Study design and ethics

MH Mariko Hakoshima
KK Kazuya Kitakaze
HA Hiroki Adachi
HK Hisayuki Katsuyama
HY Hidekatsu Yanai
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Research design is a retrospective observational study. Informed consent was obtained by the opt-out approach. The study protocol was approved by the Ethics Committee of the National Center for Global Health and Medicine (NCGM-S-004344-00), and the study was performed in accordance with the Declaration of Helsinki.

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