Carré, Chloé
Acar, Niyazi
Daruich, Alejandra
Grégoire, Stéphane
Martine, Lucy
Buteau, Bénédicte
Aho, Serge
Eid, Petra
Arnould, Louis
Bron, Alain Marie
Driessen, Marine
Kermorvant, Elsa
Simon, Emmanuel
Creuzot-Garcher, Catherine
Gabrielle, Pierre-Henry
Funding for this research was provided by:
Conseil régional de Bourgogne-Franche-Comté (2021Y - 06998)
Article History
Received: 10 January 2023
Accepted: 26 September 2023
First Online: 6 October 2023
Declarations
:
: The clinical study will be conducted in accordance with the relevant versions of the French and European laws (no. 2021–300 of 5 March 2021 related to research involving humans, amended by order no. 2016–800 of 16 June 2016 and its implementing decrees), the Declaration of Helsinki, and the recommendations of Good Clinical Practice.In accordance with article L1121-1 of the Public Health Code, this study constitutes research of category 3 involving human participants, in that it constitutes risk-free research in which all procedures are performed and products are used in the standard way.This clinical study was submitted to and approved by the Ethical Review Board of Dijon (<i>Comité de Protection des Personnes</i> – CPP Ouest III—Dijon) on 7 February 2021, and two amendments were submitted and approved on 30 August 2021 (new inclusion site added) and 24 August 2022 (extension of inclusion time).
: Not applicable.
: The authors declare no competing interests.