[Details of Ethics Approval]
This study was approved initially by the Kyushu University Institutional
Review Board for Clinical Trials, Fukuoka, Japan, Aug. 5, 2016 (Trial
ID: UMIN000023161). However, the Clinical Trials Act came into force in
Japan, April 2018. By the new act, all clinical trials which correspond
to the legal requirements have been required to be registered to the new
official database “jRCT”. Therefore, this study was reviewed again and
approved by the Kyushu University Certified Institutional Review Board
for Clinical Trials which has been established by the new act, March 29,
2019 (Trial ID: jRCTs071180085).