Document is current

Article History

Received: 23 December 2025

Accepted: 16 February 2026

First Online: 11 March 2026

Declarations

:

: The trial was approved by a local or central institutional review board at each participating institution and conducted in accordance with the International Conference for Harmonisation guidelines, applicable regulations, and the Declaration of Helsinki. Participants provided written informed consent before screening. The study is registered with ClinicalTrials.gov (NCT04437433).

: Yasuhiko Matsumori reports personal consultancy fees from Amgen K.K., Astellas, BioPharma K.K., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., and Otsuka Pharmaceutical Co., Ltd. Akihiro Takahashi has received research funding/collaborative research expenses AbbVie GK and Pfizer Japan Inc. Shigeya Tanaka has received lecture fees from Amgen K.K., Daiichi Sankyo Co. Ltd., Eisai Co., Ltd., Otsuka Pharmaceutical Co. Ltd., and UCB Japan K.K., and has received collaborative research expenses from AbbVie GK, Amgen K.K., Eli Lilly Japan K.K., Lundbeck Japan K.K., Pfizer Japan Inc., and UCB Japan K.K. Takao Takeshima has been on the speakers’ bureau for Amgen K.K., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., and Otsuka Pharmaceutical Co., Ltd., and has received research funding/collaborative research expenses from AbbVie GK., Amgen K.K., Eli Lilly Japan K.K., Eisai Co., Ltd., Lundbeck Japan K.K., and Pfizer Japan Inc. Takao Takeshima also acted as an advisor to Hedgehog MedTech, Inc., Sawai Pharmaceutical Co., Ltd., and TEIJIN Pharma Ltd. Toshimasa Yamamoto has received honoraria from Eisai Co., Ltd., and Takeda Pharmaceutical Co., Ltd. Jia Bao, Hua Guo, Gina Ahmadyar, Rosa de Abreu Ferreira, Giovanna Forero, and Krisztian Nagy are employees of AbbVie and may hold AbbVie stock.