Study design
This multicenter, randomized, double-blind, positive-controlled trial was initiated by the investigator and approved by the Ethics Committee of Sichuan Provincial People’s Hospital (approval number: 420 of 2021, approval date: September 3, 2021). The authors confirm that all ongoing and related trials for this drug/intervention are registered. This trial was registered in the Clinical Trials Center (registration number: NCT05429086). The study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki. Patients were recruited from July 01, 2022, to September 30, 2022, the last patient’s follow-up was also completed on September 30, 2022. Before beginning enrollment, all investigators received structured education according to the protocol, and quality control officers were assigned to the sub-centers to ensure consistency. Patients provided written informed consent before participation. All study endpoints were collected and analyzed blindly.