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Article History

Received: 28 July 2019

Accepted: 22 November 2019

First Online: 28 November 2019

Ethics approval and consent to participate

: All participants provided written informed consent, and this study was approved by the medical/ethics review boards of Asahi, Chugoku, Ehime, Hamamatsu, Hokkaido Chuo, Kansai, Kanto, Nagasaki, Niigata, Osaka, Tohoku, and Yokohama Rosai Hospitals, and Kansai University of Welfare Sciences.

: Not applicable.

: All authors declare the following potential conflicts of interest: KM is a shareholder and adviser of Trunk Solution CO., Ltd. KM received the following support: a research grant from the Ministry of Health, Labour and Welfare for the submitted work; grant support, including an endowed chair from Sumitomo Dainippon Pharma Co., Ltd. and Okamura Corporation; grant support, including an endowed chair and lecture fees from AYUMI Pharmaceutical Corporation, Nippon Zoki Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., LTD., Eli Lilly Japan K.K., Astellas Pharma Inc., TOTO LTD., and Eisai Co., Ltd.; lecture fees from Pfizer Japan Inc., Hisamitsu Pharmaceutical Co., Inc., Janssen Pharmaceutical K.K., Kaken Pharmaceutical Co., LTD., and Teijin Pharma Limited; and lecture fees and advisory fees from Shionogi & Co., Ltd. MTG Co., Ltd., Sompo Holdings, Inc., NUVASIVE Japan, Murata Manufacturing Co., Ltd. outside the submitted work. HO received grants from Teijin Pharma Limited, Pfizer Inc., and Fujifilm Medical Co., Ltd.; grants and personal fees from AYUMI Pharmaceutical Corporation, Nippon Zoki Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., LTD. MTG Co., Ltd., Sompo Holdings, Inc., and NUVASIVE Japan; and grants from Eli Lilly Japan K.K. outside the submitted work. ST received personal fees for expert testimony from Amgen Inc., Asahi Kasei Pharma Corporation, Amgen Astellas BioPharma K.K., Ono Pharmaceutical Co., LTD., Kyocera Medical Corporation, Daiichi Sankyo Company, Limited, Teijin Pharma Limited, Eli Lilly Japan K.K., and Pfizer Japan Inc.; endowments from Astellas Pharma Inc., AYUMI Pharmaceutical Corporation, Pfizer Japan Inc., Bristol-Myers Squibb, Daiichi Sankyo Company, Limited, and Chugai Pharmaceutical Co., Ltd.; and grants from the Japan Agency for Medical Research and Development, the Japan Society for the Promotion of Science (JSPS)/Grant-in-aid for Scientific Research (A), and the JSPS/Grant-in-aid for Exploratory Research outside the submitted work. TF reports grants from Murata Manufacturing Co., Ltd. outside the submitted work. KT, FA, TN, KK, and HO have no competing interests to report.