Fujiwara, Yutaka
Yamazaki, Naoya
Kiyohara, Yoshio
Yoshikawa, Shusuke
Yamamoto, Noboru
Tsutsumida, Arata
Nokihara, Hiroshi
Namikawa, Kenjiro
Mukaiyama, Akihira
Zhang, Fanghong
Tamura, Tomohide
Funding for this research was provided by:
GlaxoSmithKline
Article History
Received: 12 July 2017
Accepted: 11 August 2017
First Online: 7 September 2017
Compliance with ethical standards
:
: Y Fujiwara reports grants from AstraZeneca, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, GlaxoSmithKline, Merck Serono, MSD and Novartis; and honoraria and personal fees from Bristol-Myers Squibb and ONO. N Yamazaki reports personal fees from ONO, Takeda, Bristol-Myers Squibb, Chugai, Boehringer Ingelheim and research funding from ONO, Bristol-Myers Squibb and Novartis Pharma K.K. Y Kiyohara reports personal fees from ONO, Chugai, Bristol-Myers Squibb and grants from Chugai and MSD. N Yamamoto reports grants from Chugai,Taiho, Eisai, Eli Lilly, Quintiles, Astellas, BMS, Novartis, Daiichi-Sankyo, Pfizer,Boehringer Ingelheim, Kyowa-Hakko Kirin, Bayer, ONO and Takeda and other support from Chugai, Astrazeneca, Eli Lilly and BMS. H Nokihara reports grants from Merck Serono, Pfizer, Novartis, Daiichi Sankyo, GlaxoSmithKline and Quintiles and personal fees from Taiho Pharmaceuticals, Eisai, Chugai, Eli Lilly, AstraZeneca, Boehringer-Ingelheim,ONO, Sanofi and Bristol-Myers Squibb. K Namikawa reports personal fees from ONO, Bristol-Myers Squibb, Merck Sharp and Dohme, Toray Industries, Chugai and Novartis Pharmaceuticals. T Tamura reports personal fees from Chugai, Taiho, Eisai, Yakult, Eli Lilly, Boehringer-Ingelheim, Bristol-Myers Squibb, ONO and Kyowa Kirin. A Mukaiyama and F Zhang are employees of Novartis Pharma K.K., Japan. S Yoshikawa, and A Tsutsumida have nothing to disclose.
: All procedures performed in the study were conducted in accordance with the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (GCP) and the Declaration of Helsinki. All protocols and amendments were approved by the independent ethics committee or institutional review board for each study center. All patients provided written informed consent before participating in any study procedures.