Population to be analysed
Efficacy will be analysed based on the intention‐to‐treat (ITT) population and per‐protocol set (PPS). Safety will be analysed based on safety analysis set (SAS).
ITT: all randomly assigned patients.PPS: all the participants in the ITT except patients with violation of inclusion/exclusion criteria or violation for prohibited concomitant drugs/therapies.SAS: patients who received at least one dose of study drugs.