Bouzat, Pierre
Gauss, Tobias
Adolle, Anais
Roustit, Mathieu
Bosson, Jean-Luc
Tazarourte, Karim
Article History
Received: 24 February 2025
Accepted: 19 August 2025
First Online: 29 September 2025
Declarations
:
: Protocol was approved by the Institutional Review Board Ile de France V, on July 2, 2017, and authorized by the French competent authority (Agence Nationale pour la Sécurité du Médicament, ANSM) on June 17, 2019 (documents provided as additional files). The study is carried out following Good Clinical Practices, the principles of the Declaration of Helsinki, and European legislation. Written, informed consent to participate will be obtained from all participants.
: Although it is not anticipated, owing to the trial design, publication of any personal information about a patient will require her/his consent.
: PB, TG, KT, MR, JLB, and AA have no conflict of interest to declare.