Study design and ethics
MAY
This study was designed as a randomized, controlled trial. Ethical approval for this study (approval number 2021PS511K) was provided by the Institutional Review Board of Shengjing Hospital, Shenyang, China (Chairperson Prof Y. Zhao) on 12 May 2021. The trial was registered with the Chinese Clinical Registry Center (registration No. ChiCTR2200056937, dated 23/02/2022) before patient enrollment. This study was conducted in the Shengjing Hospital of China Medical University (Shenyang, China). Written informed consent was obtained from all subjects participating in the trial. The trial protocol is following the Declaration of Helsinki. This manuscript adheres to the applicable CONSORT guidelines.