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Article History

Accepted: 14 August 2024

First Online: 4 September 2024

Declarations

:

: This study was funded by CStone Pharmaceuticals (Suzhou) Co., Ltd., Suzhou, China. The study sponsors collected, analyzed, and interpreted the data in conjunction with the authors, who had access to all the data.

: Lin Shen reports study funding from Astellas; grants or contracts from Beijing Xiantong Biomedical Technology, Qilu Pharmaceutical, ZaiLab Pharmaceutical (Shanghai), Beihai Kangcheng (Beijing) Medical Technology, Yaojie Ankang (Nanjing) Technology Co., Ltd., Baiji Shenzhou (Beijing) Biotechnology Co., Ltd., and Jacobio Pharmaceuticals; consulting fees from Mingji Biopharmaceuticals, Haichuang Pharmaceuticals, and Herbour BioMed; payment or honoraria for speakers bureaus from Hutchison Whampoa, Jiangsu Hengrui, ZaiLab, and CStone Pharmaceuticals; and data safety monitoring board or advisory board participation for MSD, Merck, Bristol-Meyers Squibb, Boehringer Ingelheim, Sanofi, Roche, Servier, and AstraZeneca. Rila Su, Zhongheng Cai, Zenglian Yue, Jinzhou Dou, Peiqi Li, Rachel Wu, and Archie N. Tse are employees of CStone Pharmaceuticals. Archie N. Tse and Rila Su own stock in CStone Pharmaceuticals. Jifang Gong, Ye Guo, Yanqiao Zhang, Yi Ba, Tong Chen, Wei Li, Caicun Zhou, Mengzhao Wang, Haiyan Yang, Yuhong Zhou, Qiqing Cai, Ziping Wang, Gang Huang, and Wei Zhang declare that they have no conflicts of interest that might be relevant to the contents of this manuscript.

: The trial protocol was approved by an independent Ethics Committee at each study center. The trial was conducted in compliance with applicable laws in China, and in accordance with the Chinese Guidelines for Good Clinical Practice and the principles outlined in the Declaration of Helsinki.

: All participants provided written, informed consent prior to participation.

: Not applicable.

: The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

: Not applicable.

: Jifang Gong: conceptualization, data curation, formal analysis, and writing—review and editing. Ye Guo: conceptualization, data curation, formal analysis, and writing—review and editing. Yanqiao Zhang: conceptualization, data curation, formal analysis, and writing—review and editing. Yi Ba: study design, conceptualization, data curation, formal analysis, and writing—review and editing. Tong Chen: conceptualization, data curation, formal analysis, and writing—review and editing. Wei Li: conceptualization, data curation, formal analysis, and writing—review and editing. Caicun Zhou: conceptualization, data curation, formal analysis, and writing—review and editing. Mengzhao Wang: conceptualization, data curation, formal analysis, and writing—review and editing. Haiyan Yang: conceptualization, data curation, formal analysis, and writing—review and editing. Yuhong Zhou: conceptualization, data curation, formal analysis, and writing—review and editing. Qiqing Cai: conceptualization, data curation, formal analysis, and writing—review and editing. Ziping Wang: conceptualization, data curation, formal analysis, and writing—review and editing. Gang Huang: conceptualization, data curation, formal analysis, and writing—review and editing. Wei Zhang: conceptualization, data curation, formal analysis, and writing—review and editing. Rila Su: conceptualization, data curation, formal analysis, and writing—review and editing. Zhongheng Cai: conceptualization, data curation, formal analysis, and writing—review and editing. Zenglian Yue: conceptualization, data curation, formal analysis, and writing—review and editing. Jinzhou Dou: conceptualization, data curation, formal analysis, and writing—review and editing. Peiqi Li: conceptualization, data curation, formal analysis, and writing—review and editing. Rachel Wu: conceptualization, data curation, formal analysis, and writing—review and editing. Archie N. Tse: conceptualization, data curation, formal analysis, and writing—review and editing. Lin Shen: conceptualization, data curation, formal analysis, and writing—review and editing.