Primary Efficacy Measure Sample Clauses

Primary Efficacy Measure. The primary efficacy measure will be all-cause mortality at 3 years following randomisation to study treatment. Subjects who prematurely discontinue study drug will then receive appropriate care and management from their physician. Such subjects will be followed at 12-weekly intervals to establish their mortality status at 156 weeks (3 years) post randomization. Analysis will be performed to compare treatment groups for survival based on a comparison of all subjects in the ITT population. The actual survival status of subjects who withdrew from the study before 156 weeks of treatment will be included in this analysis, rather than these subjects being censored at the point at which they withdrew. Subjects whose survival status is unknown at 156 weeks (i.e. 1092 days) will be censored at the timepoint at which they were last known to be alive.. The primary treatment comparison will be between the SERETIDE and placebo treatment groups within the ITT population, using the log-rank test, stratified by smoking status. Time to death will be calculated in days using the date of death. Adjusted