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Article History

Received: 29 April 2025

Accepted: 17 September 2025

First Online: 28 September 2025

Declarations

:

: Denny Hou, Shufang Wang, Wei Yao, Gaochong Zhang, Jianmin Chen, Zhengwei Tang, Linda Song, Xingna Zhao, Xiaoxiang Chu, Xiaoyan Wang, and Renshu Li are employed by the funding body of this study; the remaining authors have no conflicts of interest to disclose.

: The study protocol, informed consent form (ICF), and other relevant documents were reviewed and approved by the Independent Ethics Committee of The Second Affiliated Hospital of Anhui Medical University. The investigator was not involved in the voting of the ethics committee. The sponsor obtained written approval from the Independent Ethics Committee before the commencement of the study (review ID: YW2022-073; approval date: 20 May 2022). The study was conducted in accordance with the Declaration of Helsinki and the Chinese Good Clinical Practice Guidelines. Written informed consent was obtained from all patients before any study-related procedure was performed.

: Not applicable.

: All data generated or analyzed during this study are included in this published article.

: Wei Hu was the coordinating principal investigator of the study and involved in the development of the study protocol, study execution, and evaluation of the study results. Zhihai Cao and Yao Li were involved in drafting the manuscript and diagrams. Denny Hou, Shufang Wang and Wei Yao were involved in drafting the manuscript. Gaochong Zhang, Xiaoxiang Chu, and Xiaoyan Wang were involved in the study preparation, coordination, and evaluation of the trial. All the authors were involved in the review and approval of the manuscript and contributed to this work.