Informed consent form for trial subjects Prior to any trial related activity, the investigator will give oral and written information about the trial in a form that the subject can read and understand. It is the investigators responsibility to ensure the trial subject is fully informed about the aims of the trial, procedures, potential risks, any discomforts and expected benefits. The investigator must ensure the subject is informed and agrees that VUMC personnel, their representatives and possibly health authority (national or other) personnel can require access to the subject's data. It must be emphasized that participation is voluntary and that the subject has the right to withdraw from the trial at any time without prejudice.