| Control Group | Treatment Group | Total | |
|---|---|---|---|
| Random Assignment | 35 | 35 | 70 |
| ITT population | |||
| inclusion | 35 | 35 | 70 |
| exclusion | 0 | 0 | 0 |
| PP population | |||
| inclusion | 29 | 33 | 62 |
| exclusion | 6 | 2 | 8 |
| Inclusion/Exclusion Criteria Violation | 5 | 1 | 6 |
| Withdrawal of Consent | 0 | 0 | 0 |
| Adverse Events | 0 | 0 | 0 |
| Follow-up Failure | 1 | 0 | 1 |
| Protocol Violation | 0 | 0 | 0 |
| Two consecutive instances of compliance below 80% | 0 | 1 | 1 |
| Etc. | 0 | 0 | 0 |