Document is current

Article History

Received: 19 November 2025

Accepted: 1 June 2026

First Online: 13 June 2026

Declarations

:

: This study includes an intervention specific to the research, thus it falls within the scope of research involving the human person. It involves only minimal risks and constraints. It was approved by Ethical Review Board: Comité de Protection des Personnes Sud Méditerranée ID-RCB 2024-A00754-43 on 02/06/2024. Informed consent will be obtained by investigators authorized in the study and listed on the delegation of tasks log. Only competent adult participants capable of making decisions for themselves will be included. Consent will be collected in person during a consultation. No additional consent provisions for ancillary studies or use of biological specimens are applicable.

: Manuscript does not contain any individual person’s data in any form. Trial results will be published in scientific journals or included in the final study report. Authorship eligibility will follow international guidelines (ICMJE). Members of the Clinical Investigation Center (CIC1431) involved in protocol design, data analysis, and manuscript preparation will be included as authors according to standard authorship criteria. Participants may request access to study results.

: During the preparation of this work, the authors used ChatGPT solely to improve the readability of the manuscript, as English is not their native language. After using this tool, the authors carefully reviewed and edited the content and take full responsibility for the final version of the manuscript.

: This is a single-center study with a clear responsibility matrix defining communication roles. The Principal Investigator (PI) requests the modification submission, which is prepared and followed up by the project manager. After positive feedback from the Ethics Committee (CPP) is received by the Research Department (DRCI), the PI, project manager, and all relevant parties are promptly informed.

: The Sponsor is the data controller and commits to collecting only data strictly necessary for the research objectives. Data are pseudonymized using a unique code, excluding direct identifiers. Only the investigator and authorized staff can link codes to participant identities. A responsibility policy ensures data security and confidentiality, compliant with applicable regulations (including MR001 and GDPR). Participants are informed about data use, their rights, and data retention periods. Data collection sources are the participants themselves, their legal representatives, and involved professionals.

: The authors declare no competing interests.