Fujiwara, Yasuhiro
Mukai, Hirofumi
Saeki, Toshiaki
Ro, Jungsil
Lin, Yung-Chang
Nagai, Shigenori E.
Lee, Keun Seok
Watanabe, Junichiro
Ohtani, Shoichiro
Kim, Sung Bae
Kuroi, Katsumasa
Tsugawa, Koichiro
Tokuda, Yutaka
Iwata, Hiroji
Park, Yeon Hee
Yang, Youngsen
Nambu, Yoshihiro
Article History
Received: 10 August 2018
Revised: 9 January 2019
Accepted: 17 January 2019
First Online: 12 February 2019
Competing interests
: Y.F. reports grants and other from Japan Agency for Medical Research and Development, grants and other from The Ministry of Health Labor and Welfare, Japan, during the conduct of the study; other from Astra Zeneca KK, other from Eisai Co., Ltd, other from Daiichi Sankyo Co., Ltd, other from Taiho Pharmaceutical Co., Ltd, grants from Takeda Pharmaceutical Co., Ltd, grants and other from Chugai Pharmaceutical Co., Ltd, other from Eli Lilly Japan KK, other from Novartis Pharma KK, outside the submitted work. H.M. received honoraria from Nippon Kayaku Co., Ltd. T.S. received honoraria and research funding from Nippon Kayaku Co., Ltd. J.R. received consulting fees from Nippon Kayaku Co., Ltd. Y.-C.L. received consulting fees from Nippon Kayaku Co., Ltd. Y.T. received research funding from Nippon Kayaku Co., Ltd. Y.N. is an executive officer of Nippon Kayaku Co., Ltd. The other authors declare no competing interests.
: The data generated and analysed during this study are available at ClinicalTrials.gov (NCT01644890).
: Written informed consent was obtained from each patient prior to entry into the study. The study was conducted in compliance with the principles of the declaration of Helsinki, the international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use guidelines and local ethical and legal requirements. The protocol and informed consent were approved by the independent ethics committees or institutional review board of all participating sites and regulatory authorities in participating countries.