All primary and secondary parameters will be collected at Visits 1, 2 and 3. Missing data values will be minimized by intensive training of the interviewers in techniques of clarifying answers and checking questionnaires while participants are on-site. When missing values are identified, several approaches such as rescheduled within 24 hours of completion of tests or interviews will be employed to acquire the necessary data. Missing data will be also examined to assess randomness. Descriptive statistics will be obtained for all variables, tests of normality of continuous measures will be made and data will be examined for homogeneity of variance. An appropriate statistical method will be employed to correct for any abnormalities. The comparability of the two treatment groups in baseline demographic and clinical features will be tested with analyses of variance (ANOVAs) for continuous variables and Chi-square analyses for dichotomous variables. Initially, groups will be compared across all three visits for overall interaction effect. For any outcome with significant two-way interaction, group differences from baseline Visit to other two visits will be tested using analyses of variance with repeated measurements. These analyses were performed using the SPSS version 19. All analyses were two-tailed, where applicable, with p-value of 0.05 or less is obtained but other p-values may be evaluated on a case-by-case basis