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Norihito Kaku received research funding from GSK for this study. Naoki Hosogaya, Kiyoyasu Fukushima, Ryota Takao, and Naoki Iwanaga have nothing to disclose. Takuya Izumikawa has an advisory contract with Japan Lifeline Co., Ltd. Mai Kato is an employee of GSK. Kentaro Tajima and Yufan Ho are employees of and hold financial equities in GSK. Katsunori Yanagihara received speaker fees (honorarium) from GSK, Pfizer Inc., and bioM\u00e9rieux Japan Ltd., and research funding from GSK. Hiroshi Mukae received honorarium from GSK.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was conducted in accordance with the ethical principles derived from the Ethical Guidelines for Medical and Health Research Involving Human Participants; international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines; Food and Drug Administration (FDA) Code of Federal Regulations Title 21; and all applicable regulations and local laws governing research involving human participants. Approval for the study protocol was obtained from the Nagasaki University Hospital Research Ethics Committee (approval number: 23112004). Written informed consent was obtained from all participants prior to enrollment, and participants\u2019 personal data were de-identified to the sponsor and retained under local data protection law and privacy legislation.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}