Suzuki, Fumitaka
Suzuki, Yoshiyuki
Karino, Yoshiyasu
Tanaka, Yasuhito
Kurosaki, Masayuki
Yatsuhashi, Hiroshi
Atarashi, Tomofumi
Atsukawa, Masanori
Watanabe, Tsunamasa
Enomoto, Masaru
Kudo, Masatoshi
Maeda, Naoto
Kohno, Hiroshi
Joko, Kouji
Michitaka, Kojiro
Miki, Koichiro
Takahashi, Kazuhiro
Ide, Tatsuya
Fujiyama, Shigetoshi
Kohno, Tomoko
Itoh, Hiroshi
Tsukamoto, Sakiyo
Suzuki, Yuko
Kawano, Yoshiaki http://orcid.org/0000-0002-2305-1711
Sugiura, Wataru
Kumada, Hiromitsu
Funding for this research was provided by:
GlaxoSmithKline
Article History
Received: 22 December 2020
Accepted: 2 November 2021
First Online: 20 December 2021
Declarations
:
: The study was approved by the ethics committee at every participating institution (Ehime Prefectural Central Hospital IRB, Ehime, Japan; Kindai University Hospital IRB, Osaka, Japan; Kitakyushu Municipal Medical Center IRB, Fukuoka, Japan; KKR Clinical Trial Network Central Institutional Review Board, Tokyo, Japan; Kumamotoshinto General Hospital IRB, Kumamoto, Japan; Kurume University Hospital IRB, Fukuoka, Japan; Matsuyama Red Cross Hospital IRB, Ehime, Japan; Musashino Red Cross Hospital IRB, Tokyo, Japan; Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board, Aichi, Japan; National Hospital Organization Kure Medical Center and Chugoku Cancer Center IRB, Hiroshima, Japan; National Hospital Organization Nagasaki Medical Center IRB, Nagasaki, Japan; Nippon Medical School Chiba Hokusoh hospital IRB, Chiba, Japan; Obihiro-Kosei General Hospital IRB, Hokkaido, Japan; Osaka City University Hospital IRB, Osaka, Japan; Sanin Rosai Hospital IRB, Tottori, Japan; Sapporo-Kosei General Hospital IRB, Hokkaido, Japan; St. Marianna University Group Institutional Review Board, Kanagawa, Japan) and was conducted according to the recommendations of Good Clinical Practice and the Declaration of Helsinki (2013). All participants provided written informed consent to participate in the study. This manuscript was developed following the CONSORT guidelines as much as possible even through this is not a randomized control trial.
: Not Applicable.
: This study (NCT03258710) was conducted with a research fund from GlaxoSmithKline (GSK), in which FS, YS1, YK1, TA, MA, MK1, TW, YT, ME, MK2, NM, HK1, KJ, KM1, KM2, KT, TI, HY, SF, and HK2 participated as investigators and their institutions received funding in relation to this work. FS has served on the advisory board for GSK, and has received personal fees from AbbVie Inc., Bristol Myers Squibb, and GSK; YT has served on several advisory boards for GSK, has received personal fees from Fujirebio Inc., GSK, and Sysmex Corporation, has received personal fees and grants from Gilead Sciences Inc. and grants from FUJIFILM Corporation and Janssen Pharmaceutical KK, and has served on the Board of Trustees of the Leland Stanford Junior University; MK1 and HY have served on the advisory board for GSK, and have received personal fees from GSK; TA has received grants and personal fees from AbbVie Inc.; MA has received grants and personal fees from AbbVie Inc., and Merck Sharp & Dohme (MSD); KJ has received speaking fees from AbbVie Inc., Gilead Sciences, Inc., MSD, and Otsuka Pharmaceutical Co., Ltd.; TK, HI, YS2, and YK2 are employees of and own stock in GSK; ST is employee of GSK; WS is a former employee of GSK; HK2 has served as a speaker and trainer for AbbVie Inc., Eisai Co. Ltd, Gilead Sciences, Inc., MSD KK, and Sumitomo Dainippon Pharma.