Yan, Qingran
Du, Fang
Kang, Yuening
Ye, Ping
Wang, Xiaodong
Xu, Jianhua
Tang, Jianping
Wang, Niansong
Jiang, Gengru
Li, Zhijun
Wang, Xuan
Xue, Qin
Huang, Xinfang
Zhang, Xiaoyan
Zhou, Ying
Dai, Min
Bao, Chunde
Funding for this research was provided by:
Shanghai Shenkang Promoting Project (16CR1027B)
Shanghai Municipal Population and Family Planning Commission (20204Y0088)
Article History
Received: 2 January 2021
Accepted: 21 July 2021
First Online: 11 August 2021
Declarations
:
: This study and all relevant data have been approved by the Medical Ethics Committee of Renji Hospital Shanghai Jiaotong University (number 2016[128 k]). The study progress is quickly reviewed by the committee yearly. The investigators will inform the ethics committee of any major changes to the protocol or consent materials. Any amendments would be approved by the committee. By far, there are no major changes to the protocol. We ensure that this study is conducted in accordance with the principles of the Declaration of Helsinki and the principles of Good Clinical Practice. Central ethics approval has been confirmed from the Medical Ethics Committee of Renji Hospital and we will not begin recruiting at other centers in the trial until local ethics approval has been obtained. This trial was registered at the China Clinical Trial Registry website under the identification numberExternalRef removed, NCT 02936375 on October 26, 2016. Signed informed consent forms will be obtained from all qualified participants before enrollment.
: Not applicable.
: The authors declare that they have no competing interests.