Safety of a long-term intervention with oleanolic acid in type 2 diabetes patients

[Methods for processing the data] All analyses were conducted on an intention-to-treat basis. The Kolmogorov–Smirnov test was performed to assess the distribution of quantitative variables. Continuous variables that significantly deviated from the assumption of normality were transformed accordingly. Continuous variables are presented as mean ± standard deviation, while categorical variables are presented as proportions. ?changes were calculated as changes produced between post- and pre-intervention (the value after 12-months of intervention minus value at baseline). Categorical variables were compared using Chi-square tests. Within-group and between-group changes were assessed using paired and unpaired t tests, respectively. To evaluate data variation according to intervention group and time (baseline to 12 months), repeated-measures ANOVA was conducted, followed by post-hoc multiple comparisons analysis using the Bonferroni correction. Analyses were adjusted for potential confounders or effect modifiers (age, sex, and BMI), except when the variable of interest already incorporated one or more of these covariates in its definition, in which case adjustments were not applied to avoid redundancy.