Ishikawa, Eri
Takahashi, Yasuhiro http://orcid.org/0000-0002-1363-2870
Valencia, Ma. Regina Paula
Ana-Magadia, Marian Grace
Kakizaki, Hirohiko
Article History
Received: 6 August 2018
Revised: 12 November 2018
Accepted: 20 November 2018
First Online: 28 November 2018
Compliance with ethical standards
:
: The authors have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.
: The institutional review board (IRB) of Aichi Medical University Hospital approved this retrospective, observational study (no. 17-H053); in addition, the study was conducted in accordance with the tenets of the Declaration of Helsinki and its later amendments. The IRB granted a waiver of informed consent for this study based on the ethical guidelines for medical and health research involving human subjects established by the Japanese Ministry of Education, Culture, Sports, Science, and Technology; and by the Ministry of Health, Labour, and Welfare. The waiver was granted because the study was a retrospective chart review, not an interventional study, and because it was difficult to obtain consent from patients who had been treated several years previously. Nevertheless, at the request of the IRB, we published an outline of the study on the Aichi Medical University website that was available for public viewing; this also gave patients the opportunity to refuse to participate in the study, although none did. Personal identifiers were removed from the records prior to data analysis.