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Article History

Received: 9 June 2024

Accepted: 6 May 2025

First Online: 15 May 2025

Declarations

:

: The project has been approved by a Research Ethics Committee, committee for the protection of persons (CPP) Ile de France I. It was designed in line with the Declaration of Helsinki and registered at , NCT05116514. All changes to the protocol will be submitted for ethical approval and then forwarded to investigators and participants. Additionally, during the funding process, the protocol has undergone independent peer review.Participants are informed by investigators about the trial and about the voluntary nature of their participation with both written and verbal communications. Participants are only randomized following the provision of informed consent. Persons in mandatory care, often in inpatient unit, can consent to the study if their clinical condition allows it according to medical and participant evaluation. For minors, their consent and the consent of the two legal guardians are necessary. The choice of the treatment according to the randomization is explained to the participants as well as their families.If an ancillary or post-trial study is developed, it will be submitted for ethical approval.

: Participants who give their informed consent for this study are informed of the use of their data for publication purposes. Any written or oral communication of the results of the research must receive the prior agreement of the coordinating investigator and the sponsor.

: The authors declare no competing interests.