Ethical considerations
disability or dysfunction
ADVERSE EVENTS, ADVERSE EVENT, MINOR, ADVERSE EVENT, EVENTS
The study was approved by the Institutional Research Ethics Board at Osaka University Hospital (No. 14372). The study was explained orally and in an attached patient information sheet, and consent was obtained in writing. The consent was obtained after stating in the explanation document that participation in the study is voluntary, that no disadvantages will be incurred if the patient does not agree to participate, and that the patient has the right to withdraw the consent obtained for the study at any time without any disadvantages. For minor patients, consent was obtained from the patients themselves and their parents or guardians. This clinical research was conducted in compliance with the Ethical Guidelines for Clinical Research (Ministry of Health, Labor, and Welfare) and the Declaration of Helsinki (World Medical Association). Adverse events were defined as events deemed by the physician to be harmful regardless of whether or not they are causally related to the protocol treatment and the following were treated as serious adverse events.Those resulting in deathLife-threateningThose that result in permanent or marked disability or dysfunction.In the case of a serious adverse event, the head of the facility and the principal investigator were notified immediately. When handling data related to the study, due consideration will be given to protect the confidentiality of the subjects.