As this is an observational study, there are no mandatory visits. While the timing of actual patient visits will occur at the discretion of the treating provider, it will be requested that data be entered at baseline and again 120 days after enrollment regardless of the number of times that a patient had been seen during that interval. All data will be collected and entered by the sites directly into a web-based electronic data capture (EDC) system via electronic case report forms (eCRFs).