Gaillard, Martin http://orcid.org/0000-0003-1539-2118
Lainas, Panagiotis
Agostini, Hélène
Dagher, Ibrahim
Tranchart, Hadrien
Funding for this research was provided by:
Direction Générale de l’offre de Soins (AOM15323)
Article History
Received: 12 April 2021
Accepted: 20 October 2021
First Online: 15 November 2021
Declarations
:
: The study is being performed in accordance with the 2013 Fortaleza, Brazil, Revision of the Declaration of Helsinki, the French Public Health Code Statement on Human Experimentation, the French National Agency for the Safety of Therapeutic Goods (Agence Nationale pour la Sécurité du Médicament et des produits de santé), the French (Commission Nationale de l'Informatique et des Libertés) and European (General Data Protection Regulation) laws governing data protection regulations.Ethics approval for the trial was obtained from an independent ethics committee (Comité de Protection des Personnes Ile-de-France VII, approval number 16-029). The study has received local governance approvals at each of the participating sites. Protocol amendments are submitted and approved by the ethics committee prior to implementation. Written informed consent is obtained from all participants in the study.
: Consent for publication is not applicable since there are no identifying images or other personal or clinical details of participants presented. A model participant information sheet and consent form are provided in Additional file InternalRef removed.
: The authors declare that they have no competing interests.