The primary analysis of efficacy wasperformed on the ITT population, whichincluded all patients who had both baseline and postrandomization efficacy values. For end-of-treatment analysis, thelast-observation-carried-forward methodwas used. All patients who received atleast one dose of trial medication were included in the safety analysis. Adverseevents and other safety parameters wereanalyzed in terms of the percentage of patients in whom they occurred.