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Article History

Received: 29 March 2024

Accepted: 26 November 2024

First Online: 27 March 2025

Declarations

:

: The study protocol was approved by all participating sites, and informed consent of all participants (or their legally authorized guardians) were obtained in accordance with local institutions’ regulations. The ethics committees of study sites contributing to this manuscript include: Medical Ethics Committee of Xiangya Hospital Central South University; Clinical Research and Experimental Animal Ethics Committee of The First Affiliated Hospital, Sun Yat-sen University; Clinical Trial Ethics Committee of West China Second University Hospital, Sichuan University; Clinical Trial Ethics Committee of The Second Hospital of Hebei Medical University; Medical Ethics Committee of Hunan Children’s Hospital; Drug and Device Clinical Trial Ethics Committee of Jiangxi Provincial Children’s Hospital; Clinical Trial Ethics Committee of Children’s Hospital Affiliated to Shandong University; Medical Ethics Committee of Shenzhen Children’s Hospital; Ethics Committee of The First Hospital of Jilin University; Ethics Committee of Children’s Hospital of Chongqing Medical University; Medical Ethics Committee of The Second Affiliated Hospital of Xi’an Jiaotong University; Drug Clinical Trial Ethics Committee of The Third Affiliated Hospital of Zhengzhou University; Medical Ethics Committee of Children’s Hospital of Zhejiang University School of Medicine; Drug Clinical Trial Ethics Review Committee of Dalian Women and Children’s Medical Group; Ethics Committee of Fujian Medical University Union Hospital; Ethics Committee of Wuhan Children’s Hospital, Tongji Medical College Huazhong University of Science & Technology; Medical Ethics Committee of Shengjing Hospital of China Medical University; Ethics Committee of Children’s Hospital of Fudan University. The registry was registered on clinicaltrials.gov (NCT05042921).

: Not applicable.

: L.Z. is an employee of and holder of stock/stock options in Biogen. Y.X. was previously an employee of Biogen when this manuscript was developed. K.C. is an employee of IQVIA. Other authors report no relevant disclosures.