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Article History

Received: 8 April 2020

Accepted: 24 June 2020

First Online: 30 July 2020

Compliance with ethical standards

:

: Eiji Oki received lecture fee from Merck Biopharma Co., Ltd., Bayer Yakuhin Japan, Chugai Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Eli Lilly, Yakult Honsha Co., Ltd., and Takeda Pharmaceutical Co., Ltd. Akitaka Makiyama reports personal fees from Lily, personal fees from Chugai, personal fees from Takeda, outside the submitted work. Masahito Kotaka reports lecturefee from Chugai Pharmaceutical Co., Ltd., Yakult Honsha Co., Ltd., Takeda Pharmaceutical Company Limited, Merck Biopharma Co., Ltd., and Taiho Pharmaceutical Co., Ltd., outside the submitted work. Hideo Baba reports grants, personal fees and non-financial support from Taiho Pharmaceutical Co., Ltd., grants and non-financial support from Merck Biopharma Co., Ltd., during the conduct of the study; grants, personal fees and non-financial support from Ono Pharmaceutical Co., Ltd., grants, personal fees and non-financial support from Eli Lilly Japan K.K., grants and personal fees from Takeda Pharmaceutical Co., Ltd., grants and personal fees from Chugai Pharmaceutical Co., Ltd., grants from Shionogi & Co., Ltd., grants from Covidien Japan Inc., grants and non-financial support from Yakult Honsha Co.,Ltd., grants from Shin Nippon Biomedical Laboratories, Ltd., grants from Novartis-pharma K.K., grants from Toyama Chemical Co., Ltd., grants and non-financial support from Johnson & Johnson K.K., outside the submitted work. Other authors have no conflict of interest.

: This study was conducted in accordance with the Declaration of Helsinki and Ethical Guidelines for Clinical Studies in Japan, and the protocol was approved by the institutional review boards of all participating medical institutions. This study was registered in the UMIN clinical trials registry. (UMIN-CTR number UMIN000023329).

: The informed consent form stated that the results would be published after completion of the study. Consent of the family is not required at the time of article publication according to Japanese ethical guidelines.