2.3 Safety assessment
The following clinical safety assessments were included in the study: a physical examination, the vital signs (height, weight, blood pressure, heart rate, axillary temperature and respiratory rate), clinical laboratory tests (full blood count, urine routine, blood chemistry, coagulation function, stool routine & occult blood, 12-lead ECG cardiac monitoring, chest X-ray examination) and recording of the adverse events. Adverse experiences were monitored throughout the study. The investigators evaluated all the clinical adverse events in terms of the intensity (mild, moderate or severe), duration, severity, outcome and relationship to the study drug.