Funding for this research was provided by:
Office for State, Tribal, Local and Territorial Support (14 7316 02)
Received: 29 September 2020
Accepted: 21 January 2021
First Online: 18 February 2021
Consent for publication
: The patients in this manuscript have given written informed consent to publication of their case details.
: The study protocol was approved the 25, February 2015 by the institutional ethics committee (<i>Comité de Protection des Personnes</i>—Aquitaine, Bordeaux, France) and the 31, July 2015 by the French national health authority, ANSM (<i>Agence Nationale de Sécurité du Médicament et des produits de santé</i>). The implementation agreement was signed by the sponsor the 31, August 2015. The study was conducted in accordance with the principles of the Declaration of Helsinki 1975, revised 1983, and registered the 2, June 2015 under the European database Eudract identifier 2015-000379-29 and the 25, May 2016 under the ClinicalTrials.gov identifier NCT02782702 (ExternalRef removed). Written consent was obtained from all patients.
: The authors declare that they have no competing interests.