Table 1.
Study Timeline
| Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 | Visit 8 | Visit 9 | Visit 10 | Visit 11 | Visit 12 | Visit 13 | Visit 14 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Informed consent | X | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Physical exam | X | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Medical/migraine/medication history | X | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Vital signs | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Randomization | — | X | — | — | — | — | — | — | — | — | — | — | — | — |
| Administer treatment | — | X | X | X | X | X | X | X | X | X | X | X | X | — |
| Update medications | — | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Dispense headache diary | X | X | — | — | — | — | — | — | — | — | — | — | X | — |
| Review headache diary | — | X | — | — | X | — | — | X | — | — | X | — | — | X |
| Administer HIT-6 | — | X | — | — | — | — | — | — | — | — | — | — | — | X |
| Administer before procedure, 15 minutes postquestionnaire, and 30 minutes postquestionnaire | — | X | X | X | X | X | X | X | X | X | X | X | X | — |
| Dispense 24-hour questionnaire | — | X | X | X | X | X | X | X | X | X | X | X | X | — |
| Collect adverse events | — | — | X | X | X | X | X | X | X | X | X | X | X | X |
| Complete source doc/CRF | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
—, not completed; X, completed; CRF, case report form; HIT-6, Headache Impact Test.