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Article History

Received: 29 April 2024

Revised: 1 June 2024

Accepted: 16 June 2024

First Online: 11 July 2024

Competing interests

: K Kirito received honoraria for lectures, presentations, speaking engagements, manuscript writing, or educational events from AbbVie G.K., Novartis Pharma K.K., PharmaEssentia Japan K.K., Sanofi K.K., and Takeda Pharmaceutical Co., Ltd. A Qin is the chief medical officer of PharmaEssentia Corporation. K Shimoda is a consultant for Sierra Oncology, Inc. and reports research funding from AbbVie G.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Kyowa Kirin Co., Ltd., Mochida Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Otsuka Pharmaceutical Co., Ltd., PharmaEssentia Japan K.K., Shionogi & Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., and Takeda Pharmaceutical Co., Ltd. and honoraria from Takeda Pharmaceutical Co., Ltd., and Novartis Pharma K.K.; and is a member of an advisory committee for AbbVie G.K. N Komatsu is a board member of and received funding for medical writing and article processing charges from PharmaEssentia Japan K.K. and received research funding from Meiji Seika Pharma Co., Ltd. and consulting fees from Torii Pharmaceutical Co., Ltd. T Sato is employed by PharmaEssentia Japan K.K. O Zagrijtschuk is employed by PharmaEssentia USA. D Wu is employed by Biotech (Beijing) Ltd. S Suo, R Fu, and J Jin have no conflict of interest to disclose.

: Both A19-201 and A20-202 were conducted in compliance with the ethical standards of the responsible institution regarding human subjects. The studies were approved by the ethics committee or IRB of the participating institutions and followed the principles of the Declaration of Helsinki for all human experimental investigations. The institutions are Juntendo University School of Medicine Hospital; Mie University Hospital; Tokyo Medical University Hospital; Ehime University Graduate School of Medicine Hospital; Osaka University Graduate School of Medicine Hospital; Keio University School of Medicine Hospital; NTT Medical Centre Tokyo University of Yamanashi Hospital; The First Affiliated Hospital, Zhejiang University School of Medicine; Institute of Haematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; The Second Hospital of Tianjin Medical University; The First Affiliated Hospital of Soochow University; Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital; Nanfang Hospital of Southern Medical University; Ruijin Hospital, Shanghai Jiaotong University School of Medicine; Zhongnan Hospital, Wuhan University; Shenzhen Second People’s Hospital; The First Affiliated Hospital of Chongqing Medical University; Huashan Hospital of Fudan University; The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China.

: Written informed consent was obtained from all participating patients.