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Article History

Received: 2 May 2024

Accepted: 5 August 2024

First Online: 16 September 2024

Declarations

:

: The authors (Li-xin Guo, Lian-wei Wang, De-zeng Tian, Feng-mei Xu, Wei Huang, Xiao-hong Wu, Wei Zhu, Jun-Qiu Chen, Xin Zheng, Hai-Yan Zhou, Hong-Mei Li, Zhong-Chen He, Wen-Bo Wang, Li-Zhen Ma, Jun-Ting Duan) have no competing interests to declare.

: All patients signed the written informed consent. Participants were recruited from fifteen hospitals in China (Beijing Hospital; Yinchuan First People’s Hospital; Beijing Aerospace General Hospital; Peking University Shougang Hospital; Haidian Hospital of Beijing, Beijing Boai Hospital; Emergency General Hospital; Zhejiang Provincial People's Hospital; The First Affiliated Hospital of Zhejiang University School of Medicine, Beijing Hepingli Hospital, General Hospital of Civil Aviation, Anyang District Hospital of Puyang City, Zhumadian Central Hospital, Hebi Coal General Hospital, and The First People's Hospital of Qujing City). The study protocol was reviewed and approved by the local ethics committee. All procedures were following the Helsinki Declaration of 1964, as revised in 2013. Comprehensive information is provided to female participants of reproductive age during the screening phase. Participants who express reluctance to adhere to contraceptive requirements are excluded from the study. Throughout the follow-up period, clinical doctors advise female participants of reproductive age and assess their willingness to continue participating in the study. Informed, written consent was obtained from all participants in the study. This trial is registered with the Chinese Clinical Trial Registry (ChiCTR1900028606).