Common use of Safety Analysis Clause in Contracts

Safety Analysis. Data will be summarized and tabulated based on the enrolled population for this Extension Study. All subjects enrolled in the Extension Study will be included in the safety analysis that will be performed on the following parameters: · Incidence and severity of AEs. · Pathological changes in hematology, chemistry and urinalysis data based on normal ranges supplied by the clinical laboratory, if applicable. Safety assessments for changes in physical examination, ▇▇▇▇▇ ▇▇▇▇▇, ECG, and laboratory tests will be descriptively summarized by treatment and study periods. Concomitant medication classes will be categorized using World Health Organization (WHO) drug dictionary and summarized by number and percent of subjects using each class by treatment group. All treatment emergent adverse events (TEAEs) will be coded for system organ class (SOC) and preferred term (PT) using MedDRA and the number (%) of subjects experiencing each AE (SOC/PT) will be summarized by treatment, relationship to treatment, and severity. All serious adverse events (SAE) will be listed and the number (%) of subjects with an SAE presented by treatment group.