Study design
This was a randomized, double-blind, placebo-controlled phase 3 study conducted from December 2019 to June 2021 across 22 study centers in China. The study protocol was approved by each center’s institutional review board or independent ethics committee. This study was conducted in accordance with the principles of Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. All participants provided written informed consent prior to screening. The results of the study were reported in adherence to the CONSORT reporting guidelines.