Table 1.
Visit | Activity | Intention to treat (n) | Day | Allowable per protocol window | Per protocol (n) |
---|---|---|---|---|---|
Standard Dosing Schedule | |||||
| |||||
1 | Blood draw, Dose 1 | 109 | 0 | - | 109 |
2 | Dose 2 | 108 | 60 days after Dose 1 | 51–70 days after Dose 1 | 103 |
3 | Dose 3 | 107 | 183 days after Dose 1 | 174–193 days after Dose 1 | 87 |
4 | Post Dose 3 blood draw | 107 | 30 days after Dose 3 | 14–49 days after Dose 3 | 87 |
| |||||
Alternate Dosing Schedule | |||||
| |||||
1 | Blood draw, Dose 1 | 111 | 0 | - | 111 |
2 | Dose 2 | 110 | 60 days after Dose 1 | 51–70 days after Dose 1 | 110 |
3 | Dose 3 | 101 | 365 days after Dose 1 | 356–375 days after Dose 1 | 94 |
4 | Post Dose 3 blood draw | 97 | 30 days after Dose 3 | 14–49 days after Dose 3 | 88 |