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Authors
Duclos, Gary
Resseguier, Noémie
Arbelot, Charlotte
Pastene, Bruno
Zieleskiewicz, Laurent
Leone, Marc
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Funding
Funding for this research was provided by:
Assistance Publique Hopitaux de Marseille
Fondation pour l’avenir (AP-FPB-22-002)
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Article History
Received: 5 April 2026
Accepted: 8 June 2026
First Online: 17 June 2026
Declarations
Ethics approval and consent to participate: The study was approved by the Comité de Protection des Personnes Nord-Ouest II on 13 January 2021 (reference number: 20.11.27.37320 and authorized by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) on 5 March 2021 (reference number: MEDAECNAT-2020-11-00050_2020-004812-81). The trial is registered at ClinicalTrials.gov (NCT04833816) and in EudraCT (2020-004812-81). Written informed consent was obtained from all participants before inclusion. The trial is conducted in accordance with applicable French regulations for category 1 interventional research involving medicinal products, the Declaration of Helsinki, and Good Clinical Practice.
Competing interests: The authors declare no competing interests.
