The number (=n) of patients needed to detect a minimum mean difference of 50% between the baseline and the learning phase is 219 (a 0.05, power 80% two sided), and 219 in the three randomization groups. 80 patients per month present the inclusion criteria for the study. Thus, we need 2.7 months in the Baseline, a minimum of 2.7 months in the Learning and 8.1 months for the Randomization Intervention periods.