Li, Yuchuan
Guo, Peng
Jia, Chenguang
Yin, Ju
Yu, Yuncui
Qin, Qiang
Zhang, Xiaoyan
Zhao, Shunying
Yang, Haiming
Zhang, Weihua
Liang, Yuguang
Ding, Qian
Tian, Man
Chen, Yiping
Zhu, Chunmei
Wang, Fang
Ma, Jing
Huang, Lisu
Xie, Yongping
Bi, Jing
Shu, Sainan
Zhao, Chengsong https://orcid.org/0009-0008-5834-3643
Funding for this research was provided by:
Roche
Article History
Received: 27 August 2025
Accepted: 13 October 2025
First Online: 23 October 2025
Declarations
:
: All authors declare that they have no conflicts of interest. Chengsong Zhao, Yuchuan Li, Peng Guo, Chenguang Jia, Ju Yin, Yuncui Yu, Qiang Qin, Xiaoyan Zhang, Shunying Zhao, Haiming Yang, Weihua Zhang, Yuguang Liang, Qian Ding, Man Tian, Yiping Chen, Chunmei Zhu, Fang Wang, Jing Ma, Lisu Huang, Yongping Xie, Jing Bi and Sainan Shu have nothing to disclose.
: The clinical trial protocol and its amendments were reviewed and approved by the Independent Ethics Committee (IEC) of Beijing Children’s Hospital, Capital Medical University (Approval No. [2024]-Y-204-D and [2024]-Y-204-D-01). The study was conducted in accordance with the principles of the Declaration of Helsinki and was approved by the institutional review board or ethics committee at each center (Table in the supplementary material). The study was registered at the Chinese Clinical Trial Registry (ChiCTR2500098911), and was assigned a status of 'Retrospective Registration' because the first patient was enrolled while the initial registration application was under revision for formatting details, as per ChiCTR guidelines. The study protocol was finalized, and registration was initiated before the completion of patient enrollment and any data analysis. All parents/legal guardians of participating patients provided written informed consent. A patient and a parent/ legal guardian were free to withdraw participation from the trial at any time upon request.