The study drug, eMG; was eváluated

The study drug, eMG; was eváluated in 557 unique patients whose UC was in remission in controlled and open-label studies in the US and Russia. Overall, adverse events in the eMG clinical development program were similar to those attributable to other mesalamine ormulations. The majority of adverse events were related to the gastrointestinal system or were events common to the general population (i.e., headache, nasopharyngitis, and sinusitis).'wo populations were used for the safety analyses: the RCT population and the All eMG population. These populations were taken from the larger safety population which included all atients who received at least one dose of the study drug (eMG or placebo) and provided at least one post-baseline safety assessment. The RCT population included all safety patients in studies MPUC3003 and MPUC3004. The All eMG population included all patients in MPUC3003 and MPUC3004 who received eMG in addition to all patients from study MPUC3005, an open-label extension study.