Weber, Michel
Dominguez, Marcel
Coscas, Florence
Faure, Céline
Baillif, Stéphanie
Kodjikian, Laurent
Cohen, Salomon-Yves
Funding for this research was provided by:
Bayer HealthCare SAS (n/a)
Article History
Received: 3 March 2020
Accepted: 8 May 2020
First Online: 25 May 2020
Ethics approval and consent to participate
: No Independent Ethics Committee and Institutional Review Board approval was obtained due to the study’s observational design in accordance with the requirements of local law and regulations in France. The protocol was reviewed and approved by a French data privacy committee: Comité Consultatif sur le Traitement de l’Information en Matière de Recherche dans le Domaine de la Santé (CCTIRS) and Commission Nationale de l’Informatique et des Libertés (CNIL). Bayer France received a positive statement from the CCTIRS on 18 June 2014 and an authorization from the CNIL on 14 October 2014 for the RAINBOW study. They gave Bayer the possibility to collect, analyze and use anonymized data of patients included in this study. All patients provided written informed consent to participate.
: Not applicable.
: MW reports personal fees from Bayer, outside the submitted work; MD reports support with clinical studies from Bayer and Novartis, during the conduct of the study and outside of the submitted work; FC reports personal fees from Bayer, personal fees from Novartis, personal fees from Roche, outside the submitted work; CF reports grants from Novartis, grants from Allergan, grants from Bayer, outside the submitted work; SB reports personal fees and other from Bayer Healthcare, personal fees and other from Horus Pharma, personal fees and other from Novartis SAS, personal fees and other from Allergan SAS, outside the submitted work; LK reports grants and personal fees from Allergan, personal fees from Bayer, grants and personal fees from Novartis, outside the submitted work; SYC reports personal fees from Bayer, during the conduct of the study; personal fees from Novartis, personal fees from Bayer, personal fees from Allergan, personal fees from Thea, personal fees from Tilak, personal fees from Roche, outside the submitted work.