9.3.4 External monitoring of study Adherence to study protocol will be monitored by an external agency. 10 ETHICAL AND LEGAL ASPECTS 10.1 Ethical committees (EC) The study will we conducted in accordance with the Helsinki declaration. Documented approval from appropriate ethical committees (EC) (applications will be sent to National Bioethics Committee (NBC) ("Vísindasiðanefnd"), The Data Protection Authority ("Persónuvernd") and from the Landspitali Medical Director will be obtained prior to the start of the study, according to good clinical practice (GCP), local laws, regulations and organizations. Regulatory authority approvals/authorizations notifications will be in place and fully documented prior to study start.