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Article History

Received: 17 July 2025

Accepted: 5 September 2025

First Online: 4 November 2025

Declarations

:

: According to the WMA Helsinki Declaration, CIOMS International Ethical Guidelines for Biomedical Research on the Human Body, the original CFDA Guidelines for Ethical Review of Drug Clinical Trials (2010), the Medical Device Clinical Trial Management Regulations (2016), the People’s Republic of China Health Commission’s Ethical Review Measures for Biomedical Research Involving Human Subjects (2016), and NMPA’s Good Clinical Practice (2020), after review by IEC for Clinical Research of Zhongda Hospital, Affiliated to Southeast University, it is agreed to conduct study 2020ZDSYLL218-PO1 according to the approved project design document.

: Written publication consent for personal and clinical details along with identifying images in this study has been obtained from all patients.

: The authors have no conflicts of interest to declare.