Study Visits and Measurements. Main Outcome Assessment Visits: The main visits for assessment of study outcomes are conducted at baseline and at weeks 26, 52, and 78 of follow-up. These visits each include 2 first-morning Up/c, a full panel of serum and urine biochemistry measurements, complete blood count, a quality of life assessment (SF-36 in adults; PedsQL in children), a complete physical examination, recording of medications and side effects, plus additional urine, serum, plasma specimens for storage in a repository. Whole blood for DNA extraction will be collected at onset of therapy and placed in a repository for consenting patients.