Ethics approval and consent to participate
CRF
CRF
This study including the protocol, consent forms, CRF and all study-related procedures has been approved by the Ethics committee at the Medical university of Graz (approval number: EK 32–230 ex 19/20). The Austrian authority for the conduct and safety of clinical trials (Bundesamt für Sicherheit im Gesundheitswesen, BASG, Medizinmarktaufsicht) has also voiced no objections to trial commencement (BASG number 13380395, procedure number 13301406). The study and its methods adhere to the ethical standards of the Declaration of Helsinki. Potential participants give their written informed consent prior to their screening visit.