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Article History

Received: 26 October 2023

Accepted: 10 November 2023

First Online: 1 February 2024

Declarations

:

: The study protocol was approved by an institutional review board or independent ethics committee at each study site. The trial was conducted in accordance with Good Clinical Practice guidelines and in compliance with the Declaration of Helsinki. Patients provided informed consent.

: Written informed consent was obtained from all individual participants included in the study.

: Dr. Nogami reports receiving lecture fees, honoraria, or other fees from AstraZeneca, Chugai Pharmaceutical Co., Ltd., and Eli Lilly Japan. Takaaki Tokito has received honoraria for lectures from Chugai Pharmaceutical, AstraZeneca, MSD, and Novartis. Yoshitaka Zenke has received payment or honoraria from AstraZeneca, Eli Lilly, Chugai Pharmaceutical, Ono Pharmaceutical, Bristol-Myers Squibb, Takeda Pharmaceutical, Boehringer-Ingelheim, Taiho, MSD, Novartis, Pfizer, Nippon-Kayaku, and Kyowa-Hakko Kirin; institution has received grants or contracts from MSD, Merck, AstraZeneca, Daiichi-Sankyo, and Amgen. Miyako Satouchi has received honoraria (lecture fees) from Chugai, AstraZeneca, Eli Lilly, Taiho, MSD, Pfizer, Novartis, Bristol-Myers Squibb, Ono, Takeda, Daiichi-Sankyo, Amgen, and Merck; and has received clinical trial funding from Chugai, AstraZeneca, MSD, Janssen, Amgen, Taiho, Bristol-Myers Squibb, Pfizer, Daiichi-Sankyo, and Eisai. Takashi Seto has received honoraria for lectures from AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Covidien Japan, Daiichi Sankyo, Eli Lilly Japan, Kyowa Hakko Kirin, MSD, Mochida Pharmaceutical, Nippon Boehringer Ingelheim, Novartis Pharma, Ono Pharmaceutical, Pfizer Japan, Taiho Pharmaceutical, Takeda Pharmaceutical, and Towa Pharmaceutical; institution has received grants or contracts from AbbVie, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Kissei Pharmaceutical, MSD, Novartis Pharma, and Pfizer Japan. Hideo Saka has received honoraria from Boston Scientific, Taiho, AstraZeneca, Ono, Boehringer-Ingelheim, Fuji film, JSRE, Eli Lilly, Chugai, Kaneka, and Century-Medical; has received research funding from Boston Scientific, MSD, AstraZeneca, Ono, Parexel International, WJOG, Celgene, and Taisho-Toyama. Junko Ohtani, Shirong Han, and Kazuo Noguchi are employees of MSD K.K., Tokyo, Japan. Makoto Nishio has received grants and personal fees from Ono Pharmaceutical, Bristol Myers Squibb, Pfizer, Chugai Pharmaceuticals, Eli Lilly, Taiho Pharmaceutical, AstraZeneca, MSD, Novartis, Daiichi Sankyo, and Takeda Pharmaceutical Company Limited; and has received personal fees from Boehringer-Ingelheim, Merck Biopharma, Teijin Pharma Limited, and AbbVie.