Document is current

Article History

Accepted: 3 December 2023

First Online: 6 January 2024

Declarations

:

: This work was sponsored by Haisco Pharmaceutical Group Co., Ltd.

: Nan Wu and Fengyi Zhang are employed by Haisco Pharmaceutical Group Co., Ltd. Other authors all declare no conflicts of interest.

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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

: Dan Shi and Gexuan Li organized the Administrative Bureau to steer the study progress. Lin Chen organized the study progresss in the Drug Clinical Trial Institution, the First Affiliated Hospital of Jinan University. Nan Wu and Fengyi Zhang designed the study protocol. Xiaofei Wang and Gexuan Li enrolled patients and did case records in Beijing Jishuitan Hospital, Capital Medical University. Nan Mu, Xi Chen, Xiangwei Yang, Jia Lu, and Yali Lu conducted the follow-up in the Phase I Research Center Ward. Nan Mu and Xi Chen were also responsible for data handling. Xiangwei Yang and Jia Lu were responsible for the judgment of data for publication. Yali Lu was responsible for statistical analysis. Meixia Wang and Dongliang Zhang were the guarantors of the entire works associated with the present study and take responsibility for the integrity of the data and the accuracy of data analysis. Dan Shi extensively contributed to the manuscript preparation. All authors reviewed and approved the manuscript before submission.