Zhao, Xinju
Wang, Pei
Wang, Lining
Chen, Xiaonong
Huang, Wen
Mao, Yonghui
Hu, Rihong
Cheng, Xiaohong
Wang, Caili
Wang, Li
Zhang, Ping
Li, Detian
Wang, Yuzhu
Ye, Wenling
Chen, Yuqing
Jia, Qiang
Yan, Xiaoyan
Zuo, Li
Funding for this research was provided by:
Special Fund for Public Health Research Benefit in the Public Interest from National Health and Family Planning Commission (201502010)
Article History
Received: 30 October 2018
Accepted: 15 November 2019
First Online: 9 December 2019
Ethics approval and consent to participate
: The study protocol was granted by the central ethical approval from Medicine Ethics Committee of the Peking University People’s Hospital (reference number 2014PHB018–01/2014PHB018–02/2014PHB018–03) and other institutional review boards (IRB) for every center. The other institutional review boards are Ethics Committee of Research/Pharmaceutical Clinical Trials of the First Affiliated Hospital of Zhengzhou University (reference number 2015–18), Medical Scientific Research Ethics Committee of the First Affiliated Hospital of China Medical University (reference number BA201402), Ethics Committee for Human Research Projects of Ruijin Hospital Affiliated to Shanghai Jiao Tong University (reference number 2014–54), Ethics Committee of Beijing Tongren Hospital Capital Medical University, Ethics Committee of Beijing Hospital (reference number 2014-BJYYEC-058-02), Medicine Ethics Committee of Hangzhou Hospital of Traditional Chinese Medicine (reference number 2014LL039), Ethics Committee of Shaanxi Hospital of Traditional Chinese Medicine (reference number 2014–08), Medicine Ethics Committee of the First Affiliated Hospital of BaoTou Medical College, Ethics Committee of Research/Pharmaceutical Clinical Trials Sichuan Academy of Medical Sciences (reference number 2014–8), Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University (reference number 2014–299), Ethics Committee of Shengjing Hospital of China Medical University (reference number 2014PS159K), Ethics Committee of Beijing Haidian Hospital (Beijing Haidian Section of Peking University Third Hospital, reference number 2014016), Ethics Committee of Peking Union Medical College Hospital (reference number B121), Ethics Committee of Peking University First Hospital (reference number 2014–793), Ethics Committee of Xuanwu Hospital Capital Medical University. Each important protocol modification will be communicated to the IRB, to ExternalRef removed and to each study center. Formal written consent was obtained for every participants.In order to maximize the collection of valuable data while minimizing patient burden, only necessary laboratory test and outcome measures will be collected. Invasive measures have been minimized to cause the least possible physical injury and physical stress. Ongoing training was provided to the research teams in conjunction with GCP.
: Not Applicable.
: The authors declare that they have no competing interests.