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Authors
Lejeune, Thierry https://orcid.org/0000-0001-5741-7753
Nuic, Dijana
Dehem, Stéphanie https://orcid.org/0000-0002-5487-2344
Previnaire, Jean-Gabriel
Cuenot, Céline
Debugne, Thierry
Kaps, Jerome
Paul, Bérénice
Pean, Vincent
Perez, Sergi Sanz
Juhel, Fanny
Tatsidou, Soultana
Kerdraon, Jacques
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Article History
Received: 9 September 2024
Accepted: 3 April 2025
First Online: 12 April 2025
Declarations
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: This study was performed in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines and was approved by the local ethics committee (CPP Ouest-IV, CE Hospitalo-Facultaire Saint Luc, and CNER, registered under ID RCB: 2020-A02437-32, B403202000079, and 202010/03, respectively). It was authorized by the French, Belgium and Luxembourg competent authorities (ANSM, AFMPS, and CNER). The study was promoted by the Wandercraft (CIP002) and registered in a public trial registry (Trial Registration: NCT04694001 ClinicalTrials.gov). All participants had agreed to participate and provided written informed consent.
: Not applicable.
: Prof Thierry LEJEUNE, MD, PhD*; Stéphanie DEHEM, PhD; Jean-Gabriel PREVINAIRE, MD; Céline CUENOT, Pt; Jerome KAPS, PT; Bérénice PAUL, PT; Sergi SANZ PEREZ, PT, MSc; Fanny JUHEL, MD; Soultana TATSIDOU, MD, Jacques KERDRAON, MD have no conflict to declare. Vincent PÉAN, PhD received compensation by Wandercraft to perform the independent statistical analysis of the data. Dijana NUIC, PhD is employed by Wandercraft. Thierry DEBUGNE, MD is a speaker for Coloplast-AbbVie.
