Ethics approval and consent to participate
This multi-center, placebo-controlled, randomized, double-blinded, phase III clinical trial was conducted in 39 research centers in China. The research protocol adhered to the International Conference on Harmonization Guidelines for Good Clinical Practice, and regulations and directives set forth by autonomous local and/or national ethics committees. The Helsinki Declaration was followed in conducting all procedures. Institutional review boards granted approval of the protocol, consent forms, and additional pertinent documentation. Prior to the commencement of the study, signed informed consent were provided by all patients. The registration number was CTR20170362 (available at: 