Conflict of interest

MS (Janssen Pharmaceutical K.K., AstraZeneca, Astellas Pharma Inc.), HM (Janssen Pharmaceutical K.K., Chugai Pharmaceutical Co., Ltd.), TK (AstraZeneca, Merck Biopharma Co., Ltd.), HE (Astellas Pharma Inc.), TI (Astellas Pharma Inc., Janssen Pharmaceutical K.K.), AY (Astellas Pharma Inc., Janssen Pharmaceutical K.K.), ME (Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Novartis Pharma K.K., Pfizer Japan Inc., Bristol-Myers Squibb Co., Janssen Pharmaceutical K.K., MSD K.K., Merck Biopharma Co., Ltd., AstraZeneca, Eisai Co., Ltd.), have lecture fees, honoraria, or other fees from each entity. MS (Daiichi Sankyo Co., Ltd.), HM (Janssen Pharmaceutical K.K.), TK (Janssen Pharmaceutical K.K., Shin Nippon Biomedical Laboratories, Ltd., Ono Pharmaceutical Co., Ltd., Bayer Yakuhin, Ltd., Sanofi K.K., Takeda Pharmaceutical Co., Ltd.), ME (Bristol-Myers Squibb Co., Ono Pharmaceutical Co., Ltd., Eisai Co., Ltd., Taiho Pharmaceutical Co., Ltd., MSD K.K.) have research funds from each entity. ME (Sanofi K.K., Bayer Yakuhin, Astellas Pharma Inc, Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd.), HideM (Kyowa Kirin Co., Ltd., Takeda Pharmaceutical Co., Ltd.) have scholarship (incentive) endowments or research grants from each entity. LB, NF, HS and SN have no COI to disclose.

Approval of the research protocol by an institutional reviewer board

This study was approved by the central Institutional Review Board (14-E02). The study was performed in accordance with the Declaration of Helsinki.

Registry and the registration number of the study/trial

UMIN000014243.

Consent to participate

A written informed consent was obtained from each participant.