Funding for this research was provided by:
Beijing Medical and Health Foundation (YWJKJJHKYJJ-TM19001)
National Science and Technology Major Project of China during the 13th Five-year plan period (2018ZX10302104)
Received: 26 February 2020
Accepted: 24 May 2020
First Online: 22 June 2020
Ethics approval and consent to participate
: We submitted the ethical review materials for this study to the ethics committee for the first time on January 17, 2019. After submission of the “Review Application” for the revised document according to the review opinion, this study was approved by the ethics committee of the Chongqing Public Health Medical Center (2019–003-02-KY) on January 28, 2019, and this approval covered local approval within other research centres. Confirmation of capacity and capability was also carried out by each local centre. Ethics approval documents and subsequent updated versions were filed at the local ethics committee. Written informed consent will be obtained from each patient before randomisation. All subjects will be requested to sign an informed consent form before enrolment in the study. If there are any changes to the protocol, the sponsor and the funder will be informed initially and then the principal investigator will notify the centres and will save a copy of the revised protocol in the investigator site file. Any deviations from the protocol will be fully documented using a breach report form. The information in the clinical trial registry will be updated according to the revised protocol. On the consent form, participants will be asked whether they agree to the use of their data should they choose to withdraw from the trial. Participants will also be asked for permission for the research team to share relevant data with the universities taking part in the research or from regulatory authorities, where relevant. This trial collects biological specimens for storage. There is no anticipated harm and compensation for trial participation, and there will be no further provision for post-trial care. Consent forms are available from the corresponding author on request.
: Not applicable.
: The authors declare that they have no competing interests.