Ethics approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards, and all procedures were implemented as a specified clinical trial in accordance with the Clinical Trials Act enacted in April 2018 in Japan. The study was approved by the Clinical Research Review Board of Nagasaki University on 28 April 2020 (#CRB7180001).