Table 3.
Test vs reference | Value, N | Adjusted least square means (SE) | Comparison of adjusted least square means (test vs reference) | ||||||
|
Day | Test | Reference | Test | Reference | Difference, test–reference (SE; 90% CI) | P value | ||
PEAR-004 (n=52) vs sham (n=54) | |||||||||
|
Analysis 1 | 29 | 52 | 54 | −1.6 (0.86) | −2.2 (0.84) | 0.61 (1.200; −1.4 to 2.6) | N/Ab | |
|
Analysis 2 | 57 | 49 | 47 | −2.5 (0.9) | −3.3 (0.9) | 0.80 (1.279; −1.3 to 2.9) | N/A | |
|
Analysis 3 | 85 | 48 | 49 | −2.6 (1.14) | −5.3 (1.13) | 2.73 (1.611; 0.1 to 5.4) | .09 |
aBaseline is the last measurement before treatment administration. Model: change from baseline of efficacy end point data was modeled using a mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment × visit, and baseline × visit interaction effects. The reported P value is 2-sided.
bN/A: not applicable.