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Article History

Received: 14 October 2025

Revised: 29 December 2025

Accepted: 12 January 2026

First Online: 27 February 2026

Competing interests

: L.J., L.G., J.T., R.D., Z.Z. and H.S. received research funding from Gan & Lee Pharmaceuticals during the study. W.C. is a shareholder of Gan & Lee Pharmaceuticals. J.Z., L.Z., A.H., T.X. and Y.L. are employees of Gan & Lee Pharmaceuticals.

: The trial was conducted in accordance with the principles of the Declaration of Helsinki, the International Conference for Harmonization Guidance for Good Clinical Practice, and all applicable local laws and requirements. The trial protocol and amendments were approved by the lead institution, Peking University People’s Hospital (2023PHC014-001), as well as the ethics committees of each participating site. The trial was registered on June 7, 2023, on Chinadrugtrials.org.cn (identifier CTR20231695) before the first participant was enrolled on June 12, 2023, which complied with the World Health Organization (WHO) and the International Committee of Medical Journal Editors (ICMJE) guidelines and was subsequently registered on February 5, 2024, on ClinicalTrials.gov (identifier NCT06256562) to enhance international visibility.