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Takashi Ogura has received consulting fees from Boehringer Ingelheim, Bristol-Myers Squibb and Taiho Pharmaceutical Co.; and lecture fees or honoraria from Boehringer Ingelheim, Eisai Inc., Kyorin Pharmaceutical Co., Ltd., Shionogi and Co., Ltd. and Teijin Pharma. Arata Azuma has received consulting fees from Toray Co., Ltd.; lecture fees and participation on an advisory board from Boehringer Ingelheim and Taiho Pharmaceutical Co.; and support for travel from Boehringer Ingelheim. Yasuhiro Kondoh has received consulting fees from Boehringer Ingelheim, Chugai Pharmaceutical Co., Ltd., Healios K.K., Janssen Pharmaceutical K.K., Shionogi and Co., Ltd. and Taiho Pharmaceutical Co.; and payments or honoraria from Boehringer Ingelheim, Bristol-Myers Squibb, Eisai Inc., Janssen Pharmaceutical K.K., Kyorin Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma, Novartis Pharma K.K., Shionogi and Co., Ltd. and Teijin Pharma. Sakae Homma has received consulting fees from Boehringer Ingelheim. Kenya Muraishi and Rie Ikeda are employees of Nippon Boehringer Ingelheim Co., Ltd. Kaori Ochiai is an employee of EPS Corporation and is in charge of analysis work on behalf of Nippon Boehringer Ingelheim Co., Ltd. Yukihiko Sugiyama was on a data safety advisory board from Boehringer Ingelheim. Toshihiro Nukiwa has received consulting fees from Boehringer Ingelheim and payments or honoraria from Grifols.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The study was conducted under the direction of the Ministry of Health, Labour and Welfare (MHLW) and the protocol was approved by the MHLW before its initiation. Participating institutes were contracted by Boehringer Ingelheim. As per the Japanese Pharmaceutical and Medical Device Act, this study was conducted in accordance with the Good Post-marketing Study Practice (GPSP) guidance. 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