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Article History

Received: 6 July 2017

Accepted: 30 April 2018

First Online: 19 June 2018

Ethics approval and consent to participate

: The protocol received approval from the institutional review board and independent ethics committee of the investigational centers and was performed in accordance with the Declaration of Helsinki. All patients provided written consent prior to study participation, and the trial was conducted in compliance with institutional review board regulations, the International Conference on Harmonisation Guidelines for Good Clinical Practice, and the Declaration of Helsinki. The specific ethical bodies that approved study are as follows: Comité de Ética Científico, S.S.M. Oriente, Chile; Eticka komise, Revmatologickeho ustavu, Czech Republic; EK FN Královské, Vinohrady, FN Kralovske Vinohrady, Czech Republic; Eticka komise, Uherskohradistske nemocnice, a.s., Czech Republic; Ethik-Kommission des Landes Berlin, Landesamt für Gesundheit und Soziales, Berlin, Germany; Medical Research Council, Ethics Committee for Clinical Pharmacology, Hungary; Ethics Committee of Tel Aviv, Sourasky Medical Center, Israel; EC of Sheba Medical Center, The Chaim Sheba Medical Center, Israel; Ethics Committee of Carmel Medical Center, Israel; Seoul National University Hospital, Republic of Korea; Eulji University Hospital, Republic of Korea; Keimyung University, Dongsan Medical Center, Republic of Korea; CE de la asociación benéfica Prisma Carlos Gonzales, Peru; Komisja Bioetyczna przy Okregowej Radzie Lekarskiej WIL, Poland; National Bioethics Committee of Medical Product and Medical Devices, Romania; LEC of the Scientific Research Institute of Rheumatology, Russian Federation; Ethics Board at Ministry of Health of the Russian Federation, Russian Federation; LEC of the Kemerovo State Medical Academy, Russian Federation; LEC of the Saintpetersburg I.I. Dzhanelidze Research Institute, Russian Federation; LEC of Saratov Regional Clinical Hospital, Russian Federation; LEC of ‘Applied Medicine’, Russian Federation; LEC of the Moscow City Hospital n.a. S. P. Botkin, Russian Federation; LEC of the City Clinical Hospital n.a. M.E. Zhadkevich, Russian Federation; Pharma Ethics (Pty) Ltd., South Africa; CEIC Corporació Sanitària del Parc Taulí, Spain; LEC of the Regional Clinical Hospital n.a. N.I. Pyrogov, Ukraine; LEC of Consultative Diagnostic Center of Pechersky District, Ukraine; LEC of the Ivano-Frankivsk Regional Clinical Hospital, Ukraine; LEC of Lutsk Regional Hospital, Ukraine; LEC of Vinnytsya City Clinical Hospital #1, Ukraine; LEC of Lviv Regional Clinical Diagnostic Center, Ukraine; LEC Kyiv City Clinical Hospital #3, Ukraine; LEC of MIHC Regional Clinical Hospital, Ukraine; LEC of Poltava Regional Clinical Hospital n.a. Sklyfosofsky, Ukraine; NRES Committee London – London Bridge National Research Ethics Service, United Kingdom; Chesapeake IRB, United States; Comité de Protection des Personnes Est III Hôpital de Brabois, France; Ethics Committee of Bnei Zion Medical Center Bnei Zion, Israel; Ethics Committee of Rambam Medical Center, Israel; Ajou University Hospital, Republic of Korea; Chungnam National University Hospital, Republic of Korea; Chosun University Hospital, Republic of Korea; Dong-A University Hospital, Republic of Korea; Wits Human Research EC, South Africa; Dartmouth Medical School IRB, United States.

: VS is a consultant for AbbVie, Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Celltrion, Corrona, Crescendo, Genentech/Roche, GSK, Janssen, Eli Lilly & Co., Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, and UCB. LG is a member of an institution that received research funding for the present study; a consultant for AbbVie, BMS, Genentech/Roche, Janssen, Eli Lilly & Co., Novartis, Pfizer, and UCB; and a member of the executive committee of the Outcome Measures in Rheumatology initiative. GRB is a member of an institution that received research funding from Sanofi and Regeneron Pharmaceuticals, Inc., for the present study. CWJP, SG, YL, HvH, and MR are employees of and shareholders in Sanofi. TK, CIC, and JvA are employees of and shareholders in Regeneron Pharmaceuticals, Inc. EKM is a shareholder of Pfizer Inc., and Regeneron Pharmaceuticals, Inc., and an employee of Regeneron Pharmaceuticals, Inc.

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