The primary analysis of efficacy was an intentionto-
treat (ITT) analysis of treatment success (heartburn
relief) at 4 weeks, using daily diary card responses, for
all randomized patients. Based on a priori hypotheses,
the proportions of patients with treatment success at
4 weeks were stratified by H. pylori status (positive or
negative) and age (less than or greater than or equal to
50 years of age) and results were compared between
treatment strategies using the Cochran–Mantel–Haenszel
test, controlling for geographical region. In addition,
a proportional hazards survival analysis was performed
to identify independent predictors of symptom relief in
the treatment phase and symptom relapse in the followup
phase