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Kazuo Fujihara is an Editorial Board member of\n                      Neurology and Therapy\n                      . Kazuo Fujihara was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Shinya Hirota, Hideaki Hida, Kyoko Kato, Muneyoshi Kudo, Satoshi Yuki, and Takashi Narisawa are employees of Tanabe Pharma Corporation.","order":1,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This PMS has been mandated by the Ministry of Health, Labour and Welfare of Japan and\u00a0is being conducted in compliance with the Good Post-marketing Study Practice (GPSP) ordinance and the principles of the Declaration of Helsinki (1964) and its later amendments. The study protocol was approved through pre-consultation with the Pharmaceuticals and Medical Devices Agency (PMDA), in accordance with the GPSP. 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