Ethics approval and consent to participate
The study was designed as a prospective, single-centre, double-blinded, randomized controlled trial that followed the ethical standards stated in the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. It was approved by the Medical Ethics Committee of the Third Hospital of Hebei Medical University (Approval No. 2021-003-1) and registered at ClinicalTrials.gov (ChiCTR2100050486; principal investigator: Xiaojuan Qie, M.D.; 28/08/2021). All participants provided written informed consent before enrolment.