Value | Meaning |
---|---|
0.0 | Running Log |
1.0 | Visit 1 Screening (start 4-wk pbo run-in) |
1.1 | Unscheduled Visit Dated between Visits 1 and 2 |
1.2 | Unscheduled Visit Dated between Visits 1 and 2 |
2.0 | Visit 2 Randomization (4wks post Visit 1) |
2.1 | Unscheduled Visit Dated between Visits 2 and 3 |
2.2 | Unscheduled Visit Dated between Visits 2 and 3 |
2.3 | Unscheduled Visit Dated between Visits 2 and 3 |
3.0 | Visit 3 (Month 6) |
3.1 | Unscheduled Visit Dated between Visits 3 and 4 |
3.2 | Unscheduled Visit Dated between Visits 3 and 4 |
4.0 | Visit 4 (Month 12) |
4.1 | Unscheduled Visit Dated between Visits 4 and 5 |
5.0 | Visit 5 (Month 18) |
6.0 | Visit 6 (Month 24) |
7.0 | Visit 7 (Month 30) |
8.0 | Visit 8 (Month 36) |
9.0 | Visit 9 (Month 42) |
10.0 | Visit 10 (Month 48) |
51.0 | 1 Month Post-Randomization (for Japanese sites only - see protocol sec. 14.6, app. 6, Addition of Clinic Visits...) |
52.0 | 3 Months Post-Randomization (for Japanese sites only - see protocol sec. 14.6, app. 6, Addition of Clinic Visits...) |
80.0 | End of Study |
99.0 | Premature Withdrawal |