In the event that the subject is withdrawn from the study due to an AE, the AE will be recorded and reported, and the subject will be followed and treated until the abnormal parameter or symptom has resolved or stabilized. It is up to the clinician and the Data & Safety Monitoring Board to determine that the AE is either resolved or that it has reached a stable state, after which no further follow-up is necessary. Support for this determination will be documented. The reason for withdrawal from the study will be recorded on the appropriate case report form (CRF). If a subject is removed from the study, we will continue the scheduled follow-up with the subject's permission. There will be no changes to the follow-up schedule, except no study treatment/intervention will be administered. If at any point a subject no longer wishes to participate in follow-up, or after the three month follow-up telephone call, participation in the study will be complete. If new evidence emerges in the literature to indicate that our study dosage is unsafe, the study will be discontinued and all further qualifying patients will be offered the more effective/safer treatment.