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Yuji Kumagai, Michio Yagi, Takashi Eto, Rie Yazawa, and Makoto Yono have no conflicts of interest to declare.","order":1,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This randomized, double-blind, single-dose study was conducted between April 11, 2022 and November 22, 2022 at four institutions in Japan. The study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, and the appropriate regulatory requirements in the countries in which the study was conducted. The protocol, its amendments, and informed consent documentation were reviewed and approved by the institutional review board at the site. All participants provided written informed consent prior to any study-specific procedures. This study is registered with the Japan Registry of Clinical Trials (number, jRCT2071210135; date of registration, March 22, 2022).","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}