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Article History

Received: 23 October 2024

Accepted: 17 September 2025

First Online: 29 October 2025

Declarations

:

: The study was carried out in compliance with the Declaration of Helsinki. This study was approved by the Clinical Trial Ethics Committee of Huazhong University of Science and Technology (2021 − 118), the Drug Clinical Trial Ethics Committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences (002603), the Biomedical Research Ethics Committee of Peking University First Hospital (2021-088), the Drug/Medical Device Clinical Trial Ethics Committee of Guangzhou Women and Children’s Medical Center (YW-202109) and the Medical Ethics Committee of Children’s Hospital of Zhejiang University School of Medicine. Written informed consent was obtained from all the participants for publication.

: The work described has not been submitted elsewhere for publication, in whole or in part, and all the authors listed have approved the manuscript for publication.

: YJ and XL are Sanofi employees, YW is Sanofi former employee and Hengrui Pharma current employee. YW and XL hold stocks of Sanofi (China) Investment Co., Ltd. There are no potential conflicts of interest to disclose from YL, YLY, CCZ, LL, and XPL.