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Article History

Received: 4 May 2022

Accepted: 27 October 2022

First Online: 17 November 2022

Declarations

:

: The CREDO clinical trial received ethical approval from the ethics committee of South-Western French Committee for the Protection of Persons (Bordeaux University Hospital, France, # 2016-A01587–44) and from the French National Drug Safety Agency (ANSM, # 2016111500034). Informed consent was obtained from all participants.The clinical study is conducted in accordance with:• The ethical principles of the latest version of the Declaration of Helsinki,• Good Clinical Practices (ICH version E6, 17/07/96 and decision of November 24, 2006),• The European Directive (2001/20/EC) on the conduct of clinical trials,• The Huriet law (n°88–1138) of December 20, 1988 relating to the Protection of Persons Lending themselves to Biomedical Research and modified by the Public Health law (n°2004–806) of August 9, 2004,• The French Data Protection Act n°78–17 of 6 January 1978 modified by the law n°2004–801 of 6 August 2004 relating to the protection of individuals with regard to the processing of personal data,• The French bioethics law n°2004–800 of August 6, 2004.

: Not applicable.

: The authors declare that they have no competing interests for this study.