Trial design
COMPLICATIONS
From November 2019 to November 2020, this randomized, open-label, parallel-group controlled trial was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines, with the clinical trial registration number of ChiCTR1900026336. The present protocol was approved by the Ethics Committee for Clinical Research of the hospital with the number of SFYLS-2020-011. All recruited participants were informed the related risks and complications and signed an informed consent form. Investigators were responsible for data collection and analysis.