Available in United States, Brazil
The study is comprised of a Baseline Visit and 2 Follow-up Periods. For Follow-up Periods
1 and 2, which includes Baseline through Year 5 visits, assessments will be performed at
the Investigational site. For the first 2 years (Follow-up Period 1), visits will occur
every 6 months. For Years 3 to 5 (Follow-up Period 2) follow-up visits will be conducted
annually. All patients will enter the study at the baseline visit and continue for 5
years.
175Patients around the world