Document is current

Article History

Received: 12 December 2019

Accepted: 16 December 2020

First Online: 7 January 2021

Ethics approval and consent to participate

: All procedures performed on human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The institutional review boards at each of the 31 study sites approved the study protocol. Ethical committee’s name and reference number is Institutional Review Board for Clinical Research, Tokai University and 14R-063. Informed, written consent was obtained from all individual participants included in the study.

: Not applicable.

: Naoki Niikura has received research funding from Tokai University, Novartis, Bristol-Myers Squibb, Chugai Pharmaceutical Co, Nihon Medi-Physics Co. Ltd. MSD, and Daiichi-Sankyo and honoraria, consultancy, and speaker fees from AstraZeneca, Novartis, Eisai, and Pfizer outside the submitted work. Toshinari Yamashita has received research grants and honoraria from Novartis, AstraZeneca, Eisai, Chugai, Taiho, Kyowa Kirin Pharma, Pfizer, and Eli Lilly. Takashi Yamanaka has received lecture fees from Novartis, Eisai, Chugai, Taiho, and Pfizer. Naoki Hayashi reports personal fees from Chugai, Novartis, AstraZeneca, Pfizer, Kyowa Kirin Pharma, Genomic Health Inc., Devicor Japan, and Allergan Japan for the submitted work. Hirofumi Mukai received entity from the Japanese government; honoraria from AstraZeneca, Pfizer, and Taiho; and grants from Daiichi Sankyo, Eisai, Nippon Kayaku, and Pfizer outside the submitted work. The other authors declare no competing interests.