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Atsumi reports personal fees from Chugai, during the conduct of the study; grants and personal fees from Astellas, grants and personal fees from Takeda, grants and personal fees from Mitsubishi Tanabe, grants and personal fees from Chugai, grants and personal fees from Pfizer, grants from Daiichi Sankyo, grants from Otsuka, personal fees from Eisai, personal fees from AbbVie, outside the submitted work. S. Yasuda reports grants and speaker\u2019s fee from Bristol-Myers Squibb Co., Speaker\u2019s fee from Chugai, Mitsubishi Tanabe, outside the submitted work. M. Kato reports grants from GSK, grants from Actelion, outside the submitted work. The other authors state that they have no conflict of interest. M. Takahata reports grants and speaker\u2019s fee from Chugai, Eisai, DePuy Spine Inc, and Medtronic, outside the submitted work. The other authors state that they have no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was performed in accordance with the Declaration of Helsinki and the principles of Good Clinical Practice. Study approval was obtained from the Local Ethics Committee (approval number: 017-0029).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}