Ethics approval and consent to participate
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 5Institutional 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 7Informed 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.