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Article History

Accepted: 6 July 2021

First Online: 9 August 2021

Declarations

:

: This study was funded by Reistone Biopharma Co., Ltd.

: Aik Han Goh, Rongjun Liu, and Zhiguo Zhang are employees of Reistone Biopharma Co., Ltd. Yan Zhao, Litao Zhang, Yangfeng Ding, Xiaohua Tao, Chao Ji, Xiuqin Dong, Jianyun Lu, Liming Wu, Rupeng Wang, Qianjin Lu, and Jianzhong Zhang declare they have no conflicts of interest.

: This study was designed, funded, and managed by Reistone Biopharma Co., Ltd and was conducted by investigators contracted by and under the direction of the sponsor. Data collection, management, and analysis were conducted by Reistone Biopharma Co., Ltd. Confidentiality agreements were established between the authors and the sponsor. All authors participated in the interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication with no participation by or financial compensation from the sponsor. Medical writing and editorial support were provided by Parexel and funded by Reistone.

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

: Jianzhong Zhang had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

: This research was approved by the Institutional Review Board and Independent Ethics Committee of the Peking University People's Hospital and the participating study centers. The study was conducted in compliance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines, as well as all local regulatory requirements.

: All patients provided written informed consent and could withdraw from the study at any time at their own request or at the investigator’s or study sponsor’s discretion.

: Not applicable.

: Not applicable.

: Drafting of the manuscript, and acquisition, analysis, or interpretation of data: YZ. Acquisition, analysis, or interpretation of data: LZ, YD, XT, CJ, XD, JL, LW, RW, and QL. Concept and design, and statistical analysis: AHG, RL, and ZZ. Acquisition, analysis, or interpretation of data; critical revision of the manuscript for important intellectual content; supervision: JZ.