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Article History

Received: 3 August 2022

Accepted: 2 November 2022

First Online: 21 November 2022

Declarations

:

: Nobuyuki Katakami: Support for the present manuscript (funding): WJOG. Grants: Chugai Pharmaceutical, Ono Pharmaceutica, MSD, and Delta-Fly Pharmaceutical. Payment for lectures, presentations, and speakers bureaus: Chugai Pharmaceutical, Ono Pharmaceutica, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Novartis, Pfizer, and Takeda. Toshihide Yokoyama: Grants: Bristol-Myers Squibb, MSD, Boehringer Ingelheim, Takeda, and Chugai Pharmaceutical. Payment for lectures, presentations, and speakers bureaus: AstraZeneca, Chugai Pharmaceutical, Eli Lilly, Pfizer, Bristol-Myers Squibb, Ono Pharmaceutical, Takeda, and Nippon Kayaku. Satoshi Morita: Grants: Eisai. Payment for lectures, presentations, and speakers bureaus: AstraZeneca, Taiho Pharmaceutical, Chugai Pharmaceutical, Boehringer Ingelheim, Bristol Myers Squibb, Novartis, MSD, Kyowa Kirin, Astellas, Pfizer, Ono Pharmaceutical, and Eli Lilly Japan. Tatsuro Okamoto: Grants: AnHeart Therapeutics, AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Covidien Japan, Daiichi Sankyo, Eli Lilly, KM Biologics, Merck Biopharma, MSD, Nippon Boehringer Ingelheim, Nippon Kayaku, Novartis, Pfizer, and Taiho. Payment for lectures, presentations, and speakers bureaus: AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly, Johnson & Johnson, MSD, Nippon Boehringer Ingelheim, Nippon Kayaku, Novartis, Ono Pharmaceutical, Taiho, and Towa Pharmaceutical. Yoshiko Urata: Grants: none. Payment for lectures, presentations, speakers bureaus: none. Yoshihiro Hattori: Grants: Chugai Pharmaceutical, Daiichi Sankyo, Janssen Pharmaceutical, MSD, ONO Pharmaceutical, and Takeda. Payment for lectures, presentations, and speakers bureaus: AstraZeneca, Boehringer Ingelheim, Chugai Pharmaceutical, Eli Lilly, MSD, Nippon Kayaku, Novartis, ONO Pharmaceutical, and TAIHO. Yasuo Iwamoto: Grants: none. Payment for lectures, presentations, speakers bureaus: none. Yuki Sato: Grants: none. Payment for lectures, presentations, and speakers bureaus: AstraZeneca, MSD, Novartis, Chugai Pharmaceutical, Ono Pharmaceutical, Pfizer, Taiho Pharmaceutical, Nippon Kayaku, Bristol Myers Squibb, Eli Lilly, Takeda, and Kyowa Kirin. Norihiko Ikeda: Grants: Astra Zeneca, Chugai Pharmaceutical, Boehringer Ingelheim, Taiho, Eli Lilly, Ono Pharmaceutical, Bristol-Myers Squibb, MSD, Nihon Mediphysics, Teizin Pharma, Kyowa Hakko Kirin, Sanofi, Eizai, Astellas, Shionogi, Daiichi-Sankyo, and Roche Diagnostic. Payment for lectures, presentations, and speakers bureaus: Astra Zeneca, Chugai Pharmaceutical, Boehringer Ingelheim, Taiho, Eli Lilly, Ono Pharmaceutical, Bristol Myers Squibb, Olympus, MSD, Johnson & Johnson, Nihon Mediphysics, Medtronics, and Teijin Pharma. Toshiaki Takahashi: Grants: AstraZeneca, Chugai Pharmaceutical, Eli Lilly, ONO Pharmaceutical, MSD, Pfizer, Amgen, Boehringer Ingelheim, and Merck Biopharma. Payment for lectures, presentations, and speakers bureaus: AstraZeneca, Chugai Pharmaceutical, Eli Lilly, ONO Pharmaceutical, MSD, Pfizer, Boehringer Ingelheim, Roche Diagnostics, Takeda, and Yakult Honsha. Haruko Daga: Grants: none. Payment for lectures, presentations, and speakers bureaus: Chugai pharmaceutical, Eli Lilly, and Astra Zeneca. Tetsuya Oguri: Grants: none. Payment for lectures, presentations, and speakers bureaus: Chugai pharmaceutical, Astra Zeneca, Ono Pharmaceutical, and Taiho. Yasuhito Fujisaka: Grants: none. Payment for lectures, presentations, and speakers bureaus: Chugai Pharmaceutical, AstraZeneca, Boehringer Ingelheim, Pfizer, Ono Pharmaceutical, Bristol Myers Squibb, Eli Lilly, and MSD. Kazumi Nishino: Grants: AstraZeneca, Chugai pharmaceutical, ONO Pharmaceutical, TAIHO, MSD, AbbVie, DAIICHI SANKYO, Amgen, Eisai, Eli Lilly, Boehringer Ingelheim, Pfizer, Takeda, Merck, Janssen Pharmaceutical, and Bristol Myers Squibb. Payment for lectures, presentations, and speakers bureaus: Eli Lilly, Boehringer Ingelheim, Novartis, Pfizer, Takeda, Merck, Janssen Pharmaceutical, Bristol Myers Squibb, and Nippon Kayaku. Shunichi Sugawara: Grants: none. Payment for lectures, presentations, speakers bureaus: AstraZeneca, Chugai Pharmaceutical, Ono Pharmaceutical, Bristol-Myers Squibb, MSD, Boehringer Ingelheim, Pfizer, Taiho, Eli Lilly, Novartis, Kyowa Kirin, Yakult Honsha, Takeda, Nippon Kayaku, Merck, Amgen, AbbVie, Otsuka, Therrmo Fisher Scientific, and TOWA Pharmaceutical. Toshiyuki Kozuki: Grants: Chugai Pharmaceutical, AstraZeneca, Eli Lilly, Taiho, Bristol-Myers Squibb, Ono Pharmaceutical, MSD, Kyowa Hakko Kirin, Merck Biopharma, Daiichi-Sankyo, Amgen, AbbVie, Sanofi, Eisai, and Labcorp Development Japan. Consulting fees: Chugai Pharmaceutical, AstraZeneca, Ono Pharmaceutical, Pfizer, Daiichi-Sankyo, Bayer, and AbbVie. Payment for lectures, presentations, and speakers bureaus: Chugai Pharmaceutical, AstraZeneca, Eli Lilly, Taiho, Bristol-Myers Squibb, Ono Pharmaceutical, MSD, Pfizer, Kyowa Hakko Kirin, Boehringer Ingelheim, Merck Biopharma, Nippon Kayaku, Novartis, Daiichi-Sankyo, Takeda, Bayer, and Sawai. Masahide Oki: Grants: MSD, Parexel International Corporation, Janssen Pharmaceutical, and Sanofi. Payment for lectures, presentations, and speakers bureaus: none. Nobuyuki Yamamoto: Grants: MSD, AstraZeneca, ONO PHARMACEUTICAL, DAIICHI SANKYO, TAIHO, Takeda, Chugai Pharmaceutical, Pfizer, Amgen, Janssen Pharmaceutical, Toppan printing, Terumo, Boehringer-Ingelheim Consulting fees: AstraZeneca, DAIICHI SANKYO, TAIHO, Takeda, Chugai Pharmaceutical, Eli Lilly, Boehringer-Ingelheim, Novartis, Bristol-Myers Squibb, NIPPON KAYAKU, Life Technologies Japan, Amgen, Guardant Health Japan, and Janssen Pharmaceutical. Payment for lectures, presentations, and speakers bureaus: MSD, AstraZeneca, ONO Pharmaceutical, Thermo Fisher Scientific, DAIICHI SANKYO, TAIHO, Takeda, Chugai Pharmaceutical, Eli Lilly, Boehringer-Ingelheim, Novartis, Pfizer, Bristol-Myers Squibb, NIPPON KAYAKU, GlaxoSmithKline, Sanofi, Hisamitsu Pharmaceutical, and Merk Biopharma. Kazuhiko Nakagawa: Grants: AstraZeneca, MSD, Ono Pharmaceutical, Boehringer Ingelheim, Novartis, Pfizer, Bristol Myers Squibb, Eli Lilly, Chugai Pharmaceutical, Daiichi Sankyo, Merck Biopharma, PAREXEL International. PRA HEALTHSCIENCES, EPS, Kissei Pharmaceutica, EPS International, Taiho, PPD-SNBL, SymBio Pharmaceuticals, IQVIA Services, SYNEOS HEALTH CLINICAL, Nippon Kayaku, EP-CRSU, Mebix, Janssen Pharmaceutical, AbbVie, Bayer Yakuhin, Eisai, Mochida Pharmaceutical, Covance, Japan Clinical Research Operations, Takeda, GlaxoSmithKline, Sanofi, Sysmex, Medical Research Support, Otsuka Pharmaceutical, SRL, Pfizer, R&D Japan G.K., and Amgen. Consulting fees: Eli Lilly, KYORIN Pharmaceutical, Ono Pharmaceutical, Pfizer Payment for lectures, presentations, vspeakers bureaus: Ono Pharmaceutica, Amgen, Nippon Kayaku, AstraZeneca, Chugai Pharmaceutical, Eli Lilly, MSD, Pfizer, Boehringer Ingelheim, and Taiho.

: Written informed consent was obtained from all patients before enrollment. The trial protocol and all amendments were approved by an institutional review board or independent ethics committee at each study site, and the trial was conducted according to Good Clinical Practice guidelines and the Declaration of Helsinki. This study was registered with the University Hospital Medical Information Network in Japan (number 000002014).