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Article History

Received: 14 November 2017

Accepted: 4 February 2018

First Online: 7 March 2018

Ethics approval and consent to participate

: The study protocol was approved by the institutional review board (Keio University Hospital) of the lead investigator (TT) and by the institutional review boards of each of the 20 other participating study sites. The study was conducted in accordance with the Declaration of Helsinki consistent with Good Clinical Practices and applicable regulatory requirements. All participants provided written informed consent.

: Not applicable.

: TT has received research grants from Astellas Pharma, Bristol-Myers K.K., Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Eisai Co. Ltd, Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Santen Pharmaceutical Co. Ltd, Takeda Pharmaceutical Co. Ltd, Teijin Pharma Ltd, AbbVie GK, Asahi Kasei Pharma Corp., Taisho Toyama Pharmaceutical Co. Ltd and SymBio Pharmaceuticals Ltd; has received consulting fees from Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Asahi Kasei Medical K.K., AbbVie GK, Daiichi Sankyo Co. Ltd, Bristol-Myers K.K. and Nippon Kayaku Co. Ltd; and has received speaking fees from AbbVie GK, Bristol-Myers K.K., Chugai Pharmaceutical Co. Ltd, Eisai Co. Ltd, Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Takeda Pharmaceutical Co. Ltd, Astellas Pharma, Daiichi Sankyo Co. Ltd, Celtrion and Nippon Kayaku Co. Ltd.HY has received research grants from AbbVie, Asahi Kasei, Astellas, AstraZeneca, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, GlaxoSmithKline, Janssen Pharmaceutical Product, L.P., Mitsubishi Tanabe, MSD, Nippon Kayaku, Pfizer Inc., Santen, Taisho Toyama, Takeda and Teijin; has received consulting fees from AbbVie, Astellas, AstraZeneca, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Mitsubishi Tanabe, Nippon Kayaku, Pfizer Inc., Takeda and Teijin; and has served on a speakers’ bureau for AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe, Pfizer Inc., Takeda and Teijin.MH has received research grants from AbbVie Japan, Astellas Pharma, Bristol-Myers Squibb, Chugai Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Ono Pharmaceuticals, Santen Pharmaceutical, Takeda Pharmaceutical, UCB Japan and Teijin Pharma; and has received consulting fees from AbbVie Japan, Janssen Pharma, Chugai Pharmaceutical, Teijin Pharma, Eli Lilly Japan and Zenyaku Kogyo.YT has received research grants from Mitsubishi-Tanabe, Takeda, Daiichi-Sankyo, Chugai, Bristol-Myers, MSD, Astellas, Abbvie and Eisai; and has received consulting fees from Abbvie, Chugai, Daiichi-Sankyo, Bristol-Myers, Mitsubishi-Tanabe, Astellas, Takeda, Pfizer, Teijin, Asahi Kasei, YL Biologics, Sanofi, Janssen, Eli Lilly and GlaxoSmithKline.RT, YK, YU and TN are employees of Janssen Pharmaceutical K.K.BH is an employee and stockholder of Johnson & Johnson.

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