Table 2.
PD simulation results
Typical PD trial estimand | Alternative treatment policy estimand | |||
PBO | Experimental | PBO | Experimental | |
Primary endpoint OFF-time (hours), n |
250 | 250 | 250 | 250 |
Mean (SE) | 5.28 (0.10) |
4.14 (0.10) |
4.90 (0.08) |
4.03 (0.08) |
Mean difference (SE) experimental vs PBO | −1.14 (0.14) |
−0.87 (0.12) |
||
95% CI | (−1.43 to –0.86) | (−1.11 to –0.64) | ||
P value | <0.001 | <0.001 |
CI, confidence interval; n, sample size; PBO, placebo; PD, Parkinson’s disease; SE, standard error.