Ito, Jun http://orcid.org/0000-0002-7009-5143
Kimura, Moritsugu
Toya, Tomoyuki
Isozumi, Konomi
Kawaji, Atsuro
Isozaki, Yudai
Fukagawa, Masafumi
Article History
Received: 26 August 2021
Accepted: 29 March 2022
First Online: 11 April 2022
Declarations
:
: All procedures performed in the present study involving human participants were in accordance with the ethical standards of the Institutional Review Board of Tokai University School of Medicine (IRB approval number 21R183) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Since the present study is a retrospective observational study using only past clinical data, it does not involve invasion or intervention. Therefore, document or verbal consent from each study subject, excepting six cases reported in detail, is not required. In accordance with “Ethical guidelines for medical and health research involving human subjects (the Ministry of Education, Culture, Sports, Science and Technology / the Ministry of Health, Labour and Welfare in Japan, revised in 2021)”, by posting documents at conspicuous places in the hospital and at website, we notified study subjects of study content so that they could easily understand it, and guaranteed opportunities for them to refuse it (opt out). If there was an offer that they would not want to be a subject of the study, we quickly excluded the subject's data from the analysis and did not use their clinical information in this study. However, for six cases reported in detail, a separate written consent from each case was obtained as described in the following section.
: Written informed consent was obtained in all six cases, who were reported in detail as case presentation in the present study, from the patients and the guardian to publish it.
: The authors declare that they have no competing interests.