2.1. Trial Design and Ethics Statements
MAY
This trial was a randomized, controlled, open-label study conducted in Shanghai Tenth People’s Hospital between May 2021 and May 2022. The study protocol was approved by the Ethics Committee of Shanghai Tenth People’s Hospital (approval number SHSY-IEC-4.1/21-119/01), and the clinical trial registration number was NCT04876027. Written informed consent was acquired by each subject.