Ethical approval
for this study (ethics: KY-20211130002-02) was provided by the Ethics Committee of the affiliated Lianyungang Hospital of Xuzhou Medical University, Lianyungang, China on 29 January 2022. The trial was registered in the Chinese Clinical Trial Registry (ChiCTR2200056624) on 09/02/2022 before enrollment. The study protocol followed the CONSORT guidelines. All participants signed written informed consent.