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Article History

Received: 1 October 2025

Accepted: 6 March 2026

First Online: 13 March 2026

Declarations

:

: This study was approved by the French national ethics committee (Comité de protection des personnes Sud-Est I) on March 24th 2024. Notification of the Committee’s approval was forwarded to the National Medicines Safety Agency (ANSM) by the sponsor (Grenoble Alpes University Hospital, Delegation for Clinical Research and Innovation). Moreover, the study was registered on Clinical-Trials.gov (NCT06424847) on 16/05/2024. The protocol was amended on February 13th 2025 in order to reduce the number of questionnaires, and add precisions regarding inclusion criteria. The current protocol is version 2 (13/02/2025). All potential major changes to the protocol will be reported to the relevant regulatory authorities All participants that volunteer will be asked to sign a written informed consent prior to program participation with a study investigator.The sponsor and investigators commit to conducting the clinical investigation in compliance with French law (Law n°2012-300, March 5, 2012), European Regulation n°2017/745, ISO Standard 14155:2020, and the Declaration of Helsinki. Investigators will ensure proper consent collection and adverse event reporting. The sponsor will be in charge of auditing and monitoring. Data will be processed in compliance with French data protection laws (Law no. 78-17 of 1978, amended by law no. 2018-493) and the EU GDPR (Regulation 2016/679). This investigation complies with the Reference Methodology” (MR-001) per article 54(5) of the amended 1978 law and has authorization from the National Commission for Information Technology and Civil Liberties (CNIL). The sponsor of the study has committed to adhering to this methodology and has obtained dedicated insurance coverage.

: Not applicable.

: The authors declare no competing interests.