The amount of financial resources needed for conducting the trial. It should be large enough to cover the reimbursement of all study procedures and exams, cost of submission to Ethic Committee (EC), insurance, contract with a Contract Research Organization (CRO), shipment of Investigational Product (IP) and any additional diagnosis device or device needed for the trial, monitoring, archiving, and general management and upkeeping activities. The study budget is discussed internally by the financial and clinical department and greenlighted by the Sponsor.