- Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each Patient (or the subject's representative or relatives, depending on local regulations) according to Good Clinical Practice and regulatory and legal requirements of the participating country. Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtfully that they are wiling to participate voluntarily and must be able to understand an Explanation of the contents of the Information sheet