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Article History

Received: 10 February 2025

Accepted: 15 April 2025

First Online: 19 May 2025

Declarations

:

: Yukari Okubo declares receiving grants or contracts from Eisai, Maruho Pharmaceutical, and Torii Pharmaceutical, and consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eisai, Eli Lilly, Janssen, JIMRO, Kyowa Kirin, LEO Pharma, Maruho Pharmaceutical, Mitsubishi Tanabe, Novartis, Pfizer, Sanofi, Sun Pharmaceutical Industries, Taiho Pharmaceutical, Torii Pharmaceutical, and UCB Japan. Ryuhei Okuyama declares receiving research grants, consulting fees, and/or speaker fees from AbbVie, Amgen, Boehringer Ingelheim, Eisai, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Maruho Pharmaceutical, Mitsubishi Tanabe, Novartis, Pfizer, Sun Pharmaceutical Industries, Taiho Pharmaceutical, Torii Pharmaceutical, and UCB Japan. Shinichi Imafuku has served as a consultant for, paid speaker for, accepted a research grant from, and/or participated in clinical trials sponsored by companies, including AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly, GSK, Janssen, Kyowa Kirin, LEO Pharma, Maruho Pharmaceutical, Meiji Seika, Novartis, Pfizer, Sun Pharmaceutical Industries, Taiho Pharmaceutical, Torii Pharmaceutical, Toyo Seiyaku Kasei, and UCB Japan. Yayoi Tada declares receiving honoraria and/or grants from AbbVie, Boehringer Ingelheim, Eisai, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Maruho Pharmaceutical, Mitsubishi Tanabe, Novartis, Sun Pharmaceutical Industries, Taiho Pharmaceutical, Torii Pharmaceutical, and UCB Japan. Keiichi Yamanaka has served as a clinical trial investigator for AbbVie, Boehringer Ingelheim, Eli Lilly Japan, LEO Pharma, Janssen, Maruho Pharmaceutical, Merck Sharp & Dohme, Parexel, and UCB Japan; received research funding from AbbVie, Eisai, Eli Lilly Japan, Kyowa Kirin, Maruho Pharmaceutical, Sasaki Chemical, Sun Pharmaceutical Industries, Taiho Pharmaceutical, and Torii Pharmaceutical; and received speaker fees and Chair fees from AbbVie, Astellas Seiyaku, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Kyowa Kirin, LEO Pharma, Maruho Pharmaceutical, Mitsubishi Tanabe, Nippon Kayaku, Nippon Zoki, Novartis, Sato Seiyaku, Sanofi, Sun Pharmaceutical Industries, Taiho Pharmaceutical, and Torii Pharmaceutical. Kazumitsu Sugiura declares receiving research grants, consulting fees, and/or speaker fees from AbbVie, Amgen, Bristol Myers Squibb, Eisai, Eli Lilly Japan, Janssen, Kyowa Kirin, LEO Pharma Japan, Maruho Pharmaceutical, Nippon Boehringer Ingelheim, Novartis, Taiho Pharmaceutical, Sun Pharmaceutical Industries, Torii Pharmaceutical, and UCB Japan. Yukie Yamaguchi declares receiving research grants, consulting fees, and/or speaker fees from AbbVie, Amgen, Astellas, Boehringer Ingelheim, Bristol Myers Squibb, Eisai, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Maruho Pharmaceutical, Mitsubishi Tanabe, Novartis, Sun Pharmaceutical Industries, Taiho Pharmaceutical, Torii Pharmaceutical, and UCB Japan. Masahito Yasuda declares receiving consulting fees and/or speaker fees from Boehringer Ingelheim, Janssen, Taiho Pharmaceutical, and Novartis, and participating in clinical trials sponsored by Eli Lilly. Wataru Sakamoto and Morihisa Saitoh are employees of Nippon Boehringer Ingelheim. Akimichi Morita declares receiving research grants, consulting fees, and/or speaker fees from AbbVie, Boehringer Ingelheim, Eisai, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Maruho Pharmaceutical, Mitsubishi Tanabe, Nichi-Iko, Nippon Kayaku, Novartis, Sun Pharmaceutical Industries, Taiho Pharmaceutical, Torii Pharmaceutical, and Ushio.

: The study protocol was approved by the ethics review committee of each institute as detailed in the supplementary information of the previous publication []. The study was performed in accordance with the Declaration of Helsinki. Written informed consent was obtained from patients (or their proxy if the patient was a minor or unable to provide informed consent) at a visit to the study site before registration of the patient on the electronic data capture system. Patients who were unlikely to visit the hospital because of transfer to a different hospital, or patients who had died, were registered for electronic data capture but were then opted out of follow-up. Instructions for opt-out were posted at the hospital or on its website.