Ethics approval and consent to participate
ADVERSE REACTIONS, RECRUITMENT
The protocol has been approved, and the informed consent has been reviewed by the Ethics Committee of the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine (approval number: IRB-AF/SG-18/01.0), with further monitoring routinely including the results. All participants will sign the informed consent (version date: 2021.11.19, version number: V1.1) for publication prior to enrollment, which will be kept by the designated investigator. The recruitment will start in the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, and the feedback and withdrawal rights of participants will be permanent during the trial. All the results (papers and reports) of this study will be published in peer-reviewed journals or conference collections. Any changes that affect the protocol implementation or are beneficial or harmful to patients, including sample size and intervention plan, should be carefully discussed and submitted to the ethics committee for review. In addition, due to the high safety of this trial, no adverse reactions have occurred since the clinical use of this instrument, so this study does not involve post-test care and compensation.