 The statistics software packages SPSS 21 for Windows SPSS Inc., Chicago, USA and STATA 13.0 for Windows IBM were used in all statistical tests. Both per-protocol PP and intention-to-treat ITT analyses was employed for both primary and secondary outcomes. In bivariate analyses, within and between groups comparisons were made over the clinical trial period. When the outcome variables were continuous and followed a normal distribution, paired t test for related samples were performed to determine significant differences over time. Student t-test for independent samples was performed to compare the mean of the outcomes between intervention groups at baseline and follow-up review. When the outcome variables were continuous but did not follow a normal distribution as detected by normality test, Wilcoxon Signed Rank test a non-parametric equivalence of the paired t test for related samples was performed to determine significant differences over time. Mann Whitney U test a non-parametric equivalence of the t test for independent samples was employed to compare difference in the rank of outcomes between intervention groups at baseline and follow-up. When the outcome variables were categorical, McNemar test were performed to identify changes in prevalence over time and Chi-square test was employed to compare variations in prevalence between intervention groups at baseline and follow up. 