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Article History

Received: 5 April 2019

Accepted: 30 October 2019

First Online: 12 December 2019

Ethics approval and consent to participate

: The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. The United States of America Quorum Review independent review board approved the study (approval number 29659). Approval was obtained for each of the study sites (109 in total), and all patients provided written informed consent.

: Not applicable.

: MCG has received grants from AbbVie, Amgen, and Pfizer. MCG has also received consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Galapagos, FKB, Gilead, UCB, Merck, Samsung, Novartis, Regeneron, and Sanofi. JG has received personal fees from FKB. MG reports grants from Fujifilm, AbbVie, Amgen, Gilead, Lilly, Merck, and Pfizer during the conduct of the study, and other funds from Lilly, Pfizer, and Gilead outside of the study. JIV reports personal fees from Syneos Health Clinical Solutions during the conduct of the study. MS has received personal fees from AbbVie, Amgen, Boehringer Ingelheim, Fujifilm, Galapagos, Gilead, Merck, Lilly, Novartis, Pfizer, Regeneron, Samsung, and Sanofi during the conduct of the study. EB has received personal fees from Abbott, Bayer, Boehringer Ingelheim, Servier, and Berlin-Chemie Menarini. RA has received grants from Amgen and Pfizer. RA has also received consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Galapagos, FKB, Gilead, Lilly, UCB, and Novartis. WP, ECEK, HK, MK, and ED declare that they have no competing interests.