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Correct version is presented here.","order":6,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Written informed consent was obtained from all patients prior to participation. Ethical approval was provided by the Institutional Review Board at each participating site.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with ethical standards"}},{"value":"Specific and substantive relationships are as follows: Mitsukuni Murasaki declares personal fees from Astellas Pharma Inc., Meiji Seika Pharma Co., Ltd., Eli Lilly Japan, Eisai Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Pfizer Inc., and Janssen Pharmaceutical K.K. Tsukasa Koyama declares personal fees from Astellas Pharma Inc., Eli Lilly Japan, Otsuka Pharmaceutical Co., Ltd., and Mitsubishi Tanabe Pharma Co. Shigenobu Kanba declares honoraria from MSD K.K., Astellas Pharma Inc., Mochida Pharmaceutical Co., Ltd., Eisai Co., Ltd., Takeda Pharmaceutical Co., Ltd., Dainippon-Sumitomo Pharma Co. Ltd., Otsuka Pharmaceutical Co., Ltd., Taisho-Toyama Pharmaceutical Co. Ltd., Janssen Pharmaceutical K.K., Meiji Seika Pharma Co. Ltd., Yoshitomiyakuhin Co., Nippon Chemiphar Co. Ltd., Daiichi Sankyo Co. Ltd., Pfizer Inc., Shionogi & Co., Ltd., and Mitsubishi Tanabe Pharma Co., and research funding from Dainippon-Sumitomo Pharma Co. Ltd., Janssen Pharmaceutical K.K., Astellas Pharma Inc., Nippon Chemiphar Co. Ltd., Pfizer Inc., Mochida Pharmaceutical Co. Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Meiji Seika Pharma Co., Ltd., Yoshitomiyakuhin Co., and Shionogi & Co., Ltd. Masahiro Takeuchi (takeuchim@pharm.kitasato-u.ac.jp) declares personal fees from Astellas Pharma Inc. Yuriko Shimizu, Eri Arita, Kentaro Kuroishi, Masahiro Takeuchi, and Shinya Kamei are employees of Astellas Pharma Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was conducted in adherence to the ethical principles that are based on the Declaration of Helsinki, Good Clinical Practice, guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, and applicable laws and regulations.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Research involving human participants"}},{"value":"The institutional review board (IRB) of each study site reviewed and approved the protocol, case report form, written information, and informed consent form. The informed consent of patients was obtained using the written information and informed consent form approved by the IRB of each study site prior to the start of any study-related procedures.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}