Le Berre, C.
Bourreille, A.
Flamant, M.
Bouguen, G.
Siproudhis, L.
Dewitte, M.
Dib, N.
Cesbron-Metivier, E.
Goronflot, T.
Hanf, M.
Gourraud, P.-A.
Kerdreux, E.
Poinas, A.
Trang-Poisson, C.
Article History
Received: 6 September 2018
Accepted: 27 March 2020
First Online: 16 April 2020
Ethics approval and consent to participate
: As questionnaires are given in common practice in the 3 centres, this trial does not correspond to the French legislation of the Loi Jardé (Article L1121-4 amended by Ordinance No. 2016-800 of 16 June 2016 - Art. 1). The VALIDate study is considered as a non-interventional study based on data collection of consultations carried out during follow-up care of patients; no authorization is requested from the French regulatory authorities. Patients will be informed that the data collected in their medical records will be used in this study. Their oral non-opposition will be collected after reading the information letter (Annex InternalRef removed) and noted in the medical record as required.This study was approved by the local Research Ethics Committee (GNEDS) on 18 May 2018.The trial is registered in ClinicalTrials.Gov with registration number NCT 03590639, registered 18 July 2018.
: Not applicable.
: Guillaume Bouguen: member of the editorial board of BMC Gastroenterology.The other authors declare that they have no competing interests.No publication containing the results of this study has been published or submitted to any journal yet.