up can decrease suicidal-related behaviors (SRBs) and other harmful behaviors, improve mental health, enhance job performance, and reduce early military separation. The Level Up program components will be made available to participants through an online platform or mobile app that can be downloaded onto their personal mobile devices. These training materials will help Soldiers learn and practice skills. The Level Up program will also involve personalized messages from a Level Up trainer and virtual booster sessions. Active duty Soldiers who are currently stationed at Fort Hood, Texas and are members of a participating platoon will be randomized to receive either Level Up or Training as Usual (TAU). Participants will complete baseline and follow up surveys 1, 3, and 6 months post-baseline.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
The first four years of service is widely known to be an especially high-risk period for suicide-related behaviors (SRBs) among Soldiers. In addition, most suicides occur among younger Soldiers aged 17-24 years-old (40%) and 25-29 years-old (26%) compared to older Soldiers (30-34 years-old= 18%, 35+ years-old = 16%). Situational stressors are prevalent among Soldiers who die by suicide, particularly in the areas of relationship problems (42%), workplace issues (29%), and financial issues (10%). These findings align with growing literature attesting to the direct relationship between such situational stressors and later SRBs in the military This time is also marked by high rates of other harmful behaviors and of early separation from the Army. The Army invests billions of dollars in recruiting and training, yet many new Soldiers leave the service early or experience serious events like suicidal behaviors. Exposure to situational stressors involving such areas of life as romantic relationships and finances increases risk for suicide and other harmful behaviors. Implementing universal training programs to prevent these types of negative outcomes before they arise have enormous potential to bolster the mental toughness of new Soldiers during this difficult transition. The proposed project aims to prevent suicide-related behaviors (SRBs) and other behaviors qualifying for a Serious Incident Report (SIR) through an innovative, universal life skills program delivered to Soldiers at Fort Hood. The proposed project will test the effectiveness of a recently developed, evidence-based training program designed to build life skills and coping strategies that can protect against suicide, other harmful behaviors, poor work performance, and premature separation. A majority of Soldiers in a typical operational unit are of enlisted rank and 30 years of age or younger, which as discussed earlier is the demographic of highest risk for suicide. Therefore, the purpose of this study will remain focused on evaluating the effectiveness of Level Up for reducing SRBs among early career Soldiers.
This project will evaluate the effectiveness of Level Up, a strengths based, military-specific life skills training program. The goal is to determine whether Level Up can decrease suicidal thoughts and behaviors, improve mental health, enhance job performance, and reduce early military separation. Previous studies show that building skills like stress management, problem-solving, and healthy communication can protect against SRBs and related problem behaviors. However, many of these programs failed to show long-term impact, partly due to limited engagement. Level Up is designed to overcome these limitations by combining interactive learning, mobile technology, personalized coaching, and on-demand virtual booster sessions. This hybrid format is intended to help Soldiers refresh their skills and engage with content at their preferred pace and rhythm. The Level Up program components include: 1) four weekly 2-hour live group sessions, 2) a mobile app/online platform/workbook with brief, interactive self-guided exercises in core skill areas (e.g., managing stress, tactical thinking, healthy relationships), 3) personalized coaching via messages from trained staff during the first month of app use, and 4) virtual booster sessions over one year, focused on practical domains like finances, leadership, promotion tips, and personal relationships. Soldiers will be randomized to receive either Level Up or TAU.
The Level Up program content draws from evidence-based psychological methods such as Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, and motivational coaching adapted to fit military culture and tailored to be relevant, accessible, and engaging for Soldiers. By equipping them with essential life skills and support, the program aims to reduce SRBs and other behaviors qualifying for SIRs, develop psychosocial skills, and increase career success and satisfaction.
If effective, Level Up could be implemented Army-wide as a universal prevention program to improve mental health, readiness, and retention. There are minimal risks as the interventions are educational, although some participants may experience brief emotional discomfort during skill practice or reflection. All participants can opt out at any time, and all are provided with resources and additional support as needed. This study could have a transformative impact on military suicide prevention efforts, especially during early service when Soldiers are most vulnerable. By evaluating this scalable program in a large, real-world setting, the research will provide clear evidence about its benefits for reducing suicide and improving readiness. Results will also support development of predictive tools to identify which Soldiers may benefit most from added support. Findings will be shared across the Department of War to inform policy, training, and future resilience-building programs-ultimately improving the health, performance, and quality of life of Soldiers across the Force.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Level Up Study Team
- Número de teléfono: 301-660-6297
- Correo electrónico: level-up-study-ggg@usuhs.edu
Ubicaciones de estudio
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Texas
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Fort Hood, Texas, Estados Unidos, 76544
- Reclutamiento
- 3ABCT, 1st Cavalry Division
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Contacto:
- 3ABCT Operations Officer
- Número de teléfono: 410-491-8560
- Correo electrónico: dalton.r.coe.mil@army.mil
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Active duty Soldiers Active duty Soldiers who are currently stationed at Fort Hood, Texas and are members of a participating platoon.
Exclusion Criteria:
- Soldiers who are not present at the time of recruitment
- Soldiers who are under the age of 18 years old
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: Level Up Program
The Level Up program is a hybrid intervention combining interactive learning, mobile/online technology, personalized coaching, and on-demand virtual booster sessions. The evidence-based training program was designed to build life skills and coping strategies that can protect against suicide, other harmful behaviors, poor work performance, and premature separation during a Soldier's first duty assignment. |
The Level Up program components include:
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Sin intervención: Training As Usual (TAU)
TAU will serve as the study control condition. TAU will consist of other mandatory training activities determined by their unit. TAU activities include access to a variety of standard Army training resources at Fort Hood that support the mental health and well-being of Soldiers and lower risk of harmful behaviors. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The occurrence of any harmful behavior
Periodo de tiempo: Within the 12 months after intervention randomization
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The occurrence of any harmful behavior, either self-reported in follow up surveys or administratively reported |
Within the 12 months after intervention randomization
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The occurrence of any suicide-related behavior
Periodo de tiempo: Within the 12 months after intervention randomization
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The occurrence of any suicide-related behavior, either self-reported in follow up surveys or administratively reported |
Within the 12 months after intervention randomization
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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La ocurrencia de cualquier separación prematura del servicio
Periodo de tiempo: Dentro de los 12 meses posteriores a la aleatorización de la intervención
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Dentro de los 12 meses posteriores a la aleatorización de la intervención
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Bajo rendimiento indicado ya sea por reprimendas por escrito, designaciones en el NCOER, un plan de acción correctivo, formación de recuperación, acciones de marcación, degradación, Artículo 15 o prohibición de reenganche
Periodo de tiempo: Dentro de los 12 meses posteriores a la aleatorización de la intervención
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Dentro de los 12 meses posteriores a la aleatorización de la intervención
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Personal deployment readiness
Periodo de tiempo: Within the 6 months after intervention randomization
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Walter Reed Army Institute of Research Land Combat Survey; Scale ranges from 4-20; Higher scores indicate higher perceived readiness |
Within the 6 months after intervention randomization
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Emotionality
Periodo de tiempo: Within the 6 months after intervention randomization
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Emotion Reactivity Scale (ERS) ; Scale ranges from0-4; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Job satisfaction
Periodo de tiempo: Within the 6 months after intervention randomization
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3-item Job Satisfaction Scale; Scale ranges from 3-15; Higher scores indicate higher perceived job satisfaction |
Within the 6 months after intervention randomization
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Depression symptom severity
Periodo de tiempo: Within the 6 months after intervention randomization
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Patient Health Questionnaire-2 (PHQ-2); Scale ranges from 0-8; Higher scores indicate more severe symptoms |
Within the 6 months after intervention randomization
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Anxiety symptom severity
Periodo de tiempo: Within the 6 months after intervention randomization
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Generalized Anxiety Disorder-2 (GAD-2); Scale ranges from 0-8; Higher scores indicate more severe symptoms |
Within the 6 months after intervention randomization
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Incidence of traumatic brain injuries
Periodo de tiempo: Within the 6 months after intervention randomization
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Number of traumatic brain injuries; based on the Army STARRS Surveys; No scale range; number indicates greater number of traumatic brain injuries |
Within the 6 months after intervention randomization
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Lifetime history of various mental/emotional health problems
Periodo de tiempo: Within the 6 months after intervention randomization
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Family History Screen (FHS); Scale ranges from 0-1; 0=No; 1=Yes |
Within the 6 months after intervention randomization
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Chronic stress severity
Periodo de tiempo: Within the 6 months after intervention randomization
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Personal Life Stress Scale (PLS); Scale ranges from 0-50; Higher scores indicate greater chronic stress severity |
Within the 6 months after intervention randomization
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Mental toughness
Periodo de tiempo: Within the 6 months after intervention randomization
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Sports Mental Toughness Questionnaire (SMTQ); Scale ranges from 5-25; Higher scores indicate higher confidence & constancy |
Within the 6 months after intervention randomization
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History of suicidal ideation, plan, & attempt
Periodo de tiempo: Within the 6 months after intervention randomization
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Columbia-Suicide Severity Rating Scale (C-SSRS) Full scale Baseline/Screening; Scale ranges from 0-1 0=No; 1=Yes |
Within the 6 months after intervention randomization
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Positive social networks
Periodo de tiempo: Within the 6 months after intervention randomization
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Supportive & Negative Social Interaction Scale (SIS); Scale ranges from 0-8; Higher scores indicate more positive/negative social support |
Within the 6 months after intervention randomization
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Negative social networks
Periodo de tiempo: Within the 6 months after intervention randomization
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Supportive & Negative Social Interaction Scale (SIS); Scale ranges from 0-8; Higher scores indicate more positive/negative social support |
Within the 6 months after intervention randomization
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Mattering/belonging
Periodo de tiempo: Within the 6 months after intervention randomization
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General Mattering Scale; Scale ranges from 0-20; Higher scores indicate higher perceived mattering to others |
Within the 6 months after intervention randomization
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Loneliness
Periodo de tiempo: Within the 6 months after intervention randomization
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3-Item Loneliness Screener; Scale ranges from 0-16; Higher scores indicate more frequency-severity of loneliness |
Within the 6 months after intervention randomization
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Adverse childhood events & trauma
Periodo de tiempo: Within the 6 months after intervention randomization
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Childhood Trauma Questionnaire - Short Form (CTQ-SF) ; Scale ranges from 0-44; Higher scores indicate more childhood maltreatment |
Within the 6 months after intervention randomization
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Conscientiousness
Periodo de tiempo: Within the 6 months after intervention randomization
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Big Five Inventory (BFI)16 & Personality Inventory for DSM-5 Brief Form (PID-5-BF); Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
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Mastery
Periodo de tiempo: Within the 6 months after intervention randomization
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Pearlin & Schooler's Psychological Coping Resources Measure; Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
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Openness
Periodo de tiempo: Within the 6 months after intervention randomization
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120-item International Personality Item Pool (IPIP); Scale ranges from 0-4; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
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Problem-solving ability
Periodo de tiempo: Within the 6 months after intervention randomization
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Social Problem Solving Inventory-Revised (SPSI-R); Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
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Psychological well-being
Periodo de tiempo: Within the 6 months after intervention randomization
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Flourishing Scale; Scale ranges from 0-12; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
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Resilience
Periodo de tiempo: Within the 6 months after intervention randomization
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Army STARRS Resilience Scale; Scale ranges from 0-16; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
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Self-esteem
Periodo de tiempo: Within the 6 months after intervention randomization
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Rosenberg Self-Esteem Scale; Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait |
Within the 6 months after intervention randomization
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Anxious, Cyclothymic, Depressive, & Hyperthymic temperament
Periodo de tiempo: Within the 6 months after intervention randomization
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Revised NEO Personality Inventory (NEO-PI-R) & the Temperament Evaluation of Memphis, Pisa, Paris & San Diego-autoquestionnaire version (TEMPS-A); Scale ranges from 0-8 for each temperament; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Borderline personality
Periodo de tiempo: Within the 6 months after intervention randomization
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McLean Screening Instrument for Borderline Personality Disorder; Scale ranges from 0-16; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Anger-hostility
Periodo de tiempo: Within the 6 months after intervention randomization
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Big Five Inventory (BFI)16 & Personality Inventory for DSM-5 Brief Form (PID-5-BF); Scale ranges from 0-8; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Impulsivity/negative urgency
Periodo de tiempo: Within the 6 months after intervention randomization
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Impulsive Behavior Scale - Short Form (SUPPS-P); Scale ranges from 0-8; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Introversion
Periodo de tiempo: Within the 6 months after intervention randomization
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Eysenck Personality Questionnaire - Brief Version (EPQ-BV)28 & Revised NEO Personality Inventory (NEO-PI-R); Scale ranges from 0-8; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Fearlessness about death
Periodo de tiempo: Within the 6 months after intervention randomization
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Acquired Capability for Suicide Scale; Scale ranges from 0-4; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Self-conscious
Periodo de tiempo: Within the 6 months after intervention randomization
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Widiger Five-Factor Rating Form - Revised31 & NEO Five-Factor Inventory (NEO-FFI); Scale ranges from 0-8; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Vulnerability
Periodo de tiempo: Within the 6 months after intervention randomization
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NEO Five-Factor Inventory (NEO-FFI); Scale ranges from 0-4; Higher scores indicate higher of each maladaptive trait |
Within the 6 months after intervention randomization
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Frequency of risky behaviors
Periodo de tiempo: Within the 6 months after intervention randomization
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Unit Risk Inventory (URI); Scale ranges from 0-1; 0=Never; 1=At least less than once a month |
Within the 6 months after intervention randomization
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Thomas H Nassif, PhD, Uniformed Services University of the Health Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- USUHS.2025-162
- Federal Award # HU00012520025 (Otro número de subvención/financiamiento: Assistant Secretary of War for Health Affairs)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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