Fig. (1) Study design. The study consists of nine clinic visits (V1-V9) over 28 weeks. There is a 4-week screening period that includes Visit 1/Week –4 with single-blind placebo run-in at Visit 2/Week –3; and a 24-week double-blind phase that includes Visit 3/Week 0 (baseline), Visit 4/Week 4, Visit 5/Week 8, Visit 6/Week 12, Visit 7/Week 16, Visit 8/Week 20 and Visit 9/Week 24 (end of the study).