2.7. Ethics
This study was approved by the Ethics Committee of Juntendo University (approval number 2019043). Participants received written information about the trial, including its aim, expected advantages, and their role, and they were then asked to provide their written, informed consent. This study was retrospectively registered with University Hospital Medical Information Network (UMIN) under ID number UMIN000041435 on 1 September 2020. UMIN is a network member of the Japan Primary Registries Network (JPRN) as described in Primary registries, the WHO registry network. All procedures were performed in accordance with the relevant guidelines and regulations.