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Article History

Received: 19 July 2024

Accepted: 18 September 2024

First Online: 23 October 2024

Declarations

:

: This study follows the guidelines established in the French methodology of reference for studies in medical health (MR-001). Automated monitoring of health-related data is in line with the European Guidelines regarding the processing of personal data for scientific research purposes as established by the European Data Protection Board (April 27th, 2016). Clinical, neuropsychological, and socio-demographic data will be anonymized, and each participant will be identified with a code. Imaging data will be anonymized according to the guidelines provided by the DICOM standard committee (Clinical Trials De-Identification Profiles) and transmitted to the investigating team.Explicit and informed consent from the participants and their legal representatives will be collected after they have been informed of the study objectives, its duration and procedure, as well as the potential risks and benefits of taking part in the research. Information notice will be given to both the participants and their legal representatives. Consent forms will be signed and dated by all involved parties, including a designated investigator. The medical procedures used in this study follow the guidelines of the Helsinki Declaration, as well as those of the law n°2012 − 300 (5th of march, 2012) and its application decree n° 2016 − 1537 (16th November 2016). Patients can retract their consent at any moment and can always exert their right to access and rectify their data. The promoter of the study will keep the participants informed of the results of the study at the end of the research.An ID-RCB registration number has been requested from the <i>Agence Nationale de Sécurité du Médicament et des Produits de Santé</i> (ANSM): IDRCB number 2019-A00366-51. This study was approved by the <i>Comité de Protection des Personnes</i> (Ethics Committee) on 05 January 2021 (RI-HPS), after being registered as a clinical trial on clinicaltrials.gov (trial number: NCT0485274, registered on 21/04/2021).

: Not applicable.

: The authors declare no competing interests.