Dziadzko, Mikhail http://orcid.org/0000-0001-5116-2171
Bouteleux, Axelle
Minjard, Raphael
Harich, Jack
Joubert, Fanny
Pradat, Pierre
Pantel, Solene
Aubrun, Frederic
Funding for this research was provided by:
fondation apicil (968.16)
Article History
Received: 11 June 2021
Accepted: 9 May 2022
First Online: 21 May 2022
Declarations
:
: This study was approved by the Institutional Review Board (N°IDRCB : 2018-A00010-55) and granted by the ethical committee CPP Sud Méditerranée 3 2018.05/04, last revision 04/02/2021This trial is conducted in accordance with the protocol and in compliance with the moral, ethical and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). It is also conducted in accordance with French legislation (Public Health Code; Act No. 2004–806 of 9 August 2004). It is registered in the Clinical Trial Protocol Registration and Results System: NCT03754699). An ethics committee (Comité de Protection des Personnes Sud Méditerranée 3, CPP) has approved the study.
: The French version model of consent form is available as Supplementary material
: The authors declare that they have no competing interests.