4.4.2. Duration of the whole study Patients will be enrolled during a recruitment phase of approximately 2 years. Since minimum study duration for one patient is one year, the overall study duration is approximately 3 years. The Data Monitoring Committee may terminate the study earlier based on safety concerns at any time, or based on the interim efficacy analysis. Competent authorities/ethics committees retain the right for premature termination of the study according to applicable regulations. At an individual study centre, the study may be terminated early if the work performed is not compliant with Good Clinical Practice (GCP).