Wuyts, Wim A.
Dahlqvist, Caroline
Slabbynck, Hans
Schlesser, Marc
Gusbin, Natacha
Compere, Christophe
Maddens, Sofie
Lee, Yuan-Chi
Kirchgaessler, Klaus-Uwe
Bartley, Karen
Bondue, Benjamin
Funding for this research was provided by:
F. Hoffmann-La Roche, Ltd. (.)
Article History
Received: 22 March 2019
Accepted: 9 September 2019
First Online: 24 October 2019
Ethics approval and consent to participate
: The PROOF registry was conducted in accordance with the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guidelines for Good Clinical Practice, and local legal and regulatory requirements. Patients were required to provide informed consent prior to inclusion.PROOF is registered with the relevant authorities in Belgium and Luxembourg, with registration to Comité National d’Éthique et de Recherche (CNER) N201309/03–12 September 2013 and a notification to Comité National de Protection des Données (CNDP) for Luxembourg.
: Not applicable.
: W.A.W., C.D., H.S., and B.B. have received consulting and/or lecture fees from F. Hoffman-La Roche, Ltd. and Boehringer Ingelheim.M.S., N.G., C.C., and S.M. declare that they have no competing interests.Y.-C.L., K.-U.K., and K.B. are employees of Roche-Genentech and hold shares.