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Mystical Experiences Without Psychedelics and How Integration Improves Well-Being in Adults

7 de maio de 2026 atualizado por: Baylor University

Mystical Experiences Without Psychedelics: The Nature of Peak Spiritual Experiences and How Integration Leads to Human Flourishing

The goal of this clinical trial is to evaluate whether a guided, non-drug spiritual intervention can facilitate mystical-type experiences and improve well-being in Christian adults.

The main questions it aims to answer are:

  • Does the guided spiritual intervention produce measurable mystical experiences?
  • Does participation in the intervention and assigned integration program lead to improvements in well-being over time?

Researchers will compare a Christian-based integration program to a structured control integration program to determine whether Christian-based integration leads to greater improvements in well-being.

Participants will:

  • Complete baseline questionnaires assessing spiritual experiences, religiosity, and well-being
  • Complete one in-person session of the "guided invocation for mystical experience"
  • Be randomly assigned to complete either a Christian-based or control integration program for 4 weeks
  • Complete follow-up assessments at 1 month and 2 months

Visão geral do estudo

Status

Ainda não está recrutando

Descrição detalhada

Mystical-type experiences involve acute alterations in consciousness characterized by features such as perceived unity, transcendence of time and space, positive affect, and a sense of encountering ultimate reality. These experiences have been associated with sustained changes in psychological well-being and meaning-making. Most contemporary empirical research has examined such experiences in the context of psychedelic substances; however, non-pharmacological methods for facilitating these experiences remain understudied despite historical precedent and preliminary evidence of feasibility.

This study evaluates a standardized, non-drug intervention, the Guided Invocation for Mystical Experience (GIME), designed to facilitate mystical-type experiences through induction of a non-ordinary state of consciousness. The intervention integrates controlled breathing techniques, guided imagery, and structured verbal suggestion. These components are intended to increase attentional absorption, reduce external sensory input, and promote alterations in perception and self-referential processing consistent with prior models of altered states of consciousness.

The intervention is informed by a conceptual framework in which the occurrence of mystical-type experiences is influenced by three primary factors: (1) induction of a non-ordinary state of consciousness, (2) contextual variables (e.g., environmental setting, expectancy), and (3) structured evocative instructions ("invitation"). The protocol standardizes these elements to enhance reproducibility and reduce variability across participants.

The GIME session is administered in person by a trained practitioner using a manualized procedure. The session includes (1) preparatory instructions and rapport establishment, (2) a structured breathing protocol designed to facilitate physiological and attentional changes, (3) guided imagery and verbal suggestions targeting core dimensions of mystical-type experiences (e.g., unity, sacredness, positive affect), and (4) a brief period of unstructured experiential processing followed by re-alerting procedures. The intervention is designed to be completed within a single session.

Following the intervention, participants are randomized to one of two post-session integration conditions. Integration is conceptualized as an active cognitive and behavioral process through which individuals interpret and incorporate the experience into their existing belief systems and daily functioning. The experimental condition consists of a structured, Christian-oriented integration program including psychoeducational materials, guided reflection exercises, brief recorded audio sessions, and weekly phone calls from the interventionist. The control condition consists of a structurally equivalent program matched for duration, attention, and task engagement but without religious or spiritual content. This comparison allows for evaluation of the specific effects of faith-based integration practices.

The study also examines potential moderating variables influencing both the occurrence and intensity of mystical-type experiences, including baseline religiosity, spirituality, and trait-level factors associated with absorption and responsiveness to altered states of consciousness. These variables are hypothesized to predict variability in experiential outcomes and downstream effects.

This trial is designed to (1) evaluate the feasibility and efficacy of a manualized, non-pharmacological intervention for facilitating mystical-type experiences, (2) characterize the phenomenology of these experiences in a religious sample, and (3) assess the extent to which structured integration practices influence the durability of changes in well-being over time.

Tipo de estudo

Intervencional

Inscrição (Estimado)

120

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

    • Texas
      • Waco, Texas, Estados Unidos, 76112
        • Mind-Body Medicine Research Laboratory
        • Contato:
        • Subinvestigador:
          • Sarah Schnitker, PhD
        • Subinvestigador:
          • Devan Stahl, PhD
        • Subinvestigador:
          • Cameron Alldredge, PhD
        • Subinvestigador:
          • Erin Moniz, DMin
        • Subinvestigador:
          • Aaron Zimmerman, MDiv

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • age 18 years or older;
  • active Christian faith;
  • willing to experience hypnosis;
  • English-speaking; able to complete one in-person session and 1- and 2-month follow-up assessments.

Exclusion Criteria:

  • prior psychedelic use;
  • severe mental illness (e.g., schizophrenia, bipolar disorder, psychosis, borderline personality disorder);
  • unwillingness to experience hypnosis;
  • inability to complete study procedures

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Structured Christian Integration
Participants assigned to the structured Christian integration condition will engage in a 4-week, integration program designed to facilitate reflection on and incorporation of their peak spiritual experience into their existing religious framework. The intervention includes four modules with psychoeducational materials, structured activities grounded in Christian teachings, and weekly phone calls with the interventionist. Participants will use a toolkit with weekly writing prompts and recorded audio sessions (14-22 minutes) focused on themes such as revisiting and reflection, awareness and nature, love and connection, and transformation. Participants will engage with materials regularly (e.g., audio sessions at least four times per week) and submit written responses at the end of each module. The program is standardized and designed to support ongoing cognitive and emotional processing and integration into daily life and religious practice.
Participants will complete a single, in-person Guided Invocation for Mystical Experience (GIME) session conducted by a trained practitioner using a standardized protocol. The session includes an initial briefing and rapport-building period, followed by a structured breathing exercise (approximately 8 minutes) designed to facilitate a non-ordinary state of consciousness. Participants then receive guided imagery and verbal suggestions intended to promote relaxation, absorption, and experiential openness. The practitioner delivers a standardized script targeting features commonly associated with mystical-type experiences (e.g., unity, positive affect, and altered perception of time and space). The session includes a brief period of silent introspection, followed by re-alerting procedures. The total session duration is approximately 60 minutes.
Comparador Ativo: Structured Control Integration
Participants assigned to the structured control integration condition will engage in a 4-week, self-guided program designed to match the structure, duration, and level of engagement of the Christian integration condition. The intervention includes four modules with psychoeducational materials, structured poetry analysis without religious or spiritual content, and weekly phone calls with the interventionist. Participants will use a toolkit with weekly writing prompts and audio sessions focused on various analyses (e.g., content, structure, imagery, symbolism) of poetry. Participants will engage with materials regularly (e.g., audio sessions at least four times per week) and submit written responses at the end of each module. The program is standardized and designed as a structurally equivalent control condition and no specific benefit is anticipated.
Participants will complete a single, in-person Guided Invocation for Mystical Experience (GIME) session conducted by a trained practitioner using a standardized protocol. The session includes an initial briefing and rapport-building period, followed by a structured breathing exercise (approximately 8 minutes) designed to facilitate a non-ordinary state of consciousness. Participants then receive guided imagery and verbal suggestions intended to promote relaxation, absorption, and experiential openness. The practitioner delivers a standardized script targeting features commonly associated with mystical-type experiences (e.g., unity, positive affect, and altered perception of time and space). The session includes a brief period of silent introspection, followed by re-alerting procedures. The total session duration is approximately 60 minutes.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Frequency of a Complete Mystical Experience as Assessed by the Mystical Experience Questionnaire
Prazo: Immediately following the in-person guided invocation for mystical experience session

Frequency of complete mystical experiences will be assessed using the 30-item Mystical Experience Questionnaire (MEQ30), a validated self-report measure designed to assess key phenomenological features of mystical-type experiences. The MEQ30 includes four empirically derived subscales: Mystical, Positive Mood, Transcendence of Time and Space, and Ineffability. Participants rate the extent to which each item describes their experience. Higher scores reflect greater endorsement of mystical-type features.

To determine whether a participant had a complete mystical experience, scores will be calculated for each of the four subscales and expressed as a percentage of the maximum possible score for that subscale. A complete mystical experience is defined as meeting or exceeding 60% of the maximum possible score on all four MEQ30 subscales. The frequency of complete mystical experiences will then be calculated as the proportion of participants who meet this criteria.

Immediately following the in-person guided invocation for mystical experience session
PERMA Well-Being Scale
Prazo: Baseline, 1 month, and 2 months post-intervention
The PERMA Well-Being Scale measures five dimensions of well-being-Positive Emotion, Engagement, Relationships, Meaning, and Accomplishment-based on Martin Seligman's PERMA model. The scale contains 23 items, with 3-5 items per subdomain, scored on a Likert scale. Butler and Kern (2016) established the scale's internal consistency (α > .80) and construct validity.
Baseline, 1 month, and 2 months post-intervention
Ryff Psychological Wellbeing Scale
Prazo: Baseline, 1 month, and 2 months post-intervention
The Ryff Psychological Wellbeing Scale (PWB) assesses six domains of well-being: autonomy, environmental mastery, personal growth, positive relationships, purpose in life, and self-acceptance. It includes 42 items, scored on a Likert scale, with shorter versions available. Psychometric evaluation revealed high internal consistency (α > .80) and test-retest reliability across diverse populations (Ryff & Keyes, 1995). Example items include, "I like most parts of my personality" (self-acceptance) and "I am not afraid to voice my opinions, even when they are in opposition to most people" (autonomy).
Baseline, 1 month, and 2 months post-intervention
Multidimensional Existential Meaning Scale
Prazo: Baseline, 1 month, and 2 months post-intervention
The Multidimensional Existential Meaning Scale (MEMS) measures existential meaning across three dimensions: coherence, purpose, and mattering. The scale consists of 15 items rated on a 7-point Likert scale ranging from "strongly disagree" to "strongly agree." Higher scores indicate a greater sense of existential meaning. Psychometric evaluations by George and Park (2017) demonstrated excellent internal consistency (α > .90) and robust construct validity. Example items include, "I understand how my life fits into the larger picture," "I feel that my life has a clear sense of purpose," and "I believe that my life is significant and matters." This scale is particularly suited for studies exploring the depth and breadth of meaning in individuals' lives.
Baseline, 1 month, and 2 months post-intervention
Flourishing Scale
Prazo: Baseline, 1 months, and 2 months post-intervention
The Flourishing Scale measures social-psychological prosperity across eight items that assess areas such as self-esteem, purpose, and optimism. Items are rated on a 7-point Likert scale, with higher scores indicating greater well-being. Diener et al. (2010) demonstrated excellent internal consistency (α > .85). An example item is, "I lead a purposeful and meaningful life." This concise yet comprehensive scale is widely used in studies of well-being interventions.
Baseline, 1 months, and 2 months post-intervention
Quality of Life Rating Scale
Prazo: Baseline, 1 month, and 2 months post-intervention
The Quality of Life Rating Scale evaluates life satisfaction across physical, emotional, and social domains. The 16-item measure uses a 7-point Likert scale, with higher scores reflecting better quality of life. Burckhardt and Anderson (2003) reported strong psychometric properties, including internal consistency (α > .80). A sample item is, "To what degree do you feel your physical health limits your activities of daily living?"
Baseline, 1 month, and 2 months post-intervention
Spiritual Transcendence Scale
Prazo: Baseline, 1 month, and 2 months post-intervention
The Spiritual Transcendence Scale measures the degree of an individual's sense of connectedness to a higher reality. The scale contains 24 items across three subdomains: prayer fulfillment (α = .85), universality (α = .85), and connectedness (α = .65). Piedmont (1999) reported good internal consistency on three subscales. Example items include, "I find strength in my religion or spirituality" (prayer fulfillment) and "I feel a sense of oneness with all humanity" (universality).
Baseline, 1 month, and 2 months post-intervention
Religious and Spiritual Struggles Scale
Prazo: Baseline, 1 month, and 2 months post-intervention
The Religious and Spiritual Struggles Scale (RSSS) measures the extent and nature of struggles individuals may have with their religion or spirituality. The scale includes 26 items and identifies six distinct domains of struggle: divine, demonic, interpersonal, moral, doubt, and ultimate meaning. Items are rated on a Likert scale, typically ranging from "not at all" to "a great deal," indicating the degree of struggle experienced. Exline et al. (2014) demonstrated strong internal consistency across subscales (α > .80) and solid construct validity in both clinical and non-clinical populations. Sample items include, "I felt angry at God," "I struggled with feeling rejected or unloved by my religious community," and "I questioned whether my life really matters."
Baseline, 1 month, and 2 months post-intervention
Attachment to God Scale
Prazo: Baseline, 1 month, and 2 months post-intervention
The Attachment to God Scale (AGS) assesses individual differences in the quality of one's relationship with God, conceptualized through the lens of attachment theory. The scale consists of 9 items measuring two core dimensions: Anxiety (e.g., fear of abandonment by God) and Avoidance (e.g., discomfort with closeness to God). Participants rate each item on a 7-point Likert scale ranging from "strongly disagree" to "strongly agree." Higher scores on each subscale indicate greater attachment-related insecurity in the corresponding domain. Rowatt and Kirkpatrick (2002) demonstrated high internal consistency (α > .85) for both subscales and strong construct validity, including associations with religious coping, mental health, and interpersonal relationships.
Baseline, 1 month, and 2 months post-intervention
Self-Compassion Scale
Prazo: Baseline, 1 month, and 2 months post-intervention
The Self-Compassion Scale (SCS) is a 26 question self-report scale designed to measure kindness and understanding toward oneself in instances of pain or failure (Neff, 2003). It has six factors including self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. The internal consistency was α = .92. A non-significant correlation of r = .05 (p = .34) was found between the SCS and the Marlowe-Crowne Social Desirability scale. The SCS was also found to have good construct and discriminant validity as well as test-retest reliability (r = .93).
Baseline, 1 month, and 2 months post-intervention

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Brief Multidimensional Measure of Religiousness/Spirituality
Prazo: Baseline
The Brief Multidimensional Measure of Religiousness/Spirituality (BMMRS) is a comprehensive tool designed to assess various dimensions of religious and spiritual life. The measure includes 29 items spanning multiple subdomains, such as religious practices (e.g., attendance at services, prayer), spiritual beliefs (e.g., beliefs in higher powers), coping strategies, and spiritual experiences. Items are rated on Likert scales or categorical responses, depending on the subdomain. The BMMRS has demonstrated strong psychometric properties, with internal consistency typically exceeding α = .80 across its subscales and evidence of validity in diverse cultural and religious populations.
Baseline
Modified Tellegen Absorption Scale
Prazo: Baseline
The Modified Tellegen Absorption Scale (MODTAS) is a revised version of the original Tellegen Absorption Scale, designed to assess an individual's tendency to become fully engaged in sensory and imaginative experiences. It includes 34 items rated on a 5-point Likert scale from "not at all true" to "extremely true," improving upon the original true/false format to enhance psychometric robustness. The MODTAS measures various aspects of experiential absorption, including responsiveness to engaging stimuli, imaginative involvement, and altered states of consciousness. Jamieson (2005) reported strong internal consistency (α > .90) and construct validity in relation to hypnotizability and imaginative suggestibility.
Baseline
Qualitative Characteristics of the Experience
Prazo: Immediately following the in-person guided invocation for mystical experience session.
Thematic analysis of participant-reported experiences collected via post-session interviews.
Immediately following the in-person guided invocation for mystical experience session.
Mysticism Scale
Prazo: Immediately following the in-person guided invocation for mystical experience session
The Mysticism Scale evaluates mystical experiences, focusing on dimensions such as ineffability, transcendence of time and space, and unity. It includes 32 items, rated on a Likert scale, and has been validated in multiple cultural contexts (Hood et al., 2001). Hood (1975) reported strong psychometric properties, with internal consistency above α = .80. An example item is, "I have had an experience where everything seemed to disappear, leaving only a sense of unity."
Immediately following the in-person guided invocation for mystical experience session
Daily Spiritual Experience Scale
Prazo: Baseline
The Daily Spiritual Experience Scale (DSES) measures the frequency of spiritual experiences in everyday life, focusing on feelings of connection, awe, gratitude, and a sense of divine presence. The scale includes 16 items rated on a 6-point Likert scale ranging from "many times a day" to "never or almost never," with higher scores reflecting greater frequency of daily spiritual experiences. Psychometric evaluations by Underwood and Teresi (2002) demonstrated excellent internal consistency (α > .90) and strong validity across diverse religious and non-religious populations. Sample items include, "I feel God's presence" and "I feel a deep inner peace or harmony." The DSES is particularly suited for studies investigating spirituality as an experiential and moment-to-moment construct.
Baseline
Religious Commitment Inventory-10
Prazo: Baseline
The Religious Commitment Inventory-10 (RCI-10) assesses the degree to which religious beliefs and practices influence an individual's daily life and decisions. The scale consists of 10 items rated on a 5-point Likert scale from "not at all true of me" to "totally true of me." Higher scores indicate greater religious commitment. Worthington et al. (2003) reported excellent psychometric properties, including high internal consistency (α > .90) and predictive validity for religious behavior and its impact on psychological outcomes.
Baseline
Mysticism Scale - Lifetime
Prazo: Baseline, 1 month, and 2 months post-intervention
The Mysticism Scale - Lifetime measures the frequency and intensity of mystical experiences throughout a person's life. Based on the regular Mysticism Scale, the lifetime scale comprises 32 items divided into three subdomains: introvertive mysticism, extrovertive mysticism, and interpretation of mystical experiences. It evaluates core aspects such as unity, ineffability, and transcendence of time and space. Hood (1975) validated the measure, reporting high internal consistency (α > .80) and demonstrating its cross-cultural applicability in later studies (Hood et al., 2001).
Baseline, 1 month, and 2 months post-intervention
5-Dimensional Altered States of Consciousness Rating Scale
Prazo: Immediately after the in-person guided invocation for a mystical experience session
The 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) assesses altered states across five dimensions: oceanic boundlessness, anxious ego dissolution, visionary restructuralization, auditory alterations, and vigilance reduction. The scale contains 94 items, rated on a visual analog scale. Dittrich (1998) reported robust psychometric properties, with internal consistency exceeding α = .85. Sample items include, "I felt an all-encompassing unity" and "I perceived the world in a fundamentally new way."
Immediately after the in-person guided invocation for a mystical experience session
Persisting Effects Questionnaire
Prazo: 1 month and 2 months post-intervention
The Persisting Effects Questionnaire (Griffiths et al., 2006) assesses long-term changes in attitudes, moods, and behaviors following significant mystical experiences. The 89-item measure evaluates changes in spirituality, relationships, and life satisfaction.
1 month and 2 months post-intervention
Behavioral Indicator of Prosociality
Prazo: 1 month and 2 months post-intervention
Participants will be given an option to donate some or all of their monetary compensation. Participants will be informed of which charitable organizations their donation will benefit. This will be measured in dollar amounts and compared between the experimental conditions.
1 month and 2 months post-intervention
Personal Significance Questions
Prazo: 1 month and 2 months post-intervention

The following personal significance questions are based on those used in psychedelic-assisted therapy trials (e.g., Griffiths et al., 2006)

How personally meaningful was the experience you had during your in-person session?

Participants will respond with one of 8 responses ranging from "no more than routine, everyday experiences" to "the single most meaningful experience of my life"

Indicate the degree to which the experience was spiritually significant to you.

Participants will response with one of 6 responses ranging from "not at all" to "the single most spiritually significant experience of my life".

To what degree did the experience and your contemplation of the experience lead to changes in your sense of personal well-being or life satisfaction?

Participants will respond on a 7-point Likert scale ranging from "increased very much" to "decreased very much".

1 month and 2 months post-intervention
Brief Remote Elkins-Alldredge Test of Hypnotizability
Prazo: 1 month post-intervention
The Brief Remote Elkins-Alldredge Test of Hypnotizability is a virtual assessment based on the gold standard measure for hypnotizability, the Elkins Hypnotizability Scale (Muñiz et al., in press). The EHS is a 6 item, therapist-administered scale of hypnotizability. The six items include arm heaviness or immobilization, arm levitation, imagery involvement or dissociation, positive hallucination of the smell of a rose, positive hallucination of a block, and posthypnotic amnesia. Scoring is based on the respondent's subjective experience and observable behavioral responses which are summed to obtain a total score (range 0-12) with higher scores indicating greater hypnotizability. Categorizations of hypnotizability include low (1-4), moderate (5-8), and high (8-12). Validation studies have demonstrated that the EHS has good internal consistency in an outpatient clinical sample (a = .85; Elkins, 2014) and in a college student sample (a = .78; Kekecs et al., 2016).
1 month post-intervention
Hospital Anxiety and Depression Scale
Prazo: Baseline, 1 month, and 2 months post-intervention
The Hospital Anxiety and Depression Scale (HADS) assesses the symptom severity of anxiety disorders and depression (Zigmond & Snaith, 1983). It has strong internal consistency. A recent literature review of 747 papers found an average Cronbach's alphas of .83 for the anxiety subscale and .82 for the depression subscale. It also has acceptable to strong convergent validity. It performs well as an assessment tool in somatic, psychiatric, and primary care patients as well as in the general population (Bjelland et al., 2002).
Baseline, 1 month, and 2 months post-intervention

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Acceptability questions
Prazo: Immediately after the in-person guided invocation for a mystical experience session

If given the opportunity, how likely would you be to participate in this activity again?

How likely are you to recommend this experience to others?

Both of these questions will be answered on a 0-10 scale where 0 = not at all likely and 10 = extremely likely.

Immediately after the in-person guided invocation for a mystical experience session
Self-identified spirituality
Prazo: Baseline, 1 month, and 2 months post-intervention

In whatever way you define it, how spiritual do you consider yourself to be?

Participants will respond to this question on a 0-100 visual analog scale where 0 = not at all spiritual and 100 = extremely spiritual.

Baseline, 1 month, and 2 months post-intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Gary Elkins, PhD, Baylor University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de abril de 2026

Conclusão Primária (Estimado)

30 de abril de 2027

Conclusão do estudo (Estimado)

1 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

7 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de maio de 2026

Primeira postagem (Real)

13 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • TWCF-2024-34203 (Outro identificador: Templeton World Charity Foundation)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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