Study 409 was a Phase 3b/4 open-lab

Study 409 was a Phase 3b/4 open-label, multicenter, prospective study with an 8-week single-arm, open-label Acute Phase with MMX 4.8g/day given once daily and a 12-month single-arm, open-label Maintenance Phase with MMX 2.4g/day given once daily. Subjects who were suspected to have an acute flare of mild to moderate UC, with a known diagnosis established by sigmoidoscopy or colonoscopy with compatible histology, were screened. Subjects with a suspected, but not confirmed diagnosis of mild to moderate UC, were also screened; however, the diagnosis of UC must have been confirmed by sigmoidoscopy or colonoscopy with compatible histology prior to the Baseline Visit.