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Safety Evaluation

KH Kai Huang
LQ Linling Que
YD Ying Ding
NC Nannan Chu
ZQ Zhenzhong Qian
YS Yunfei Shi
WQ Wei Qin
ZL Zhenni Li
YC Yuanxin Chen
XG Xianghong Gu
JW Jiakun Wang
LZ Lin Zhang
JZ Jisheng Zhang
XZ Xiangyang Zhu
YY Yongmin Yang
YT Yuan Tang
QH Qing He
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Safety was assessed by clinical observation and spontaneous reporting of adverse events (AEs) during the study. Clinical laboratory tests (blood chemistry, hematology, coagulation and urinalysis), 12-lead ECG, physical examination and vital signs were also assessed at the end of the study. All AEs were coded according to the Medical Dictionary for Regulatory Activities (MedDRA®) (version 20.0), and the seriousness and severity of AEs were recorded in term of the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.03).

Copyright and License information:  ©2021 Huang, Que, Ding, Chu, Qian, Shi, Qin, Li, Chen, Gu, Wang, Zhang, Zhang, Zhu, Yang, Tang and He.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

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