Conflict of interest

KA, MS, HY, YN, TK, KT, KB, HO, KH and SS declare no conflicts of interest. HSatake has received research funding from AsahiKASEI Co. Ltd., Ono Pharmaceutical Co. Ltd., Daiichi Sankyo, Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd. and Sanofi, honoraria from Bayer Co., Ltd., Bristol-Myers Squibb Co., Ltd., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eli Lilly Japan Co., Ltd., Merck Bio Pharma Co., Ltd., MSD Co., Ltd., Ono Pharmaceutical Co., Ltd., Sanofi Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Co., Ltd. and Yakult Honsha Co., Ltd. AM received honoraria from Eli Lilly, Japan K.K.; Taiho Pharmaceutical Co., Ltd.; Ono Pharmaceutical Co., Ltd.; Bristol-Myers Squibb Co., Ltd.; and Daiichi Sankyo Co., Ltd. HS received research funding from Taiho Pharmaceutical Co. Ltd. and Chugai Pharmaceutical Co. Ltd.. AT received honoraria for lectures from ELI LILLY JAPAN K.K., TAIHO PHARMACEUTICAL CO., LTD., ONO PHARMACEUTICAL Co., Ltd., CHUGAI PHARMACEUTICAL Co., Ltd., Merck Biopharma Co., Ltd., NOVARTIS PHARMA K.K., TAKEDA PHARMACEUTICAL COMPANY LIMITED, DAIICHI SANKYO CO., LTD, MSD K.K., TSUMURA & Co., AstraZeneca K.K., Sun Pharmaceutical Industries Limited, ASAHI KASEI PHARMA CORPORATION. HB received scholarship grants from Eli Lilly Japan and K.K. EO received research funding from Guardant Health and honoraria for lectures from Ono, Takeda, Bayer, Chugai, Taiho, Eli Lilly, and Bristol Myers Squibb.

Ethics statement

Approval of the research protocol by an Institutional Reviewer Board: Before the initiating the study, the principal investigator consulted a Certified Review Board (certification no. CRB718005), received approval from the study site manager, and submitted a trial plan to the Ministry of Health, Labour, and Welfare.

Informed consent statement

This study was conducted in accordance with the Good Clinical Practice guidelines and guiding principles detailed in the Declaration of Helsinki and in keeping with the applicable local law(s) and regulations (s). Written informed consent for the study procedures was provided by all candidate patients before enrolment.

Registry and the registration No. of the study/trial

This study was registered with the Japan Registry of Clinical Trials (registration number: jRCTs071190003).

Animal studies

Not applicable.