Deliverable D6.4 provides the first study subject approvals package of the Clinical Observation Study (COS; formerly clinical validation study – CVS). This includes the registration number of the COS, a short report on the ethical approval status at all sites, and the document of the ethics board of the Sponsor (ethical committee of the Medical Faculty, University Hospital Schleswig-Holstein, Kiel, Germany) that reports about approval of the COS for Kiel site.