Provisions for post-trial care {30}
SE, injuries
Once the patient finalizes the follow-up in the study, he/she will return to routine clinical follow-up in the outpatient clinic every 3–6 months depending on the clinical condition including screening ultrasound every 6 months when indicated.All patients participating in the trial will have insurance coverage by the sponsor which is in line with the applicable law and regulations, covering in its terms and provisions, its legal liability for injuries caused to participating persons arising out of this research performed strictly in accordance with scientific protocol as well as applicable law and professional standards. Insurance includes accidents on the way from the patient’s home to the study site and back; Insurance: HDI Global SE, insurance number: NEV050158A.