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Article History

Accepted: 15 September 2024

First Online: 4 October 2024

Declarations

:

: This study was sponsored and funded by CGeneTech (Suzhou, China) Co., Ltd. The study is supported by National Major Scientific and Technological Special Project for “Significant New Drugs Development” (2018ZX09301007-001).

: Jinmiao Lu, Jiahong Zhao, Juping Ding, Qiang Yu, and Tong Wang are employees of CGeneTech (Suzhou, China) Co., Ltd. Medical support was provided by Daosheng Xie, of Beijing noahpharm Medical Technology Co., Ltd, with funding from CGeneTech (Suzhou, China) Co., Ltd. No conflict of interest was reported by the authors.

: Jinmiao Lu, Daosheng Xie, Juping Ding, Jiahong Zhao, Qiang Yu, and Tong Wang were responsible for the concept and design of this article. Jinmiao Lu, Daosheng Xie, and Jiahong Zhao oversaw the data collection and performed the statistical analysis. Jinmiao Lu was a major contributor in writing the manuscript. All authors read and approved the final manuscript.

: Data from our study are not publicly available due to the sponsor’s contractual obligations. The data that support the findings of this study are available from the corresponding author (Dr. Tong Wang, wangt@cgenetech.com.cn) upon reasonable request.

: All of the trials were performed in accordance with principles of good clinical practice and the Declaration of Helsinki. All of the study protocols and all amendments were reviewed and approved by the appropriate ethics committees and authorities of all participating centers. All of the trials were registered in (chinadrugtrials.org registry numbers: CTR20180167, CTR20181331, CTR20190836, CTR20190599, CTR20200172, and CTR20200157).

: Not applicable.

: Informed consent was obtained from all individual participants included in the study.

: Not applicable.