Participant assessment and criteria
For efficacy assessment, both the full-analysis and the per-protocol analysis were performed. The full-analysis set (FAS) comprised participants with available efficacy outcome data who received study treatments at least once after randomization. The per-protocol set (PPS) comprised participants of the FAS who had completed the current study without serious violation of the study protocol.Safety analysis was performed for safety assessment, from the safety set which comprised participants who received study treatments at least once after randomization.