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Ltd, Ono Pharmaceutical Co. Ltd, Otsuka Pharmaceutical Co. Ltd, Novartis Pharma K.K., and Takeda Pharmaceuticals Co. Ltd; has performed corporate-sponsored research for Takeda Pharmaceutical Co. Ltd; has received honoraria from GlaxoSmithKline K.K., Nippon Boehringer Ingelheim Co. Ltd, FP Pharmaceutical Corporation, Sumitomo Dainippon Pharma Co. Ltd, Eisai Co. Ltd, Kissei Pharmaceutical Company, Nihon Medi-physics Co. Ltd, Kyowa Hakko-Kirin Co. Ltd, Novartis Pharma K.K, Biogen Japan Ltd, Acorda Therapeutics Inc., Otsuka Pharmaceutical Co. Ltd, Janssen Pharmaceutical K.K, Medtronic Japan Co. Ltd, Astellas Pharma Inc.; has received donations from Astellas Pharma Inc., Eisai Co. Ltd, MSD K.K., Daiichi Sankyo Co. Ltd, Novartis Pharma K.K., Takeda Pharmaceutical Co. Ltd, Nihon Medi-physics Co. Ltd, Sumitomo Dainippon Pharma Co. Ltd, Pfizer Japan Inc., Bayer Yakuhin Ltd, FP Pharmaceutical Corporation, Shionogi & Co. Ltd, MSD; and has received donations for the endowed research departments GlaxoSmithKline K.K., Nippon Boehringer Ingelheim, Co. Ltd, Sumitomo Dainippon Pharma Co. Ltd, Eisai Co. Ltd, Kissei Pharmaceutical Co., Nihon Medi-physics Co. Ltd, Kyowa Hakko-Kirin Co. Ltd, Medtronic Japan Co. Ltd, Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd, Mitsubishi Tanabe Pharma Co., Zaiho Co. Ltd, Asahi Kasei Medical Co. Ltd, MiZ Co. Ltd. Atsushi Takeda has served on advisory boards for AbbVie Inc., Kyowa Hakko-Kirin Co. Ltd, and Takeda Pharmaceutical Co. Ltd; has performed corporate-sponsored research for Hisamitsu Pharma Co. Inc., Meiji-Seika Pharma Co. Ltd, Pfizer Japan Inc.; and has received honoraria from AbbVie Inc., Sumitomo Dainippon Pharma Co. Ltd, Kyowa Hakko-Kirin Co. Ltd. Shinichi Takeda, Akira Nishimura, and Ryou Nakaya are employees of Takeda Pharmaceutical Co. Ltd. Hideki Mochizuki has served on advisory boards for Hisamitsu Pharmaceutical Co., Inc., Takeda Pharmaceutical Co. Ltd; has received honoraria from FP Pharmaceutical Corporation, Sumitomo Dainippon Pharma Co. Ltd, Nihon Medi-physics Co. Ltd, Kyowa Hakko-Kirin Co. Ltd, Novartis Pharma K.K., Otsuka Pharmaceutical Co. Ltd; has received donations from Nihon Medi-physics Co. Ltd, Sumitomo Dainippon Pharma Co. Ltd, Kyowa Hakko-Kirin Co. Ltd. Masahiro Nagai has served on an advisory board for Takeda Pharmaceuticals Co. Ltd; and has received honoraria from Novartis Pharma K.K. Ryosuke Takahashi is an employee of the Japan Agency for Medical Research and Development; has served on advisory boards for Kan Institute Co. Ltd and Sumitomo Dainippon Pharma Co. Ltd; has performed corporate-sponsored research for Novartis Pharma K.K. Co., Otsuka Pharmaceutical Co. Ltd, Pfizer Japan Inc., Takeda Pharmaceuticals Co. Ltd, Nippon Boehringer Ingelheim Co. Ltd, Sumitomo Dainippon Pharma Co. Ltd, Kyowa Hakko-Kirin Co. Ltd, Nihon Medi-Physics Co. Ltd, Mitsubishi Tanabe Pharma Co. and Konica Minolta Inc.; and has received honoraria from Sumitomo Dainippon Pharma Co Ltd., and FP Pharmaceutical Co.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was conducted with the highest respect for the study participants according to the protocol and the ethical principles that have their origin in the Declaration of Helsinki. The study was reviewed and approved by the Institutional Review Board at each of the participating study centers, and was conducted in full compliance with the International Conference on Harmonization unified guidelines and the regulatory requirements of the region.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Research involving human participants"}},{"value":"This study was conducted in compliance with the regulations for consent as set forth in the Guidelines and Ordinance on Good Clinical Practice (GCP). All patients provided written, informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}