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Authors
Breuker, Cyril http://orcid.org/0000-0002-9023-2686
Faucanié, Marie
Laureau, Marion
Perier, Damien
Pinzani, Véronique
Marin, Grégory
Sebbane, Mustapha
Villiet, M.
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Funding
Funding for this research was provided by:
Direction Générale de l’offre de Soins (PREPS-17-0396)
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Article History
Received: 6 April 2021
Accepted: 29 July 2021
First Online: 6 August 2021
Declarations
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: The trial will be conducted in compliance with the protocol, the principles of GCP, and the declaration of Helsinki. This study has been approved by the ethics committee CPP Ouest III – Poitiers (2018-A01717-48) and declared to the National agency for drugs (ANSM). Any revisions/amendments to the protocol will not be permitted without prior approval by the study steering committee. The steering committee will consist of a representative of the sponsor, the methodologist, the health economist, a medical investigator, a pharmacovigilant, and the coordinating investigator. The steering committee will meet before the start of the study to prepare the setting up of the study, and then during the study, follow-up meetings will be organized.Any amendments to the protocol will require ethics committee approval and competent authority information prior to implementation of any changes made to the study design. Study registration NCT03725046 will be updated at any amendments. Written informed consent will be obtained from each participant at the time of enrolment.
: The authors declare that they have no competing interests.
