Table 2.
Major protocol deviations and number of patients in the intention to treat (ITT) and per protocol (PP) analyses
| OM | OM+AMO | Total | |
| Patients in ITT analysis | 92 | 89 | 181 |
| Discontinuation due to adverse event | 1 | 2 | 3 |
| Lost/refused to continue | 7 | 7 | 14 |
| Non-compliance | |||
| Study medication* | 0 | 2 | 2 |
| Use of prohibited medication | 5 | 4 | 9 |
| Day of visit | 2 | 3 | 5 |
| Other | 3 | 1 | 4 |
| Total patients with major protocol deviation | 18 | 19 | 37 |
| Patients in PP analysis | 74 | 70 | 144 |
*More than 25% of study medication was returned.
OM, omeprazole; OM+AMO, omeprazole plus amoxicillin.
There was no significant difference between the treatment groups.