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Zhihong Cai and Tomotaka Shingaki are employees of Eli Lilly Japan K.K. and shareholders in Eli Lilly and Company. Masahiko Takai is a board member of the Kanagawa Prefecture Medical Association. Shintaro Suo, Ryohei Takeda, and Kanako Shimoura are employees of Mebix, Inc., to whom performing the study was outsourced by Eli Lilly Japan K.K. Yasushi Fukushima, Toshiyuki Takahashi, and Hirotaka Nagashima have no competing interests to disclose. Manaka Sato is a shareholder of Eli Lilly and Company and contributed to this work as a former full-time employee of Eli Lilly Japan K.K. The opinions expressed in this work were solely her own and do not represent those of her current affiliation, Nippon Boehriger Ingelheim Co., Ltd.","order":1,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was approved by Takahashi Clinic Ethics Committee (LNW00210); this approval covered the necessary ethics approvals for all five study sites. This study was conducted in accordance with the ethical principles described in the Declaration of Helsinki and the Ethical Guidelines for Medical and Biological Research Involving Human Subjects and Japanese laws and regulations.","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}