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Article History

Received: 10 May 2020

Accepted: 25 November 2020

First Online: 4 December 2020

Ethics approval and consent to participate

: This study was approved by the institutional review board at each site. The ethics committees are review boards of Oita Prefectural Hospital, Japan Community Health care Organization Isahaya General Hospital, Kumamoto University Hospital, National Hospital Organization Kyushu Cancer Center, National Hospital Organization Omuta Hospital, Kyushu University Hospital, Nagasaki Prefecture Shimabara Hospital and Oita University. Patients decided whether or not they would participate in the trial after being given a detailed explanation, and written informed consent was obtained from all patients prior to enrolment. All procedures performed in studies were in accordance with the 1964 Helsinki declaration and tis later amendment. This study also adheres to CONSORT guidelines.

: Not applicable.

: Mitsuhiro Takenoyama received honoraria from AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Covidien Japan, Eli Lilly Japan, Kyowa Hakko Kirin, MSD, Nippon Boehringer Ingelheim, Novartis Pharma, Ono Pharmaceutical, Pfizer Japan and Taiho Pharmaceutical. He also received research funding from AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Covidien Japan, Eli Lilly Japan, Johnson & Johnson, Kyowa Hakko Kirin, KM biologics, MSD, Nippon Boehringer Ingelheim, Novartis Pharma, Ono Pharmaceutical and Taiho Pharmaceutical. Kenji Sugio received research funding from MSD.