Ethics approval and consent to particiate
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. Written informed consent was obtained from all participants. The trial was registered in the Chinese Clinical Trial Registry (ChiCTR2200056624) on 09/02/ 2022 before enrollment. All methods were performed in accordance with the Declaration of Helsinki.