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Article History

Received: 13 March 2026

Accepted: 20 March 2026

First Online: 27 March 2026

Declarations

:

: Ethical approval for the trial was granted by the Comité de Protection des Personnes (CPP) - Est II. The site investigator will give the family a first information about the research and hand out patient information and consent forms. Informed consent and assent will be collected from parents, children and adolescents, before starting any trial-specific procedure through an online consent signature. Participants will be advised that research is entirely voluntary and that they can withdraw their participation at any time. The centre will try to obtain consent from both parents. In case of consent from one parent only, this will be justified by the centre.

: Not applicable.

: 22nd of December 2025; version n°4.

: PO / General Director, Renan TARGHETTA, Research Director, La Colombière Hospital – Pavillon 32, 39, Avenue Charles Flahault − 34295 Montpellier Cedex 5.

: The sponsor is responsible for ensuring compliance with regulations and the GDPR, the administrative and financial management of the study, the quality of the trial, the selection of investigators, and the study sites.

: The coordination of the study will be carried out by the Montpellier team, specifically by Prof. D. Purper-Ouakil.

: RESEARCH INVOLVING THE HUMAN PERSON (Jardé Law framework): Interventional research that involves only minimal risks and constraints, the list of which is set by order of the Minister in charge of health following an opinion from the Director General of the ANSM (category 2) - Order of 12 April 2018 setting the list of research mentioned in 2° of Article L.1121-1 of the CSP.

: DPO declares speaker honoraria from Medice and Teva, travel and accommodation fees from Medice and HAC Pharma and one participation in a board meeting with Biocodex without honoraria.The other authors declare that they have no competing interests.