Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy (T-ENDO)
Testing Efficacy of Psychotherapeutic Interventions in Patients With ENDOmetriosis: A Randomized Controlled Trial Comparing Cognitive Behavioral Therapy vs Acceptance and Commitment Therapy
The aim of the present study is to compare two types of psychotherapeutic interventions in women with endometriosis and/or adenomyosis: cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT). The study will examine whether these therapies differ in their effects on health-related quality of life. We hypothesis a different effect on health related quality of life pain-related difficulties, emotional well-being, fatigue, sexual functioning, and other aspects of daily life since the two interventions aim at different purposes and results. CBT is based on restructuring of thought, thus the aim and the result are activating a change. ACT is aimed at increasing acceptance of the existing condition in order to cope better with it. The literature indeed suggested that the two approach can produce different effects in the same clinical population.
The study will include women with a recent diagnosis and women who have been living with the diagnosis for a longer time.
Participants will be randomly assigned to receive either CBT or ACT. Both groups will attend eight therapy sessions, held every two weeks. Participants will complete online questionnaires before treatment, after session 4, after treatment, and 3 and 6 months after treatment. The questionnaires will assess quality of life, pain, emotional well-being, and other aspects of health and daily functioning.
The study will take place at the Endometriosis Centre of Careggi University Hospital in Florence, Italy. Eligible participants must be women aged 18 or older who are receiving care at this centre and have a confirmed diagnosis of endometriosis and/or adenomyosis based on medical assessment. They must have been on stable medication treatment for at least 3 months, speak and write Italian fluently, have internet access, and be able to provide informed consent. Women with a current psychiatric diagnosis or who are currently receiving psychotherapy are not eligible to participate in the study.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Endometriosis (ENDO) is a chronic inflammatory disease affecting 4-18% of women with symptoms such as dyspareunia, dysmenorrhea, dyschezia, low back pain, chronic pelvic pain and gastrointestinal manifestations. Meta-analyses showed higher anxiety, depression, and poorer quality of life in women with ENDO compared to healthy controls. Cross-sectional studies suggested that a psychological burden linked to pain and factors such as pain catastrophizing, low pain acceptance, self-criticism, psychological inflexibility (PI), maladaptive coping strategies, sexual dysfunction, maladaptive illness perceptions, early life adversity, negative body image, fatigue and low psychological flexibility. Long-term exposure to ENDO has been associated with an increased risk of developing more severe psychological distress over time. Therefore, accounting for time since diagnosis appears important when examining psychological outcomes in this population.
Psychological interventions such as psychoeducation, mindfulness-based techniques, acceptance and commitment therapy (ACT), and cognitive behavioral therapy (CBT) have shown promising results in improving pain, quality of life, anxiety, and depression in ENDO. However, this literature is sparse, and the methods used are heterogeneous. Furthermore, in these studies only pain, anxiety, depression, and quality of life have been investigated as outcomes measures although evidence from studies on other chronic illnesses and chronic pain conditions suggests that CBT and ACT interventions could also provide benefits in addressing self-criticism, eating-related psychopathology, psychological flexibility, maladaptive coping strategies, sexual dysfunction, maladaptive illness perceptions, fatigue, early life adversity, and negative body image. Furthermore, no studies to date have directly compared ACT-based and CBT-based interventions in women with ENDO. Given their different theoretical models and therapeutic targets, comparing the two interventions may help clarify their potential role in improving psychological adjustment and quality of life in ENDO.
Overall, studying the potential benefits of psychotherapeutic interventions based on CBT versus ACT components using rigorous methods, while accounting for illness duration, may help shed light on complementary therapeutic options for women with ENDO and on ways to modify their psychological burden trajectories, while also extending current knowledge by broadening the range of psychological outcomes assessed beyond commonly studied indicators such as pain, emotional distress, and quality of life.
The aim of the present study is to compare the effects of CBT-based versus ACT-based psychotherapeutic interventions on health-related quality of life in women with endometriosis and/or adenomyosis, considering both women with a recent diagnosis (≤12 months from diagnosis; Study 1) and those with a long-lasting diagnosis (>12 months from diagnosis; Study 2). This operational definition of "long-lasting" conditions is consistent with the literature on chronic illness adaptation, which conceptualizes the first year post-diagnosis as an early adjustment phase, whereas persistence beyond this period reflects a more established chronic illness trajectory and stabilized adaptation processes.
The study will also investigate the effects of the two interventions on a broad range of secondary outcomes in both Study 1 and Study 2, including endometriosis-specific quality of life, pain-related disability, psychological distress, psychological flexibility and related processes, coping strategies and emotion regulation, illness-related attitudes and perceptions, sexual functioning, life satisfaction, psychological well-being, and other clinical and psychological dimensions.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Fiammetta Cosci
- Telefonnummer: 0552755066
- E-Mail: fiammetta.cosci@unifi.it
Studienorte
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FI
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Florence, FI, Italien, 50134
- Endometriosis Center, Department of Obstetrics and Gynecology, Careggi University Hospital (AOUC)
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Kontakt:
- Silvia Vannuccini
- Telefonnummer: 055 794 7150
- E-Mail: silvia.vannuccini@unifi.it
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age ≥ 18 years;
- Access to internet and having an email address;
- Diagnosis of endometriosis and/or adenomyosis based on gynecological assessment and imaging evaluation, in accordance with ICD-11 classification (WHO, 2019);
- Seeking care at the Endometriosis Center (Department of Obstetrics and Gynecology at Careggi University Hospital (AOUC));
- Ability to provide informed consent;
- Fluency in written and spoken Italian;
- Under stable pharmacological treatment for at least 3 months;
- For Study 1: ≤12 months from diagnosis;
- For Study 2: >12 months from diagnosis.
Exclusion Criteria:
- Current psychiatric diagnosis assessed with the Structured Clinical Interview for DSM-5 (SCID-5; First et al., 2016);
- Ongoing psychotherapeutic treatment.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Cognitive Behavioral Therapy (CBT)
CBT is a structured intervention targeting dysfunctional thoughts, emotions, and behaviors through psychoeducation, cognitive restructuring, behavioral strategies, and homework. As no standardized CBT protocol for endometriosis exists, this intervention was developed for this study based on CBT principles. In Study 1, CBT comprises 8 biweekly sessions (4 psychoeducational and 4 CBT sessions) targeting physical pain (including central sensitization), mental pain and distress, relational and functional difficulties (including dyspareunia and fatigue), and maladaptive cognitions (catastrophizing, hopelessness, helplessness, and perfectionism). In Study 2, CBT comprises 8 biweekly sessions: 4 core sessions addressing physical pain and dysfunctional thinking, mental pain and distress, relational and functional difficulties (including fatigue), and maladaptive cognitions. Each is followed by a consolidation session to review content and reinforce skills through behavioral exercises. |
Cognitive behavioral therapy (CBT) delivered over 8 biweekly sessions, including psychoeducation, cognitive restructuring, behavioral strategies, and homework assignments. The intervention addresses physical pain, mental pain and psychological distress, relational and functional difficulties, and maladaptive cognitions. The session structure differs between Study 1 and Study 2. |
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Aktiver Komparator: Acceptance and Commitment Therapy (ACT)
ACT promotes psychological flexibility and functioning despite distress through psychoeducation, experiential techniques, values-based action, and practice. As no standardized ACT protocol for endometriosis exists, this intervention was developed for this study based on ACT principles. In Study 1, ACT comprises 8 biweekly sessions (4 psychoeducational, 4 ACT) targeting physical pain (including central sensitization), mental pain and distress, relational and functional difficulties (including dyspareunia and fatigue), and maladaptive cognitions (catastrophizing, hopelessness, helplessness, perfectionism). In Study 2, ACT comprises 8 biweekly sessions: 4 core sessions address physical pain and an open response style, mental pain and distress, relational and functional difficulties (including fatigue), and maladaptive cognitions. Each is followed by a consolidation session reviewing content and introducing open, centered, and engaged response styles through experiential exercises. |
Acceptance and commitment therapy (ACT) delivered over 8 biweekly sessions, including psychoeducation, experiential techniques, values-based action, and behavioral practice. The intervention addresses physical pain, mental pain and psychological distress, relational and functional difficulties, and maladaptive cognitions, while promoting psychological flexibility. The session structure differs between Study 1 and Study 2. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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EQ-5D-5L
Zeitfenster: change from baseline to 6-month follow up
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The primary outcome will be health-related quality of life, assessed using the EQ-5D-5L (health states range from 11111, representing the best health state, to 55555, representing the worst health state). |
change from baseline to 6-month follow up
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Endometriosis Health Profile Questionnaire (EHP-5)
Zeitfenster: change from baseline to 6-month follow up
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Endometriosis Health Profile Questionnaire (EHP-5), with higher scores indicating worse endometriosis-related quality of life. |
change from baseline to 6-month follow up
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Brief Pain Inventory - Short Form (BPI-SF)
Zeitfenster: change from baseline to 6-month follow up
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Brief Pain Inventory - Short Form (BPI-SF), with higher scores indicating greater pain-related disability. |
change from baseline to 6-month follow up
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Psychological Pain Index (PPI)
Zeitfenster: change from baseline to 6-month follow up
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Psychological Pain Index (PPI), with higher scores indicating greater psychological pain. |
change from baseline to 6-month follow up
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Symptom Questionnaire (SQ)
Zeitfenster: change from baseline to 6-month follow up
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Symptom Questionnaire (SQ), with higher scores indicating greater psychological distress. |
change from baseline to 6-month follow up
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Somatic Symptom Disorder - B Criteria Scale (SSD-12)
Zeitfenster: change from baseline to 6-month follow up
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Somatic Symptom Disorder - B Criteria Scale (SSD-12), with higher scores indicating greater somatic symptom burden. |
change from baseline to 6-month follow up
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Pain Catastrophizing Scale (PCS)
Zeitfenster: change from baseline to 6-month follow up
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Pain Catastrophizing Scale (PCS), with higher scores indicating greater pain catastrophizing. |
change from baseline to 6-month follow up
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Chronic Pain Acceptance Questionnaire (CPAQ)
Zeitfenster: change from baseline to 6-month follow up
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Chronic Pain Acceptance Questionnaire (CPAQ), with higher scores indicating greater pain acceptance. |
change from baseline to 6-month follow up
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Multidimensional Psychological Flexibility Inventory (MPFI)
Zeitfenster: change from baseline to 6-month follow up
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Multidimensional Psychological Flexibility Inventory (MPFI), with higher scores indicating greater psychological flexibility/inflexibility. |
change from baseline to 6-month follow up
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Acceptance and Action Questionnaire - II (AAQ-II)
Zeitfenster: change from baseline to 6-month follow up
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Acceptance and Action Questionnaire - II (AAQ-II), with higher scores indicating greater psychological inflexibility. |
change from baseline to 6-month follow up
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Cognitive Fusion Questionnaire (CFQ)
Zeitfenster: change from baseline to 6-month follow up
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Cognitive Fusion Questionnaire (CFQ), with higher scores indicating greater cognitive fusion. |
change from baseline to 6-month follow up
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Cognitive Emotion Regulation Questionnaire (CERQ)
Zeitfenster: change from baseline to 6-month follow up
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Cognitive Emotion Regulation Questionnaire (CERQ), with higher scores indicating greater use of that specific emotion regulation strategy. |
change from baseline to 6-month follow up
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Satisfaction with Life Scale (SWLS)
Zeitfenster: change from baseline to 6-month follow up
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Satisfaction with Life Scale (SWLS), with higher scores indicating greater life satisfaction. |
change from baseline to 6-month follow up
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World Health Organization-Five Well-Being Index (WHO-5)
Zeitfenster: change from baseline to 6-month follow up
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World Health Organization-Five Well-Being Index (WHO-5), with higher scores indicating greater psychological well-being. |
change from baseline to 6-month follow up
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Illness Attitudes Scale (IAS)
Zeitfenster: change from baseline to 6-month follow up
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Illness Attitudes Scale (IAS), with higher scores indicating more dysfunctional illness-related attitudes. |
change from baseline to 6-month follow up
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Brief Illness Perception Questionnaire (BIPQ)
Zeitfenster: change from baseline to 6-month follow up
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Brief Illness Perception Questionnaire (BIPQ), with higher scores indicating more negative illness perceptions. |
change from baseline to 6-month follow up
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Female Sexual Function Index (FSFI)
Zeitfenster: change from baseline to 6-month follow up
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Female Sexual Function Index (FSFI), with higher scores indicating better sexual functioning. |
change from baseline to 6-month follow up
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Chalder Fatigue Scale (CFS)
Zeitfenster: change from baseline to 6-month follow up
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Chalder Fatigue Scale (CFS), with higher scores indicating greater fatigue. |
change from baseline to 6-month follow up
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Fatigue Severity Scale (FSS)
Zeitfenster: change from baseline to 6-month follow up
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Fatigue Severity Scale (FSS), with higher scores indicating greater fatigue severity. |
change from baseline to 6-month follow up
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Beck Hopelessness Scale (BHS)
Zeitfenster: change from baseline to 6-month follow up
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Beck Hopelessness Scale (BHS), with higher scores indicating greater hopelessness. |
change from baseline to 6-month follow up
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Demoralization Scale (Psychiatric Epidemiology Research Interview - PERI)
Zeitfenster: change from baseline to 6-month follow up
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Demoralization Scale (Psychiatric Epidemiology Research Interview - PERI), with higher scores indicating greater demoralization. |
change from baseline to 6-month follow up
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Frost Multidimensional Perfectionism Scale (FMPS)
Zeitfenster: change from baseline to 6-month follow up
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Frost Multidimensional Perfectionism Scale (FMPS), with higher scores indicating higher levels of perfectionism. |
change from baseline to 6-month follow up
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Somatosensory Amplification Scale (SSAS)
Zeitfenster: change from baseline to 6-month follow up
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Somatosensory Amplification Scale (SSAS), with higher scores indicating greater somatic amplification. |
change from baseline to 6-month follow up
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Eating Disorder Inventory (EDI)
Zeitfenster: change from baseline to 6-month follow up
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Eating Disorder Inventory (EDI), with higher scores indicating greater eating-related psychopathology. |
change from baseline to 6-month follow up
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Childhood Trauma Questionnaire - Short Form (CTQ-SF)
Zeitfenster: change from baseline to 6-month follow up
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Childhood Trauma Questionnaire - Short Form (CTQ-SF), with higher scores indicating greater exposure to childhood trauma. |
change from baseline to 6-month follow up
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Social Readjustment Rating Scale (SRRS)
Zeitfenster: change from baseline to 6-month follow up
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Social Readjustment Rating Scale (SRRS), with higher scores indicating greater exposure to stressful life events. |
change from baseline to 6-month follow up
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Geller S, Levy S, Ashkeloni S, Roeh B, Sbiet E, Avitsur R. Predictors of Psychological Distress in Women with Endometriosis: The Role of Multimorbidity, Body Image, and Self-Criticism. Int J Environ Res Public Health. 2021 Mar 26;18(7):3453. doi: 10.3390/ijerph18073453.
- Donatti L, Malvezzi H, Azevedo BC, Baracat EC, Podgaec S. Cognitive Behavioral Therapy in Endometriosis, Psychological Based Intervention: A Systematic Review. Rev Bras Ginecol Obstet. 2022 Mar;44(3):295-303. doi: 10.1055/s-0042-1742406. Epub 2022 May 16.
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- Del Pino-Sedeno T, Cabrera-Maroto M, Abrante-Luis A, Gonzalez-Hernandez Y, Ortiz Herrera MC. Effectiveness of psychological interventions in endometriosis: a systematic review with meta-analysis. Front Psychol. 2024 Oct 28;15:1457842. doi: 10.3389/fpsyg.2024.1457842. eCollection 2024.
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- First, M. B., Williams, J. B. W., Karg, R. S., & Spitzer, R. L. (2016). Structured clinical interview for DSM-5 disorders, clinician version (SCID-5-CV). American Psychiatric Association Publishing.
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Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Uteruserkrankungen
- Genitalerkrankungen, weiblich
- Adenomyose
- Endometriose
- Verhaltenstherapie
- Psychotherapie
- Verhaltensdisziplinen und Aktivitäten
- Kognitive Verhaltenstherapie
- Akzeptanz und Verpflichtungstherapie
Andere Studien-ID-Nummern
- T-ENDO
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Data will be shared upon request to the PI. Data can be shared as aggregated, anonymized information.
IPD-Sharing-Zeitrahmen
From 01.01.2030 to 31.12.2030
IPD-Sharing-Zugriffskriterien
Researchers will be able to access.
Art der unterstützenden IPD-Freigabeinformationen
- ICF
- CSR
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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