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Article History

Received: 30 April 2021

Accepted: 16 February 2022

First Online: 4 March 2022

Declarations

:

: The study was approved by the ethics committee “Committee for the Protection of Persons and Competent Authority” (CPP of Ile de France VII, 05 December 2018). Prior to enrolment, all participants receive the informed consent form by regular mail or e-mail. The investigator delivers then all the necessary information about the study by a phone call according to the design of the study. Prior to any assessment and intervention, all participants granted a verbal informed consent as trial participation involves minimal risks. If participants do not have capacity to consent, we will attempt to identify their close relatives or legal representatives to give proxy assent. The verbal informed consent forms are then signed by the investigator and stored in locked file cabinets in areas with limited access. A sample of each consent form is sent to the participant by regular mail. Our consent procedure has been approved by ethics committee. The study was conducted in accordance with Good Clinical Practice, applicable local regulatory requirements, and the guiding principles of the Declaration of Helsinki.

: No individual person’s data is included in the manuscript.

: The authors declare that there are no conflicts of interest.