The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature
Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Inpegsomatropin Injection Versus Givopegsomatropin Solution Injection in the Treatment of Short Stature in Children With Turner Syndrome.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Xiaoping Luo
- Telefonnummer: 15671671188
- E-mail: xpluo@tjh.tjmu.edu.cn
Studiesteder
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-
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Anyang, Kina
- Rekruttering
- Anyang Maternal and Child Health Hospital
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Kontakt:
- Huiping An
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Beijing, Kina
- Rekruttering
- Peking University First Hospital
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Kontakt:
- Yanling Yang
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Beijing, Kina
- Rekruttering
- Beijing Children's hospital, Capital Medical University
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Kontakt:
- Di Wu
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Beijing, Kina
- Rekruttering
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
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Kontakt:
- Hui Pan
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Beijing, Kina
- Rekruttering
- Capital Institute of Pediatrics, Capital Medical University
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Kontakt:
- Bingyan Cao
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Changsha, Kina
- Rekruttering
- The Second Xiangya Hospital Of Central South University
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Kontakt:
- Xingxing Zhang
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Chengdu, Kina
- Rekruttering
- Chengdu Women's and Children's Central Hospital
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Kontakt:
- Xinran Cheng
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Chongqing, Kina
- Rekruttering
- Children's Hospital of Chongqing Medical University
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Kontakt:
- Min Zhu
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Dalian, Kina
- Rekruttering
- The First Affiliated Hospital of Dalian Medical University
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Kontakt:
- Luyi Ma
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Guangzhou, Kina
- Rekruttering
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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Kontakt:
- Liyang Liang
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Guangzhou, Kina
- Rekruttering
- The First Affiliated Hospital of Sun Yat-Sen University
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Kontakt:
- Qiuli Chen
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Guangzhou, Kina
- Rekruttering
- The third affiliated hospital of Sun Yat-Sen University
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Kontakt:
- Shunye Zhu
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Guangzhou, Kina
- Ikke rekrutterer endnu
- Guangdong Provincial Maternal and Child Health Hospital
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Kontakt:
- Shu Liu
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Hangzhou, Kina
- Rekruttering
- The First Affiliated Hospital, Zhejiang University School of Medicine
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Kontakt:
- Chunlin Wang
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Hangzhou, Kina
- Rekruttering
- Zhejiang Provincial Hospital of Traditional Chinese Medicine
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Kontakt:
- Lan Li
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Hebei, Kina
- Rekruttering
- The First Affiliated Hospital of Hebei North University
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Kontakt:
- Zhengrong Xu
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Henan, Kina
- Rekruttering
- The First Affiliated Hospital of Henan University of Science and Technology
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Kontakt:
- Dan Lou
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Huzhou, Kina
- Rekruttering
- Huzhou Central Hospital
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Kontakt:
- Wei Qiu
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Jiangxi, Kina
- Rekruttering
- Jiangxi Provincial Children's Hospital
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Kontakt:
- Yu Yang
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Jilin City, Kina
- Rekruttering
- The First Hospital of Jilin University
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Kontakt:
- Yining Zhang
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Jinan, Kina
- Rekruttering
- Shandong Provincial Hospital
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Kontakt:
- Yan Sun
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Jining, Kina
- Rekruttering
- Affiliated Hospital of Jining Medical University
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Kontakt:
- Mei Zhang
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Kunming, Kina
- Rekruttering
- Kunming Children's Hospital
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Kontakt:
- Na Tao
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Lanzhou, Kina
- Rekruttering
- Gansu Provincial People's Hospital
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Kontakt:
- Juxiang Liu
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Nanning, Kina
- Rekruttering
- The Second Affiliated Hospital of Guangxi Medical University
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Kontakt:
- Xin Fan
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Pingxiang, Kina
- Rekruttering
- Pingxiang People's Hospital
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Kontakt:
- Guangping Qin
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Qilu, Kina
- Rekruttering
- Qilu Hospital of Shandong University
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Kontakt:
- Aihua Cao
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Shanghai, Kina
- Rekruttering
- Shanghai Children's Hospital
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Kontakt:
- Fei Wang
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Shanghai, Kina
- Rekruttering
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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Kontakt:
- Wenjuan Qiu
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Shanghai, Kina
- Rekruttering
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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Kontakt:
- Wenli Lu
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Shanghai, Kina
- Rekruttering
- Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
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Kontakt:
- Yu Ding
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Shanxi, Kina
- Rekruttering
- The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
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Kontakt:
- Haibo Lin
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Shaoxing, Kina
- Rekruttering
- Shaoxing people's Hospital
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Kontakt:
- Dihua Huang
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Shenyang, Kina
- Rekruttering
- Shengjing Hospital of China Medical University
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Kontakt:
- Ying Xin
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Shenzhen, Kina
- Rekruttering
- Shenzhen Children's Hospital
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Kontakt:
- Zhe Su
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Sichuan, Kina
- Rekruttering
- West China Second University Hospital, Sichuan University
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Kontakt:
- Jin Wu
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Suzhou, Kina
- Rekruttering
- Children's Hospital Of Soochow University
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Kontakt:
- Fengyun Wang
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Taizhou, Kina
- Rekruttering
- Taizhou People's Hospital
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Kontakt:
- Shufang Yang
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Taizhou, Kina
- Rekruttering
- Taizhou First People's Hospital
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Kontakt:
- Xiaoming Ying
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Tangshan, Kina
- Rekruttering
- Tangshan Maternal and Child Health Hospital
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Kontakt:
- Lanying Wang
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Wenzhou, Kina
- Rekruttering
- The First Affiliated Hospital of Wenzhou Medical University
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Kontakt:
- Hong Zhu
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Wuhan, Kina
- Rekruttering
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Kontakt:
- Xiaoping Luo
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Wuhan, Kina
- Rekruttering
- Wuhan Children's Hospital
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Kontakt:
- Hui Yao
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Wuxi, Kina
- Rekruttering
- Affiliated Hospital of Jiangnan University
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Kontakt:
- Yaping Ma
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Xi'an, Kina
- Rekruttering
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Kontakt:
- Erdi Xu
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Xiamen, Kina
- Ikke rekrutterer endnu
- Xiamen Maternal and Child Health Hospital
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Kontakt:
- Xiaoqing Yang
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Xiangyang, Kina
- Rekruttering
- Xiangyang First People's Hospital
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Kontakt:
- Xi Yang
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Xinjiang, Kina
- Rekruttering
- The First Affiliated Hospital of Xinjiang Medical University
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Kontakt:
- Mirigul Maimaiti
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Yibin, Kina
- Rekruttering
- Yibin Second People's Hospital
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Kontakt:
- Lan Yao
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Zhengzhou, Kina
- Rekruttering
- Henan Children's Hospital Zhengzhou Children's Hospital
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Kontakt:
- Haiyan Wei
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Zibo, Kina
- Rekruttering
- Zibo Central Hospital
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Kontakt:
- Xiaodong Zhao
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Prepubertal girls at Tanner stage I, with age ≥ 2 years and < 12 years at the time of informed consent signature.
- With clinical manifestations of Turner syndrome and a confirmed diagnosis of Turner syndrome based on peripheral blood karyotype analysis (karyotype analysis of at least 30 metaphase cells).
- At screening, bone age is delayed relative to chronological age or advanced by no more than 1 year (i.e., bone age - chronological age ≤ 1 year).
- At screening, height is below -2 standard deviations (-2SD) of the mean for age and gender; height reference is shown in Appendix 1.
- No prior systematic pharmacological growth-promoting treatment (continuous use for ≥ 1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc.
- Thyroid hormone replacement therapy (if applicable) received prior to randomization should be maintained on a stable regimen for at least 4 weeks.
- The legal guardian understands and signs the informed consent form; participants aged ≥ 8 years shall also sign the informed consent form. For participants aged under 8 years who are capable of expressing assent, their assent shall be clearly documented.
Exclusion Criteria:
- Subjects with closed epiphyses.
- Patients with Turner syndrome carrying Y chromosome or Y-chromosome-derived fragments and without gonadectomy.
- Other types of growth and development abnormalities, including but not limited to growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, and growth retardation caused by malnutrition.
- Participation in any other clinical trial within 3 months prior to screening with pharmacological or non-pharmacological intervention received.
- Inhaled glucocorticoids used continuously for more than 2 weeks, or oral/intravenous glucocorticoids used continuously for more than 1 week within 3 months prior to screening.
- Receiving other treatments that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, etc.
- Abnormal liver and renal function at screening (ALT > 2 times the upper limit of normal; Cr > upper limit of normal).
- Subjects with abnormal glucose metabolism, including: a. Diagnosed diabetes mellitus; b. Fasting blood glucose ≥ 6.1 mmol/L on two consecutive measurements; c. Glycated hemoglobin (HbA1c) ≥ 6.5%; d. Impaired glucose tolerance judged by the investigator as unsuitable for participation in this study.
- Presence of chronic infectious diseases judged by the investigator to interfere with study participation, such as chronic hepatitis B.
- Subjects with systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases (e.g., aortic dissection, uncontrolled hypertension), psychiatric and psychological disorders.
- Subjects with severe congenital skeletal dysplasia; or those with scoliosis > 20°, significant kyphosis, claudication, or a prior diagnosis of slipped capital femoral epiphysis.
- Subjects with a prior history of intracranial hypertension.
- Subjects with a history of malignant tumor or current active malignant tumor, including intracranial tumors.
- Known hypersensitivity to growth hormone or its excipients.
- Subjects with celiac disease who have not maintained a gluten-free diet within 12 months prior to screening.
- Any other conditions deemed inappropriate for enrollment in this clinical trial by the investigator.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Inpegsomatropin Injection Group
|
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
|
|
Aktiv komparator: Givopegsomatropin Solution Injection Group
|
Givopegsomatropin Solution Injection, 200 μg/kg/week, s.c., once weekly, for 52 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Væksthastighed (HV, CM/år).
Tidsramme: Uge 52
|
Uge 52
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Ændring i højde standardafvigelsesscore fra baseline (△ ht SDS)
Tidsramme: Fra baseline til alle opfølgende tidspunkter i uge 52
|
Fra baseline til alle opfølgende tidspunkter i uge 52
|
|
Ændring i insulinlignende vækstfaktor 1 Standardafvigelsesscore fra baseline (△ IGF-1 SDS)
Tidsramme: Fra baseline til alle opfølgende tidspunkter i uge 52
|
Fra baseline til alle opfølgende tidspunkter i uge 52
|
|
Change in height velocity from baseline (△HV)
Tidsramme: From baseline to all follow-up time points at Week 52
|
From baseline to all follow-up time points at Week 52
|
|
Ratio of change in bone age from baseline to change in chronological age from baseline (△BA/△CA)
Tidsramme: Week 52
|
Week 52
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Ledende efterforsker: Xiaoping Luo, Tongji Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Sygdomme i det endokrine system
- Hjerte-kar-sygdomme
- Mandlige urogenitale sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Hjertesygdomme
- Genetiske sygdomme, medfødte
- Gonadale lidelser
- Medfødte abnormiteter
- Kardiovaskulære abnormiteter
- Hjertefejl, medfødt
- Forstyrrelser i seksuel udvikling
- Urogenitale abnormiteter
- Kønskromosomforstyrrelser
- Kromosomlidelser
- Kønskromosomforstyrrelser i kønsudvikling
- Gonadal dysgenese
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Turners syndrom
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- PEGPESEN-4-2-004
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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