Statistical analysis
Sample size calculations were made a priori to ensure that the study would have enough power to detect statistical differences between groups and can be found as supplementary material for the present work. The power for these calculations was set in 80% and significance in 5%. Demographic and clinical characteristics were presented in tabular form using descriptive statistics (frequency, mean and standard deviation). To analyse data recollected from objective (MHD and AMSMD) and subjective tools (HIT-6, MIDAS and VAS) a descriptive test of the means was conducted. Accordingly, repeated measures One-Way ANOVA test (RM One-Way ANOVA) was used for parametric data and the repeated measures ANOVA on the ranks test (RM ANOVA Ranks) for non-parametric data. Post-hoc analysis was performed by using the Holm-Sidak test and only when ANOVA indicated significance. Mean, standard deviation (SD) and 95% confidence interval (95% CI) were used to express these data and the results represented in graphs were expressed as mean ± SD to be comparable to CTs. Statistical analyses were performed with SigmaPlot v11.0 (Systat Software Inc., Chicago, IL, USA) software.