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Article History

Received: 17 October 2016

Accepted: 16 January 2018

First Online: 6 February 2018

Ethics approval and consent to participate

: In accordance with the Declaration of Helsinki and French regulation on clinical trials, authorizations were obtained for all French participating centers from the following: the Comité de Protection des Personnes (Ethics Committee) on 10 December 2013, the Agence Nationale de Sécurité du Médicament et des produits de santé (French Health Products Safety Agency) on 13 January 2014, the Comité Consultatif sur le Traitement de l’Information en Matière de Recherche dans le Domaine de la Santé (Advisory Committee on Processing Information Associated with Health Research) on 12 March 2014, and the Commission Nationale Informatique et Libertés (French Data Protection Authority) on 23 December 2014.The sponsor of the FREGAT CBD is the Lille University Hospital, Lille, France. An insurance policy has been taken out, and all patients are required to receive an information letter and sign a consent form.The FREGAT CBD is registered on the website under the number NCT 02526095 and is also in the Health Databases Catalogue ().

: Not applicable

: The authors declare that they have no competing interests.

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