Interim analysis
In case of a rejection of the licensing process by the inspecting federal institute for drugs and medical devices, an interim analysis of the treatment effect of the APP condition on outcomes of the main study (LSAS, WHO-QOL-BREF, PDI) could turn out to be necessary. Such interim analysis will be blinded, that is, performed by different researchers than the respective research teams of the study and after reaching a sample size of 