Written informed consent will be obtained from each patient prior to enrollment into the trial. All potential patients will be properly informed as to the purposes of the trial and the potential risks/ benefits known, or that can be reasonably predicted or expected, by an Investigator trained in Good Clinical Practice. The investigator will retain the original copy of the Informed Consent Form signed by the patient, a duplicate will be given to the patient, and a third copy will be filed in the patient's hospital notes. Only the consent form approved by the relevant trial ethics committee will be used.