Table 2.

Summary of efficacy results: ITT population

Outcome measure	Screening/baseline (s.d.)		LS mean change from baseline (s.e.) [95% CI]		LS mean difference (s.e.) [95% CI]	p value
	Pregabalin (N = 274)	Placebo (N = 265)	Pregabalin	Placebo
Primary efficacy endpoint, week 15 mean pain	6.41 (1.29)	6.54 (1.31)	−  2.12 (0.15) [− 2.42, − 1.82]	− 1.90 (0.16) [– 2.21, − 1.60]	– 0.22 (0.16) [– 0.54, 0.10]	0.1823
Week 1–15 overall mean pain effecta	6.41 (1.29)	6.54 (1.31)	– 2.10 (0.10) [– 2.29, − 1.90]	− 1.79 (0.10) [–1.99, − 1.60]	− 0.31 (0.12) [– 0.55, − 0.07]	0.0117
Sleep interference, week 15	4.97 (2.30)	4.99 (2.27)	− 2.29 (0.11) [− 2.51, − 2.07]	− 1.86 (0.11) [− 2.08, − 1.63]	− 0.43 (0.15) [− 0.71, − 0.14]	0.0031
Endpoint BPI pain severity	5.95 (1.50)	5.90 (1.50)	− 2.40 (0.13) [− 2.66, − 2.15]	− 1.95 (0.13) [− 2.21, − 1.69]	− 0.46 (0.16) [− 0.77, − 0.14]	0.0050
Endpoint BPI pain interference	4.07 (2.16)	4.06 (2.11)	− 1.72 (0.13) − 1.97, − 1.46]	− 1.33 (0.13) [− 1.59, − 1.07]	− 0.38 (0.16) [− 0.70, − 0.07]	0.0168

BPI brief pain inventory, CI confidence interval, ITT intention to treat, LS least squares, SD standard deviation, SE standard error

Primary analyses and sleep: mixed-model repeated measures, intention-to-treat population; Brief Pain Inventory-Short Form analysis of covariance

^aOverall is for each subject to pool pain score for all post-baseline weeks