Difference in Endpoint PSG Measures of Sleep (4 weeks)

PSG Measure StatisticPlacebo (n=109)

Pregabalin (n=108)

WASO, mina

LS mean ± SE 72.5±3.4 53.2±3.4

LS mean difference (95% CI) from placebo

-19.3 (-26 to -12.7)***

TST, minb

LS mean ± SE 370.6±4.7 396.2±4.7

LS mean difference (95% CI) from placebo

25.5 (17.5) to -33.6)***

LPS, minc

LS mean ± SE 41.6±3.7 34.5±3.7

LS mean difference (95% CI) from placebo

-7.2 (-14.2 to -0.17)**

Notes

*** P<0.0001; ** P=0.0447LS, least squares; SE, standard error; CI, confidence intervala Decrease in WASO was similar (-19.2 [-26.7 to -11.6]; P<0.0001) for primary endpoint WASO analyses performed on the per-protocol population.b Higher LS mean values (positive mean difference) indicate improved sleepc Higher LS mean values (negative mean difference) indicate improved sleep

Difference in Endpoint PSG Measures of Sleep for Patients Treated with Pregabalin & Placebo