Statistical analysis
Data were expressed as mean ± standard deviation and as percentages for categorical variables (before and after). Differences between groups (Obex® and placebo) were analysed by Mann–Whitney nonparametric independent sample test.Wilcoxon signed-rank tests were used to compare changes between baseline and the end of treatment (6 months) and the Friedman test was used for several related samples. In addition, both Pearson's Chi-square test and Fisher's exact test were used for categorical variables.Mann–Whitney tests were also used to compare baseline values between ERs and ENRs within each treatment group (Obex® and placebo). Wilcoxon-rank sum tests were utilised to compare changes at baseline and after six months of treatment between ERs and ENRs within each group.All significance tests and resulting 