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Authors
Li, Xuening
Li, Hui
Xu, Hongrong
Yuan, Fei
Chen, Hanjing
Liu, Chao
Yang, Mengjie
Li, Jing
Sheng, Lei https://orcid.org/0000-0002-5784-076X
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Funding
Funding for this research was provided by:
National Major Scientific and Technological Special Project for “Significant New Drugs Development” (2018ZX09734-001)
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Article History
Received: 7 July 2025
Accepted: 13 November 2025
First Online: 8 December 2025
Declarations
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: Xuening Li, Hui Li, Hongrong Xu , Fei Yuan, Hanjing Chen, Chao Liu, Mengjie Yang, Jing Li, and Lei Sheng have no conflicts of interest that are directly relevant to the content of this article.
: This study was conducted in accordance with regulations and guidelines established by the International Council for Harmonisation Good Clinical Practice and the National Medical Products Administration. The study was registered at the Chinese Clinical Trial Registry (Registration no. CTR20170957; date of registration: 3 April, 2019). Prior to study initiation, the study protocol was approval by an Independent Ethics Committee at Zhongshan Hospital, Fudan University (approval number: 2019-019).
: All participants provided written informed consent before the study.
: Not applicable.
: All datasets generated in this study are available from the corresponding author upon reasonable request for research purposes.
: Not applicable.
: LS contributed to the analysis and interpretation of the data and writing of the initial draft of the paper. XL and HL were involved in the drafting process of the paper. HX, FY, HC, CL, MY, and JL performed the clinical trial. All authors have read and approved the final version.
