4. Trial status
RECRUITMENT
The study was approved on December 22, 2020. Participant recruitment will begin on July 8, 2021. The expected date of completion is the end of December 2024. Central ethical approval was obtained from the Hiroshima University Certified Review Board (reference approval number: CRB6180006). The protocol and progress have been registered in Japan Registry of Clinical Trials (jRCT), jRCTs061210021 since July 8, 2022. Protocol version is v1.3 as on February, 2022.