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Article History

Received: 21 March 2022

Accepted: 13 June 2023

First Online: 29 August 2023

Declarations

:

: The protocol is in accordance with the principles of the Declaration of Helsinki. Any changes to the protocol would be notified to the trial steering committee and the Ethics Committee first; then, the PI will notify to the partners and the PI will update the protocol in the clinical trial registry. The present trial was registered at the Committee for the Protection of People South Mediterranean IV (ID-RCB: 2020-A00688-31) on 09/06/2020.A commitment to comply with the MR001 of the CNIL has also been made. There are no other regulatory approaches. All participants will provide written informed consent before randomisation after the objectives and methodology of the trial have been explained to them in detail by the investigators. Participants have the right to withdraw from the trial at any time without giving a reason and will not be disadvantaged in any way for doing so. On the consent form, participants are asked if they agree to the use of their data should they choose to withdraw from the trial. Participants are also asked for permission for the research team to share relevant data with people from other institutions taking part in the research or from regulatory authorities, where relevant. This trial involves collecting biological specimens for storage. Investigators are responsible for ensuring that all participant data remains confidential. The participants’ personal information complies with the provisions of EU Regulation 2016/679 (European Parliament and of the Council of April 27, 2016, Data Protection). There is no anticipated harm and compensation for trial participation.

: Not applicable.

: The authors declare that they have no competing interests.