Statistical analysis of outcome measures, in dependence of scale level and distribution, according the post-hoc power-calculation will be performed. The statistical power of comparisons between cases and controls are evaluated. Difference in mean will be detected with level of significance 5%. In addition an alpha-adjustment for the entirety of all tests is planned. Also 95% confidence intervals will be calculated. Descriptives for all primary and secondary clinical, demographic and safety parameters will include absolute and relative frequencies for categorial variables and mean, standard deviation, median, and range for quantitative measurements, according the statistical analysis plan (SAP).