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All patients or their legally authorized representatives provided written, informed consent before randomization.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval and Consent to Participate"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of Data and Material"}},{"value":"Dr. Shinichiro Ueda reports research grants from Bristol-Myers Squibb and Kowa; non-purpose research grants from Bristol-Myers Squibb, Chugai, MSD, Pfizer, and Takeda; lecturer\u2019s fees from Boehringer Ingelheim and MSD. Dr. Michio Shimabukuro reports research grants from AstraZeneca, Ono, and Sanwa Kagaku Kenkyusho; non-purpose research grants from Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Chugai, Eli Lilly, Kowa, Mitsubishi Tanabe, MSD, Novo Nordisk, Ono, Taisho Toyama, and Takeda; lecturer\u2019s fees from Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Chugai, Eli Lilly, Kowa, Mitsubishi Tanabe, Mochida, MSD, Novo Nordisk, Ono, Taisho Toyama, and Takeda; advisory board for Novo Nordisk; sponsored office from Boehringer Ingelheim. Dr. Osamu Arasaki reports lecturer\u2019s fees from Abbott, Astellas, Boehringer Ingelheim, Medtronic, and St. Jude Medical. Dr. Koichi Node reports research grants from Abbott, Actelion, Air Water, Asahi Kasei, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Mebix, Mitsubishi Tanabe, Nippon Sigmax, and Teijin; non-purpose research grants from Abbott, Astellas, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly, Kissei, Kowa, Kyowa Hakko Kirin, Medtronic, Mitsubishi Tanabe, MSD, Nippon Shinyaku, Novartis, Otsuka, Pfizer, Sanofi, Sanwa Kagaku Kenkyusho, Sumitomo Dainippon, Takeda, and Teijin; lecturer\u2019s fees from Abbott, Actelion, AnGes, Astellas, Astellas Amgen Bio Pharma, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Eisai, Eli Lilly, Fukuda Denshi, Fukuda Life Tech Kyusyu, Kissei, Kowa, Kyowa Hakko Kirin, Medtronic, Mitsubishi Tanabe, Mochida, MSD, Nippon Kayaku, Nippon Shinyaku, Novartis, Omron, Ono, Otsuka, Pfizer, Roche Diagnostics, Sanofi, Sanwa Kagaku Kenkyusho, Shionogi, Sumitomo Dainippon, Taisho Toyama, Takeda, Teijin, and Toa Eiyo; manuscript fee from Takeda; advisory boards for Astellas, AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD, Novo Nordisk, Pfizer, Sanofi, Shionogi, and Takeda. Dr. Takashi Nomiyama reports research grants from Eli Lilly, Mitsubishi Tanabe, MSD, and Novartis; lecturer\u2019s fees from Arkray, Astellas, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Johnson & Johnson, Mitsubishi Tanabe, MSD, Novartis, Novo Nordisk, Ono, Sanofi, Sanwa Kagaku Kenkyusho, Sumitomo Dainippon, Taisho Toyama, Takeda, and Terumo. Dr. Takeshi Morimoto reports a research grant from Nexis; lecturer\u2019s fees from AbbVie, AstraZeneca, Daiichi Sankyo, Kyorin, Mitsubishi Tanabe, and Pfizer; manuscript fee from Pfizer; advisory boards for Asahi Kasei, Boston Scientific, and Bristol-Myers Squibb.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interests"}},{"value":"The access to the final trial dataset is rigidly restricted to investigators who are authorized by the steering committee and any activity is recorded. There are contractual agreements that limit such access for investigators.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Access to Data"}},{"value":"Confidentiality in the collection of personal information is protected in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects in Japan","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Confidentiality"}},{"value":"The compensation to those who suffer death or severe damage requiring hospitalization from trial participation is provided from the clinical trial insurance organized by the trial sponsor (University of the Ryukyus).","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compensation"}},{"value":"Results from this trial are disseminated through publications and conference presentations to participants, healthcare professionals, and the public.","order":10,"name":"Ethics","group":{"name":"EthicsHeading","label":"Dissemination Policy"}}]}}