Jiang, Wenhan
Ma, Zifeng
Zhang, Huiyong
Lynn, Henry S.
Xu, Beiqi
Zhang, Xiao
Bi, Rongrong
Fu, Jiyou
Chen, Yue
Xiao, Zhen
Zhang, Zhijie http://orcid.org/0000-0002-1276-787X
Lu, Zhenhui
Funding for this research was provided by:
Shanghai Hospital Development Center (SHDC12017118)
Shanghai Municipal Commission of Health and Family Planning (ZY3-CCCX-2-1002, 201640218)
Long Hua Hospital (LYTD-36)
Article History
Received: 15 December 2017
Accepted: 8 June 2018
First Online: 4 July 2018
Ethics approval and consent to participate
: Ethical approval has been obtained through the Shanghai University of TCM affiliated Longhua Hospital Ethics Committee (Numbers 2016LCSY098). All participants provide written informed consent (clinical data and bio-sample). The trial is conducted in accordance with national laws, Good Clinical Practice guidelines, and the Declaration of Helsinki 2002. Any modification to the protocol, which may have impacted the conduct of the study, potential benefit of the patient or may affect patient safety required a formal amendment to the protocol, which should be approved by the Ethics Committee prior to implementation. Protocol modifications are communicated to all centers involved by means of regular meetings or telephone conversations. All staff are notified, trained, and qualified prior to conducting the trial.All subject-related information including case reports, laboratory specimens, and evaluation forms will be kept strictly confidential. All records are kept in a secure, locked place and secured with password-protected access systems. To protect confidentiality, identification information will be deleted from all study documents.
: Not applicable
: The authors declare that they have no competing interests.
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