 3. The investigator will notify the accredited METC of the end of the study within a period of 8 weeks. The end of the study is defined as the last patients last visit. In case the study is ended prematurely, the investigator will notify the accredited METC, including the reasons for the premature termination. Within one year after the end of the study, the investigator will submit a final study report with the results of the study, including any publicationsabstracts of the study, to the accredited METC. 