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Article History

Received: 27 July 2017

Accepted: 6 December 2018

First Online: 7 January 2019

Ethics approval and consent to participate

: The study was approved by ethics committees and conducted in accordance with the International Conference on Harmonisation Guidelines for Good Clinical Practice and the Declaration of Helsinki. Each site used a different ethics committee (detailed in Additional file IRB Table). Written informed consent was obtained from each patient before any protocol-specific procedure.

: Not applicable.

: TS was a coordinating investigator and has received funding from, held board membership for, spoken at scientific meetings for, prepared manuscripts for, and had consulting agreements with Astellas, Biogen, Bayer-Schering, Daiichi-Sankyo, Eisai, Kaketsuken, Merck Serono, Mitsubishi-Tanabe, Nihon, Novartis, Ono, Sanofi, TDS Japan, and Teijin.TY (Multiple Sclerosis Center, National Center of Neurology and Psychiatry) is a member of scientific advisory boards for Biogen and Chugai; received research support from Asahi Kasei Kuraray, Chugai, Mitsubishi Tanabe, Ono, and Teva; received speaker honoraria from Abbot Japan, Astellas, Bayer, Biogen, Dainippon Sumitomo, Eisai, Mitsubishi Tanabe, Nihon, Novartis, and Santen; and is funded by the Japanese Ministry of Health, Labour and Welfare and the Japan Society for the Promotion of Science.TK has received research support from Bayer HealthCare, Biogen, Eisai, Mitsubishi Tanabe, Novartis, and Takeda, and speaker honoraria from Bayer, Biogen, Daiichi Sankyo, Eisai, Mitsubishi Tanabe, and Novartis.JY, MY, LM, BZ, and SIS are full-time employees of and hold stock/stock options in Biogen.JL has nothing to disclose.

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