Ethics statement

The study was conducted in accordance with the Declaration of Helsinki, International Council for Harmonisation—Good Clinical Practice, including the archiving of essential documents guidelines and the applicable laws/regulations. All participants provided written informed consent. The protocol, amendments, and consent documentation were reviewed and approved by the institutional review board/independent ethics committees at each study center. There were four amendments to the original protocol (three non-substantial and one substantial), including an update to the planned study period, an increase in the number of planned study centers, and clarification of missing data processing related to the Coronavirus disease 2019 (COVID-19) outbreak (see Supplementary Methods).