Table 2.
Differences between dose level and study steps for study drug escalation
| Steps | Rapid-wean intervention | Slow-wean intervention | ||
|---|---|---|---|---|
| Dose level | % of stabilization dose | Dose level | % of stabilization dose | |
| Step 0 | Stabilization | 100% | Stabilization | 100% |
| Step 1 | Dose level A | 85% | Dose level A | 90% |
| Step 2 | Dose level B | 70% | Dose level B | 80% |
| Step 3 | Dose level C | 55% | Dose level C | 70% |
| Step 4 | Dose level B | 70%* | Dose level B | 80%* |
| Step 5 | Dose level C | 55% | Dose level C | 70% |
| Step 6 | Dose level D | 40% | Dose level D | 60% |
| Step 7 | Dose level E | 25% | Dose level E | 50% |
| Step 8 | Placebo | Placebo | Dose level F | 40% |
| Step 9 | Placebo | Placebo* | Dose level G | 30%* |
| Step 10 | Dose level E | 25% | Dose level F | 40% |
| Step 11 | Placebo | Placebo | Dose level G | 30% |
| Step 12 | Placebo | Placebo | Dose level H | 20% |
*dose level at a given study step was not successfully completed and resulted in an escalation