This study will require approximately 3-4 years for completion. Enrollment will occur over a 6 month period. All participants will be followed for 24 months after enrollment. Thus, it will take approximately 2.5 years to enroll, randomize and complete follow up for all of the patients in the study. An additional 6 months of preparation time will be required to develop the database and prepare each site for study enrollment. Following completion of follow up, we anticipate an additional 6 months will be necessary to complete all laboratory investigations, data analysis, data cleaning and completion of a manuscript.