Text and Data Mining valid from 2020-02-10
Received: 16 October 2019
Accepted: 18 December 2019
First Online: 10 February 2020
Ethics approval and consent to participate
: This study will be conducted in accordance with the Declaration of Helsinki. According to French law, the study protocol has been reviewed and the French ethics committee (south west and overseas III Protection to Person Committee) approved the study for all centres on 26 September 2018. This RCT has been registered at clinicaltrial.gov (number NCT03786549 on 17 December 2018).Any substantial change is subject to a written amendment submitted to the promoter, who must obtain a favourable opinion from the Protection to Person Committee before implementation. All amendments to the protocol must be made known to all investigators involved in the research.According to French law, all patients and caregivers will be verbally informed about the study and will receive an information form. For inclusion, the patient (i.e. under 18 years of age in France) will give oral consent and the patient’s caregiver the written informed consent for patient participation. When the patient legally becomes an adult (i.e. at 18 years of age in France), he will give his/her own written informed consent.
: Not applicable.
: The authors declare that they have no competing interests.
: contactable to email@example.com is composed of: Delphine Hoegy, Audrey Janoly-Dumenil, Nathalie Bleyzac, Alexandra Gauthier-Vasserot, Giovanna Cannas, Arnaud Hot, Yves Bertrand, Pauline Occelli, Sandrine Touzet, Angélique Denis, Claude Dussart, Stéphanie Poupon-Bourdy, Fanny Nusbaum, Daniela Cuzzubbo, Karim Khadem, Ronald Guilloux.