Table 2

Major protocol deviations and number of patients in the intention to treat (ITT) and per protocol (PP) analyses

*More than 25% of study medication was returned.
OM, omeprazole; OM+AMO, omeprazole plus amoxicillin.
There was no significant difference between the treatment groups.
Patients in ITT analysis9289181
Discontinuation due to adverse event123
Lost/refused to continue7714
    Study medication*022
    Use of prohibited medication549
    Day of visit235
Total patients with major protocol deviation181937
Patients in PP analysis7470144