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Article History

Received: 23 July 2025

Accepted: 25 December 2025

First Online: 16 January 2026

Declarations

:

: The trial was approved by the Ethics Committee of the Beijing Children's Hospital of Capital Medical University (leading site), the Ethics Committee of the Affiliated Hospital of Guizhou Medical University, the Ethics Committee of the Third Xiangya Hospital of Central South University, the Ethics Committee of the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, the Ethics Committee of Sichuan University West China Second University Hospital, the Ethics Committee of Sichuan Provincial People's Hospital, the Ethics Committee of Tianjin Medical University General Hospital, and the Ethics Committee of Affiliated Hospital of Xuzhou Medical University, and adhered to the Declaration of Helsinki and Good Clinical Practice guidelines. The informed consent to participate was obtained from the parents or legal guardians of any participant under the age of 18. Meanwhile, patients aged ≥ 8 years also provided written informed consent. The study was registered at the ClinicalTrials.gov (NCT04867343) on April 30, 2021.

: Not applicable.

: Lei Tang and Yan Ding reported being employed by Jiangsu Hengrui Pharmaceuticals Co., Ltd. No other disclosures were reported.