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Article History

Received: 24 May 2023

Accepted: 13 June 2023

First Online: 29 July 2023

Declarations

:

: The TERTIO trial is carried out in accordance with relevant guidelines and regulations. The investigator commits to the fact that this study is realized in accordance with the law of public health n°2012–300 of March 5^th, 2012, concerning the biomedical researches, the application decree N 2006–1537 of November 16^th, 2016, the ordonnance n°2016–800 of June 16^th, 2016 modifying the chapter I^st of the title II of the 1^st book of the first part of the public health code concerning the biomedical researches as well as the current orders. The investigator and the sponsor make a commitment to follow the rules of Good Clinical Practice of the biomedical researches concerning medicine with human use, mentioned in the article L. 1121–3 of the public health code and to the order of April 23^rd, 2004. The current study is conducted in accordance with globally accepted standards of Good Clinical Practice, the revised version of the Declaration of Helsinki set out in the European Directive, as well as with the Certificate Service Providers specific to France.Institutional Review Board/Independent Ethics Committee (IRB/IEC):To the extent that a specific research intervention is performed, the protocol falls within the scope of research involving humans. Regarding intervention research involving intervention on the person not justified by their usual care, this study received for its implementation: an approval from the independent Ethics Committee (Committee for Protection of Persons) “Est IV” dated July 7^th 2022 and an authorization from health authorities (French National Agency for the Safety of Medicines and Health Products) dated August 1^st 2022.Informed consent:The Investigator (according to applicable regulatory requirements), or a person designated by the Investigator and under the Investigator’s responsibility, should orally inform the patient and gives an information note to each subject, before their inclusion in the trial. If the subject wishes to participate in the trial, he signs the consent before any intervention or procedure specified in the protocol. The investigator countersigns the consent. All participants should be informed to the fullest extent possible about the study, in language and terms they are able to understand.

: Not applicable.

: The authors declare no competing interests.