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Article History

Received: 20 July 2020

Revised: 16 October 2020

Accepted: 11 November 2020

First Online: 10 December 2020

Ethics approval and consent to participate

: All animal experiments were performed in accordance with Recommendations for Handling of Laboratory Animals for Biomedical Research compiled by the Committee on Safety and Ethical Handling Regulations for Laboratory Animal Experiments of Kindai University. The study was also approved by the Animal Ethics Committee of Kindai University. The authors followed the Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines for animal studies.

: Not applicable.

: The datasets generated and analysed in the study are available from the corresponding author on reasonable request.

: R.K. has received lecture fees from Bristol-Myers Squibb Co. Ltd.; and honoraria from Eli Lilly Japan K.K. K.H. has received honoraria from AstraZeneca K.K. and Ono Pharmaceutical Co. Ltd.; lecture fees from AS ONE Corporation, AstraZeneca K.K., Bristol- Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., MSD K.K., and Pfizer Japan Inc.; and research funding from AstraZeneca K.K. H.H. has received honoraria from AstraZeneca K.K., Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., MSD K.K., Ono Pharmaceutical Co. Ltd., Pfizer Japan Inc., Nippon Boehringer Ingelheim Co. Ltd., Novartis Pharma K.K., Merck Serono Co. Ltd., and Taiho Pharmaceutical Co. Ltd.; and research funding from AbbVie Inc., AC MEDICAL Inc., Astellas Pharma Inc., AstraZeneca K.K., Bristol-Myers Squibb Co. Ltd., Daiichi Sankyo Co. Ltd., Eisai Co. Ltd., Eli Lilly Japan K.K., EPS Associates Co. Ltd., GlaxoSmithKline K.K., Japan Clinical Research Operations Co. Ltd., Kyowa Hakko Kirin Co. Ltd., Merck Serono Co. Ltd., MSD K.K., Nippon Boehringer Ingelheim Co. Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co. Ltd., PAREXEL International Corp., Pfizer Japan Inc., PPD-SNBL K.K., Quintiles Transnational Japan K.K., Taiho Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., and Yakult Honsha Co. Ltd. K.S. has received honoraria from Becton Dickinson Co. Ltd.; and lecture fees from AstraZeneca K.K., Bio-Rad Laboratories, Inc., Chugai Pharmaceutical Co. Ltd., and Roche Diagnostics K.K., SRL, Inc. H.S. has declared no conflicts of interest. H.K. has received honoraria from AstraZeneca K.K., Bayer Yakuhin Ltd., Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Eli Lilly Japan K.K., MSD K.K., Ono Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., and Takeda Pharmaceutical Co. Ltd.; lecture fees from Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., MSD K.K., Ono Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., and Takeda Pharmaceutical Co. Ltd.; research funding from Chugai Pharmaceutical Co. Ltd. and Eisai Co. Ltd.; and consulting fees from Bristol-Myers Squibb Co. Ltd., Eli Lilly Japan K.K., MSD K.K., Ono Pharmaceutical Co. Ltd., and Taiho Pharmaceutical Co. Ltd. K.T. has received honoraria from AstraZeneca KK, Bristol-Myers Squibb, Eisai Co. Ltd., Merck Serono Co., and Ono Pharmaceutical Co. Ltd. M.T. has received honoraria from Chugai Pharmaceutical Co. Ltd., Nippon Boehringer Ingelheim Co. Ltd., Novartis Pharma K.K., and Ono Pharmaceutical Co. Ltd. K.Y. has received research funding from Daiichi Sankyo Co. Ltd.; and honoraria from Nippon Boehringer Ingelheim Co. Ltd. K.N. has received lecture fees from AstraZeneca K.K., Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd., Eli Lilly Japan K.K., Guardant Health Inc., Life Technologies Japan Ltd., MSD K.K., Nippon Boehringer Ingelheim Co. Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co. Ltd., Pfizer Japan Inc., Roche Diagnostics K.K., Sanofi K.K., Solasia Pharma K.K., SymBio Pharmaceuticals Ltd., and Yakult Honsha Co. Ltd.; and research funding from Astellas Pharma Inc., Eli Lilly Japan K.K., Ignyta Inc., Korea Otsuka Co. Ltd., Life Technologies Japan Ltd., and Nippon Boehringer Ingelheim Co. Ltd. K.N. has received honoraria from Astellas Pharma Inc., AstraZeneca K.K., AYUMI Pharmaceutical Co., Bristol-Myers Squibb Co. Ltd., CareNet Inc., Chugai Pharmaceutical Co. Ltd., Clinical Trial Co. Ltd., Daiichi Sankyo Co. Ltd., Eli Lilly Japan K.K., Hisamitsu Pharmaceutical Co. Inc., KYORIN Pharmaceutical Co. Ltd., Medical Review Co. Ltd., MEDICUS SHUPPAN Publishers Co. Ltd., MSD K.K., NANZANDO Co. Ltd., Nichi-Iko Pharmaceutical Co. Ltd., Nikkei Business Publications Inc., Nippon Boehringer Ingelheim Co. Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Pfizer Japan Inc., Reno. Medical K.K., and SymBio Pharmaceuticals Ltd., Taiho Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., Thermo Fisher Scientific K.K., YODOSHA Co. Ltd, and YOMIURI TELECASTING Co.; and research funding from A2 Healthcare Corp., AbbVie Inc., Astellas Pharma Inc., Bayer Yakuhin Ltd., Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., CMIC Shift Zero K.K., Covance Inc., Daiichi Sankyo Co. Ltd., Eisai Co. Ltd., Eli Lilly Japan K.K., EP-CRSU Co. Ltd., EPS Co., EPS international Co. Ltd., GlaxoSmithKline K.K., GRITSTONE ONCOLOGY Inc., ICON Japan K.K., inVentiv Health Japan, IQVIA Services JAPAN K.K., Kissei Pharmaceutical Co. Ltd., Kyowa Hakko Kirin Co. Ltd., Linical Co. Ltd., Merch Serono Co. Ltd., MSD K.K., Nippon Boehringer Ingelheim Co. Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co. Ltd., PAREXEL International Corp., Pfizer Japan Inc., Quintiles Inc., SymBio Pharmaceuticals Ltd., Taiho Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., and Yakult Honsha Co. Ltd.; and consulting or advisory fees from Astellas Pharma Inc., Eli Lilly Japan K.K., Ono Pharmaceutical Co. Ltd., and Takeda Pharmaceutical Co. Ltd.

: This study was supported financially by Nippon Boehringer Ingelheim.