Document is current

Article History

Received: 23 May 2024

Accepted: 17 September 2024

First Online: 3 October 2024

Declarations

:

: The protocol received approval from the French ethics committee “Comité de protection des personnes Ile de France VII, France” (n°-2022-A01874-39 on 2nd December 2022) and of the French "Commission Nationale de l'Informatique et des Libertés" (Data Protection Authority) for centralized monitoring (on 6th June 2023). The trial is conducted in compliance with French law no. 2012-300 of 12 March 2012 relative to the research involving the human person and following Good Clinical Practice (I.C.H. E6(R2)), the Public Health Code of Ethics, and the Helsinki Declaration (Ethical Principles for Medical Research involving Human Subjects, Tokyo 2004) and other requirements as appropriate. Free and informed consent will be requested before each inclusion.The study is registered on an open access website (ClinicalTrials.gov) under the number 49RC22_0240.

: Not applicable - no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request.

: The authors declare that they have no competing interests.