Document is current

Article History

Received: 22 November 2019

Accepted: 12 June 2020

First Online: 22 June 2020

Ethics approval and consent to participate

: The trial has been approved by the Medical Ethics Committee of Nanfang Hospital, Southern Medical University. This protocol has been reviewed and approved by the sponsor and the ethical committees. Subsequent to initial review and approval, the sponsor and the ethical committees will review the protocol at least annually. The investigator will make safety and progress reports to the ethical committees at least annually and within 3 months of study termination or completion at her site. Any amendments to the protocol will be reviewed and approved by the ethics committee and funding support departments.Trained researchers will introduce the trial to patients. Patients will also receive information sheets. Researchers will discuss the trial with patients. Researchers will obtain written consent from patients willing to participate in the trial. On the consent form, participants will be asked if they agree to 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 people from the Universities taking part in the research or from regulatory authorities, where relevant. This trial does not involve collecting biological specimens for storage.

: This is available from the corresponding author on request.

: All academic conferences and research activities related to this study will be reimbursed. No other competing interests.