Een proef met de werkzaamheid en veiligheid van SEP-363856 bij acuut psychotische deelnemers met schizofrenie
Een fase 3, gerandomiseerde, dubbelblinde, parallelle groep, placebo-gecontroleerde, multicenter-studie om de werkzaamheid en veiligheid van SEP-363856 te evalueren bij acuut psychotische deelnemers met schizofrenie met schizofrenie
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Studie Overzicht
Toestand
Toestand
Conditie
Conditie
Interventie / Behandeling
Interventie / Behandeling
Gedetailleerde beschrijving
A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia
Studietype
Studietype
Inschrijving (Werkelijk)
Inschrijving
Fase
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Wakayama, Japan, 641-8510
- Wakayama Medical University Hospital
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Aichi-ken
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Konan-shi, Aichi-ken, Japan, 483-8248
- Hotei Hospital
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Toyoake-shi, Aichi-ken, Japan, 470-1168
- Seishinkai Okehazama Hospital
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Aomori
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Hachinohe-shi, Aomori, Japan, 039-1104
- Seijinkai Seinan Hospital
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Chiba
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Chiba, Chiba, Japan, 266-0007
- National Hospital Organization Shimofusa Psychiatric Medical Center
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Ichikawa-shi, Chiba, Japan, 272-8516
- National Kohnodai Medical Center
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Fukuoka
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Fukuoka, Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
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Fukuoka, Fukuoka, Japan, 819-0037
- Kuramitsu Hospital
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Kokuraminami-ku, Kitakyushu-shi, Fukuoka, Japan, 802-8533
- National Hospital Organization Kokura Medical Center Site
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Omuta-shi, Fukuoka, Japan, 836-0004
- Shiranui Hospital
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Fukushima
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Kōriyama, Fukushima, Japan, 963-0198
- Social Medical Corporation Asaka Hospital
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Hiroshima
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Kure, Hiroshima, Japan, 737-0111
- Hayakawa Clinic
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Kure-shi, Hiroshima, Japan, 737-0023
- NHO Kure Medical Center
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Hokkaido
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Nayoro-shi, Hokkaido, Japan, 096-8511
- Nayoro City General Hospital
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Obihiro, Hokkaido, Japan, 080-0024
- Obihiro Kosei Hospital
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Sapporo, Hokkaido, Japan, 002-8029
- Goryokai Medical Corporation Hospital
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Iwate
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Shiwa-gun, Iwate, Japan, 028-3695
- Iwate Medical University Hospital
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Kanagawa
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Hadano-shi, Kanagawa, Japan, 257-0003
- Hatano Kousei Hospital
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Hadano-shi, Kanagawa, Japan, 259-1304
- Tanzawa Hospital
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Hiratsuka-shi, Kanagawa, Japan, 259-1205
- Fujimidai Hospital Site
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Yokohama, Kanagawa, Japan, 234-0051
- Yokohama Hino Hospital
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Kumamoto
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Kumamoto, Kumamoto, Japan, 861-8002
- Yuge Hospital
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Miyazaki
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Miyakonojo-shi, Miyazaki, Japan, 885-0093
- Miyakonojo Shinsei Hospital
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Osaka
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Moriguchi-shi, Osaka, Japan, 570-8507
- Kansai Medical University Medical Center
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Neyagawa, Osaka, Japan, 572-0854
- Neyagawa Sanatorium
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Saga-ken
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Kanzaki-gun, Saga-ken, Japan, 842-0192
- National Hospital Organization Hizen Psychiatric Medical Center Site
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Karatsu-shi, Saga-ken, Japan, 847-0031
- Rainbow and Sea Hospital
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Tosu-shi, Saga-ken, Japan, 841-0081
- Inuo Hospital
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Shiga
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Ōtsu, Shiga, Japan, 520-2192
- Shiga University of Medical Science Hospital
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Tochigi
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Shimotsuga-gun, Tochigi, Japan, 321-0293
- Dokkyo Medical University Hospital
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Shimotsuke-Shi, Tochigi, Japan, 329-0498
- Jichi Medical University Hospital
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Utsunomiya, Tochigi, Japan, 329-1104
- Tochigi Prefectural Okamotodai Hospital
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Tokyo
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Kodaira-shi, Tokyo, Japan, 187-8551
- National Center of Neurology and Psychiatry
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Machida-shi, Tokyo, Japan, 194-0005
- Asuka Hospital
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Setagaya-ku, Tokyo, Japan, 157-8577
- Showa Medical University Karasuyama Hospital
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Toyama
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Toyama, Toyama, Japan, 930-8550
- Toyama Prefectural Center Hospital
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Yamagata
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Sakata-shi, Yamagata, Japan, 998-0074
- Sanyo Hospital
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Yamagata, Yamagata, Japan, 990-0045
- Yamagata Sakuracho Hospital Site
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Arkansas
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Bentonville, Arkansas, Verenigde Staten, 72712
- Pillar Clinical Research LLC - Bentonville Site
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Little Rock, Arkansas, Verenigde Staten, 72204
- Pillar Clinical Research (Little Rock AR) Site
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Little Rock, Arkansas, Verenigde Staten, 72211
- Woodland International Research Group Site
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Rogers, Arkansas, Verenigde Staten, 72758
- Woodland Research Northwest Site
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California
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Bellflower, California, Verenigde Staten, 90706
- Clinical Innovations, Inc. dba CITrials (Bellflower)
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Culver City, California, Verenigde Staten, 90230
- ProScience Research Group Site
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Garden Grove, California, Verenigde Staten, 92845
- CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site
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Lemon Grove, California, Verenigde Staten, 91945
- Synergy San Diego Site
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Montclair, California, Verenigde Staten, 91763
- Catalina Research Institute Site
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Riverside, California, Verenigde Staten, 92506
- Clinical Innovations Inc. DBA CITrials (Riverside)
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Riverside, California, Verenigde Staten, 92506
- Richmond Behavioral Associates LLC
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San Diego, California, Verenigde Staten, 92123
- CNRI - San Diego LLC Site
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Sherman Oaks, California, Verenigde Staten, 91403
- Schuster Medical Research Institute
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Torrance, California, Verenigde Staten, 90504
- CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)
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Florida
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Hialeah, Florida, Verenigde Staten, 33016
- Galiz Research Site
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Hollywood, Florida, Verenigde Staten, 33021
- Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site
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Hollywood, Florida, Verenigde Staten, 33024
- Cenexel RCA (Research Centers of America) Site
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Miami, Florida, Verenigde Staten, 33122
- Premier Clinical Research Institute
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Miami, Florida, Verenigde Staten, 33155
- D & H National Research Centers NC
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Miami Lakes, Florida, Verenigde Staten, 33016
- Innovative Clinical Research, Inc. Site
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West Palm Beach, Florida, Verenigde Staten, 33407
- Health Synergy Clinical Research LLC Site
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30328
- Synexus Clinical Research US Inc - Atlanta
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Atlanta, Georgia, Verenigde Staten, 30331
- CenExel ACMR (Atlanta Center for Medical Research, LLC) Site
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Decatur, Georgia, Verenigde Staten, 30030
- CenExel IRA (CenExcel iResearch, LLC) Site
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Peachtree Corners, Georgia, Verenigde Staten, 30071
- Accelerated Clinical Trials in Peachtree Corners GA Site
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Illinois
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Chicago, Illinois, Verenigde Staten, 60640
- Uptown Research Institute
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Chicago, Illinois, Verenigde Staten, 60641
- Pillar Clinical Research LLC (Chicago)
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70127
- Eastern Clinical Research Associates
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Maryland
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Gaithersburg, Maryland, Verenigde Staten, 20877
- Cenexel CBH (CBH Health)
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New Jersey
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Marlton, New Jersey, Verenigde Staten, 20877
- Hassman Research Institute, LLC
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Ohio
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North Canton, Ohio, Verenigde Staten, 44720
- Neuro-Behavioral Clinical Research Site
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Texas
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Austin, Texas, Verenigde Staten, 78754
- Community Clinical Research Inc
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DeSoto, Texas, Verenigde Staten, 75115
- InSite Clinical Research
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Houston, Texas, Verenigde Staten, 77043
- HD Research - Memorial Hermann Surgery Center Memorial Village
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Richardson, Texas, Verenigde Staten, 75080
- Pillar Clinical Research LLC (Richardson, TX) Site
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Deelname Criteria
Geschiktheidscriteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Key Inclusion Criteria:
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Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
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Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).
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Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening
- The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
- If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
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Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:
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Participant must have a PANSS total score ≥ 80
AND
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Participant must have a CGI-S score ≥ 4.
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Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.
Key Exclusion Criteria:
- Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.
- Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
- Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.
- Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Aantal wapens
Wapens en interventies
Deelnemersgroep / ArmDeelnemersgroep / Arm |
Interventie / BehandelingInterventie / Behandeling |
|---|---|
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Placebo-vergelijker: Placebo
Placebo |
tablet |
|
Experimenteel: SEP-363856 75 mg
SEP-363856 75 mg/day |
tablet |
|
Experimenteel: SEP-363856 100 mg
SEP-363856 100 mg/day |
tablet |
Wat meet het onderzoek?
Primaire uitkomstmaten
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
Tijdsspanne: Baseline to Week 6
|
To evaluate the efficacy of SEP-363856 (75 and 100 mg/day) compared with placebo in acutely psychotic participants with schizophrenia. PANSS total - 30-210 Higher score is indicative of greater symptomatology |
Baseline to Week 6
|
Secundaire uitkomstmaten
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Clinical Global Impression-Severity (CGI-S)
Tijdsspanne: Baseline to Week 6
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Change from baseline in CGI-S score at Week 6. CGI-S is 0-7 with higher score is indicative of greater symptomatology |
Baseline to Week 6
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Medewerkers en onderzoekers
Sponsor
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Studie start
Primaire voltooiing (Geschat)
Primaire voltooiing
Studie voltooiing (Geschat)
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Eerst geplaatst
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update geplaatst
Laatste update ingediend die voldeed aan QC-criteria
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
Andere studie-ID-nummers
- 382-201-00035
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Anonymized Individual participant data (IPD) that underlie the result of this study will be shared with researchers to achieve aims pre-specified in a methodology sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD-tijdsbestek voor delen
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD-toegangscriteria voor delen
Otsuka will share data on the Vivli data sharing platform which can be found here: http://vivli.org/ourmember/Otsuka/
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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