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Article History

Received: 16 December 2020

Accepted: 26 March 2021

First Online: 15 April 2021

Declarations

:

: The study will be conducted in accordance with legal and regulatory requirements, as well as the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences, 2002), Guidelines for Good Clinical Practice (International Conference on Harmonization, 1996), and the Declaration of Helsinki (World Medical Association 1996 and 2008). In addition, the study will be conducted in accordance with the protocol, the International Conference on Harmonization Guideline on Good Clinical Practice, and applicable local regulatory requirements and laws (law n°2004-806, august 9th 2004). This protocol obtained a favorable opinion of the Independent Ethics Committee (art. L1123-6 of French Public Health Code) on December 20, 2017, and the National Agency for the Safety of Medicines and Health Products (ANSM) was informed on January 22, 2018. All participants of the study will sign an informed consent form. Agreement of their legal guardian for patients under guardianship will be asked. The promoter of this research, the Centre Hospitalier du Rouvray, 4, rue Paul Eluard, 76300 Sotteville-lès-Rouen, has purchased civil liability insurance from the Société Hospitalière d’Assurance Mutuelle (contract No. 124916).

: Not applicable.

: The authors declare that they have no competing interests.