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Haruyasu Murakami has received honoraria from AstraZeneca and has received research funding from Astellas, AstraZeneca, Eli Lilly, and Taiho Pharmaceutical. Takashi Seto has received honoraria from AstraZeneca, Chugai Pharmaceutical, Eli Lilly Japan, Nippon Boehringer Ingelheim, Ono Pharmaceutical, Pfizer Japan, Taiho Pharmaceutical, and Merck Sharp & Dohme, and has received grants from Astellas Pharma, AstraZeneca, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Eisai, Kissei Pharmaceutical, Merck Serono, Merck Sharp & Dohme, Nippon Boehringer Ingelheim, Novartis, Pfizer Japan, Verastem, and Yakult Honsha. Toshio Shimizu has received research funds from Bristol-Myers Squibb, Daiichi Sankyo, Takeda-Millennium, Five Prime, PharmaMar, 3D Medicine, and SymBio Pharmaceuticals. Shigeru Takeshita, Kentaro Takeda, and Erkut Bahceci are employees of Astellas Pharma Global Development, Inc. Junko Toyoshima, Itsuro Nagase, and Maiko Morishita are employees of Astellas Pharma Inc. Satoshi Morita has received honoraria from AstraZeneca, Chugai, Bristol-Myers Squibb, and Eli Lilly, and has received research funds from Boehringer Ingelheim. Masahiro Fukuoka has received honoraria from Astellas Pharma Inc. Kazuhiko Nakagawa has received honoraria from Eli Lilly Japan K.K., AstraZeneca K.K., Pfizer Japan Inc., Astellas Pharma Inc., Nippon Boehringer Ingelheim Co., Ltd., MSD K.K., and Ono Pharmaceutical Co., Ltd. and has received research funds from MSD K.K., Quintiles Inc., Eisai Co., Ltd., Daiichi Sankyo Co., Ltd., AbbVie Inc., ICON Japan K.K., Eli Lilly Japan K.K., Bristol-Myers Squibb Company, Ono Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., A2 Healthcare Corp., Astellas Pharma Inc., inVentiv Health Japan, AC Medical Inc., Gritstone Oncology Inc., Nippon Boehringer Ingelheim Co., Ltd., Takeda Pharmaceutical Co., Ltd., and Chugai Pharmaceutical Co., Ltd. Sawori Watanabe declares no conflict of interest. This study was sponsored by Astellas Pharma Inc (APGD Japan).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was approved by the ethical review board of the participating institutions and posted on ClinicalTrials.gov under the identifier NCT01401504. All study procedures were conducted in accordance with the principles of the Declaration of Helsinki.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All patients provided informed consent to participate in the study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Datasets from this study have not been made available in an open data repository.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Akira Ono, Haruyasu Murakami, Toshio Shimizu, Takashi Seto, Sawori Watanabe and Kazuhiko Nakagawa substantially contributed to the acquisition and interpretation of data, as well as drafting and critically revising the manuscript. Masahiro Fukuoka, Satoshi Morita, Shigeru Takeshita, Kentaro Takeda, Junko Toyoshima, Itsuro Nagase, Erkut Bahceci and Maiko Morishita substantially contributed to the study design, and the analysis and interpretation of data, as well as drafting and critically revising the manuscript. All authors approved the final version to be published and agree to be accountable for all aspects of the work.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 contributions"}}]}}