Liang, Lijun
Wen, Yixuan
Hu, Rong
Wang, Lei
Xia, Youyou
Hu, Chenxi
Qiao, Yun
Geng, Xiaowei
Chen, Ting
Fei, Jiayan
Hui, Kaiyuan
Jiang, Xiaodong
Funding for this research was provided by:
Jiangsu Province Key Research and Development Plan (Social Development) Project (BE2017684)
Scientific Research Project of Jiangsu Health and Family Planning Commission (H2017039)
National Natural Science Foundation of China (81472792, 81702813)
Postgraduate Research & Practice Innovation Program of Jiangsu Province (SJCX18_0707, SJCX19_0766)
Technology Office Foundation of Lianyungang City (SH1613)
Article History
Received: 19 August 2018
Accepted: 6 August 2019
First Online: 27 August 2019
Compliance with ethical standards
:
: The authors declare that they have no conflict of interest.
: The two single-center, open-label, phase I/II studies were conducted using a protocol approved by the medical ethics committee of the Affiliated Lianyungang Hospital of Xuzhou Medical University (2016016 and 2016018). All methods and procedures associated with this study were conducted in accordance with the International Conference on Harmonization Good Clinical Practice guidelines, the Declaration of Helsinki, and the Chinese law. These trials were registered with the Clinical Trials Registry (NCT02844881, NCT02858232).
: Informed consent for protocol therapy, the analysis of blood samples for research purposes, and the use of generated data for publication was obtained from all patients enrolled in this study.