Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

Measure	Time frame	Description
Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6	Baseline, Week 6	IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline.

Measure	Time frame	Description
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)	CGI-S Scale: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6	Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Latency subscale (time to fall asleep \[in minutes\]): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Lower score reflects greater ease (shorter time) in falling asleep. Change from baseline = score at observation minus score at baseline.
Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6	Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Hours of sleep subscale reflects change in hours of sleep from baseline. Numerical rating completed by the subject 30 minutes after waking; recall period is the night before.
Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6	Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Number of awakenings subscale: numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Fewer awakenings reflect better quality of sleep. Change from baseline = score at observation minus score at baseline.
Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6	Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Total wake time after sleep onset subscale (in minutes): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Reduction = improvement. Change from baseline = score at observation minus score at baseline.
Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6	Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Quality of sleep subscale: visual analog scale ranging from 1 (very poor) to 100 (excellent) completed by the subject 30 minutes after waking; recall period is the night before. Change from baseline = score at observation minus score at baseline.
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Baseline, Week 1, Week 2, Week 4, Week 6	MOS-SS: subject-rated instrument used to assess the key constructs of sleep quantity and quality over the past week; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Disturbance Subscale score (4 items): range 0-100; lower score indicates less disturbance. Change from baseline = score at observation minus score at baseline.
Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Baseline, Week 1, Week 2, Week 4, Week 6	MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality over the past week. Comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Snoring Subscale score (1 item): range 0-100, lower score indicates less snoring. Change from baseline = score at observation minus score at baseline.
Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Baseline, Week 1, Week 2, Week 4, Week 6	MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week ; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Awaken Short of Breath or with Headache subscale score range: 0-100; lower score indicates less difficulty. Change from baseline = score at observation minus score at baseline.
Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	Week 6	Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 6 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.
Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Baseline,, Week 1, Week 2, Week 4, Week 6	MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Somnolence Subscale score range: 0-100; higher score indicates less somnolence. Change from baseline = score at observation minus score at baseline.
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Baseline,, Week 1, Week 2, Week 4, Week 6	MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Quantity (1 item) subscale score range: 0-24 hours. Change from Baseline in number of hours slept. Change from baseline = score at observation minus score at baseline.
Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Baseline, Week 1, Week 2, Week 4, Week 6	MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Problems Index I (6 items): composite index score range 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.
Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Baseline, Week 1, Week 2, Week 4, Week 6	MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Composite index scores are sleep problems Index I (6 items) and sleep problems Index II (9 items). 9-Item Sleep Problems Index range: 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.
Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 1, Week 2, Week 4, Week 6	MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours of sleep per night.
Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6	Baseline, Week 6	RLS QoL: subject-rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period is the month prior to the assessment. Change from baseline = score at observation minus score at baseline.
Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Baseline, Week 6	Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Recall period: month prior to the assessment. Change from baseline = score at observation minus score at baseline.
Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline, Week 6	Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Self-evaluated change in health status: 5 Likert-type response categories ranging from much worse now to much better now. Recall period: month prior to the assessment.
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Baseline, Week 1, Week 2, Week 4, Week 6	MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Adequacy Subscale score range: 0-100; higher scores indicates greater sleep adequacy. Change from baseline = score at observation minus score at baseline.

Arm	Count
Placebo Single daily oral dose.	23
Pregabalin 50 mg Single daily 50 mg oral dose.	22
Pregabalin 100 mg Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.	23
Pregabalin 150 mg Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.	22
Pregabalin 300 mg Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).	24
Pregabalin 450 mg Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).	23
Total	137

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Overall Study	Adverse Event	1	2	0	5	1	2
Overall Study	Lost to Follow-up	0	0	0	0	0	1
Overall Study	Reason Unspecified	1	0	1	0	0	1
Overall Study	Withdrawal by Subject	0	0	0	0	0	1

Characteristic	Placebo	Pregabalin 50 mg	Pregabalin 100 mg	Pregabalin 150 mg	Pregabalin 300 mg	Pregabalin 450 mg	Total
Age, Customized 18 - 44 years	4 participants	5 participants	7 participants	2 participants	9 participants	3 participants	30 participants
Age, Customized 45 - 64 years	19 participants	15 participants	16 participants	20 participants	15 participants	19 participants	104 participants
Age, Customized >=65 years	0 participants	2 participants	0 participants	0 participants	0 participants	1 participants	3 participants
Sex: Female, Male Female	13 Participants	13 Participants	16 Participants	13 Participants	19 Participants	16 Participants	90 Participants
Sex: Female, Male Male	10 Participants	9 Participants	7 Participants	9 Participants	5 Participants	7 Participants	47 Participants

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	13 / 23	9 / 22	12 / 23	15 / 22	17 / 24	19 / 23
serious Total, serious adverse events	0 / 23	1 / 22	0 / 23	0 / 22	0 / 24	0 / 23

Primary

Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6

IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline, Week 6

Population: ITT. Baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit. Recall period = week prior to assessment.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6	-7.73 scores on scale	Standard Error 1.72
Pregabalin 50 mg	Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6	-11.83 scores on scale	Standard Error 1.771
Pregabalin 100 mg	Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6	-11.76 scores on scale	Standard Error 1.694
Pregabalin 150 mg	Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6	-16.02 scores on scale	Standard Error 1.865
Pregabalin 300 mg	Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6	-12.89 scores on scale	Standard Error 1.713
Pregabalin 450 mg	Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6	-16.26 scores on scale	Standard Error 1.771

Comparison: Dose response analysis ED 50: dose providing 50% of the maximal effect. Statistics were obtained from three parameter model Y = D + G\*exp(B\*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.95% CI: [0.1, 157.7]ED-50: Bootstrap Method

Comparison: Dose response analysis ED 90: dose providing 90% of the maximal effect. Statistics were obtained from three parameter model Y = D + G\*exp(B\*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.95% CI: [0.4, 523.9]ED 90: Bootstrap Method

Comparison: Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.098395% CI: [-8.97, 0.77]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.096695% CI: [-8.78, 0.73]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.001395% CI: [-13.31, -3.28]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.035395% CI: [-9.96, -0.36]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.000695% CI: [-13.4, -3.67]Mixed Models Analysis

Secondary

Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6

Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Recall period: month prior to the assessment. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline, Week 6

Population: ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, had baseline and post-baseline values.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Summary Emotional Score	3.7 scores on scale	Standard Error 3.33
Placebo	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Role-Emotional	-2.1 scores on scale	Standard Error 4.16
Placebo	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Summary Physical Score	4.5 scores on scale	Standard Error 2.83
Placebo	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Role-Physical	1.1 scores on scale	Standard Error 4.24
Placebo	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Bodily Pain	6.9 scores on scale	Standard Error 4.16
Placebo	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Physical Functioning	3.6 scores on scale	Standard Error 3.5
Placebo	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	General Health	6.5 scores on scale	Standard Error 2.81
Placebo	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Mental Health	2.9 scores on scale	Standard Error 3.49
Placebo	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Vitality	7.4 scores on scale	Standard Error 3.98
Placebo	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Social Functioning	7.8 scores on scale	Standard Error 3.98
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Social Functioning	8.3 scores on scale	Standard Error 4.2
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Physical Functioning	0.5 scores on scale	Standard Error 3.71
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	General Health	5.2 scores on scale	Standard Error 3.05
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Mental Health	1.0 scores on scale	Standard Error 3.68
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Role-Emotional	6.7 scores on scale	Standard Error 4.38
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Bodily Pain	15.8 scores on scale	Standard Error 4.41
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Summary Emotional Score	6.9 scores on scale	Standard Error 3.51
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Summary Physical Score	7.4 scores on scale	Standard Error 3.02
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Vitality	11.1 scores on scale	Standard Error 4.18
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Role-Physical	7.0 scores on scale	Standard Error 4.49
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Vitality	9.9 scores on scale	Standard Error 3.86
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Mental Health	3.6 scores on scale	Standard Error 3.43
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Physical Functioning	2.4 scores on scale	Standard Error 3.42
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Summary Physical Score	6.7 scores on scale	Standard Error 2.77
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Social Functioning	4.8 scores on scale	Standard Error 3.88
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	General Health	4.0 scores on scale	Standard Error 2.75
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Role-Physical	7.5 scores on scale	Standard Error 4.14
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Summary Emotional Score	6.7 scores on scale	Standard Error 3.24
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Bodily Pain	12.9 scores on scale	Standard Error 4.07
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Role-Emotional	7.8 scores on scale	Standard Error 4.05
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Role-Emotional	1.0 scores on scale	Standard Error 4.63
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Role-Physical	7.7 scores on scale	Standard Error 4.77
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Summary Emotional Score	8.2 scores on scale	Standard Error 3.72
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Bodily Pain	16.9 scores on scale	Standard Error 4.87
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Physical Functioning	-0.4 scores on scale	Standard Error 3.93
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	General Health	7.5 scores on scale	Standard Error 3.15
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Social Functioning	4.4 scores on scale	Standard Error 4.47
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Mental Health	7.6 scores on scale	Standard Error 3.9
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Vitality	18.5 scores on scale	Standard Error 4.46
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Summary Physical Score	8.2 scores on scale	Standard Error 3.29
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Mental Health	3.7 scores on scale	Standard Error 3.47
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Physical Functioning	2.9 scores on scale	Standard Error 3.52
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Role-Physical	0.9 scores on scale	Standard Error 4.24
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Bodily Pain	13.3 scores on scale	Standard Error 4.17
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	General Health	3.6 scores on scale	Standard Error 2.82
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Vitality	11.7 scores on scale	Standard Error 3.95
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Social Functioning	9.5 scores on scale	Standard Error 4
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Role-Emotional	8.1 scores on scale	Standard Error 4.13
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Summary Emotional Score	8.5 scores on scale	Standard Error 3.32
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Summary Physical Score	5.6 scores on scale	Standard Error 2.85
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Summary Emotional Score	13.5 scores on scale	Standard Error 3.43
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Role-Emotional	12.7 scores on scale	Standard Error 4.31
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Summary Physical Score	9.7 scores on scale	Standard Error 2.94
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Social Functioning	15.6 scores on scale	Standard Error 4.1
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Vitality	13.9 scores on scale	Standard Error 4.08
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	General Health	5.9 scores on scale	Standard Error 2.9
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Bodily Pain	18.1 scores on scale	Standard Error 4.31
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Role-Physical	9.6 scores on scale	Standard Error 4.4
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Physical Functioning	3.6 scores on scale	Standard Error 3.62
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	Mental Health	10.7 scores on scale	Standard Error 3.59

Comparison: Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.538495% CI: [-13.2, 7]ANCOVA

Comparison: Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.801595% CI: [-10.9, 8.5]ANCOVA

Comparison: Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.442995% CI: [-14.5, 6.4]ANCOVA

Comparison: Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.88695% CI: [-10.5, 9.1]ANCOVA

Comparison: Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.996395% CI: [-10, 9.9]ANCOVA

Comparison: Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.342195% CI: [-6.3, 18.1]ANCOVA

Comparison: Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.284995% CI: [-5.4, 18.1]ANCOVA

Comparison: Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.305895% CI: [-6.1, 19.2]ANCOVA

Comparison: Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.960495% CI: [-12.1, 11.5]ANCOVA

Comparison: Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.166195% CI: [-3.6, 20.6]ANCOVA

Comparison: Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.144195% CI: [-3.1, 20.9]ANCOVA

Comparison: Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.307695% CI: [-5.6, 17.5]ANCOVA

Comparison: Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.120995% CI: [-2.7, 22.7]ANCOVA

Comparison: Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.279195% CI: [-5.3, 18]ANCOVA

Comparison: Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.064495% CI: [-0.7, 23]ANCOVA

Comparison: General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.754495% CI: [-9.5, 6.9]ANCOVA

Comparison: General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.514295% CI: [-10.3, 5.2]ANCOVA

Comparison: General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.815895% CI: [-7.4, 9.4]ANCOVA

Comparison: General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.459995% CI: [-10.8, 4.9]ANCOVA

Comparison: General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.863695% CI: [-8.7, 7.3]ANCOVA

Comparison: Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.528195% CI: [-7.8, 15.1]ANCOVA

Comparison: Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.656695% CI: [-8.5, 13.5]ANCOVA

Comparison: Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.067795% CI: [-0.8, 23]ANCOVA

Comparison: Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.444395% CI: [-6.8, 15.4]ANCOVA

Comparison: Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.254395% CI: [-4.7, 17.7]ANCOVA

Comparison: Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.941695% CI: [-11, 11.9]ANCOVA

Comparison: Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.582495% CI: [-14.1, 7.9]ANCOVA

Comparison: Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.566895% CI: [-15.3, 8.4]ANCOVA

Comparison: Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.776995% CI: [-9.6, 12.8]ANCOVA

Comparison: Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.175395% CI: [-3.5, 19.1]ANCOVA

Comparison: Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.150895% CI: [-3.2, 20.7]ANCOVA

Comparison: Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.091695% CI: [-1.6, 21.4]ANCOVA

Comparison: Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.622295% CI: [-9.2, 15.4]ANCOVA

Comparison: Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.08595% CI: [-1.4, 21.8]ANCOVA

Comparison: Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.015495% CI: [2.9, 26.7]ANCOVA

Comparison: Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.720195% CI: [-11.9, 8.2]ANCOVA

Comparison: Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.887595% CI: [-9.1, 10.5]ANCOVA

Comparison: Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.373595% CI: [-5.7, 15.1]ANCOVA

Comparison: Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.862195% CI: [-8.9, 10.6]ANCOVA

Comparison: Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.120395% CI: [-2.1, 17.8]ANCOVA

Comparison: Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.496695% CI: [-5.4, 11]ANCOVA

Comparison: Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.577695% CI: [-5.6, 10.1]ANCOVA

Comparison: Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.395595% CI: [-4.9, 12.3]ANCOVA

Comparison: Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.799495% CI: [-6.9, 9]ANCOVA

Comparison: Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.207395% CI: [-2.9, 13.2]ANCOVA

Comparison: Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.514895% CI: [-6.4, 12.8]ANCOVA

Comparison: Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.525595% CI: [-6.3, 12.2]ANCOVA

Comparison: Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.379395% CI: [-5.5, 14.4]ANCOVA

Comparison: Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.31295% CI: [-4.5, 14.1]ANCOVA

Comparison: Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.044295% CI: [0.3, 19.2]ANCOVA

Secondary

Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores

Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Self-evaluated change in health status: 5 Likert-type response categories ranging from much worse now to much better now. Recall period: month prior to the assessment.

Time frame: Baseline, Week 6

Population: ITT; N = number of subjects in a treatment group.

Arm	Measure	Group	Value (NUMBER)
Placebo	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Somewhat Better than 1 Year Ago	2 participants
Placebo	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: About the Same as 1 Year Ago	15 participants
Placebo	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Much Better than 1 Year Ago	3 participants
Placebo	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Somewhat Better than 1 Year Ago	4 participants
Placebo	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: About the Same as 1 Year Ago	11 participants
Placebo	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Somewhat Worse than 1 Year Ago	2 participants
Placebo	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Somewhat Worse than 1 Year Ago	4 participants
Placebo	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Much Worse than 1 Year Ago	0 participants
Placebo	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Much Worse than 1 Year Ago	1 participants
Placebo	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Much Better than 1 Year Ago	1 participants
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Somewhat Worse than 1 Year Ago	6 participants
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Much Worse than 1 Year Ago	3 participants
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: About the Same as 1 Year Ago	9 participants
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Somewhat Better than 1 Year Ago	1 participants
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Much Better than 1 Year Ago	1 participants
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Much Worse than 1 Year Ago	0 participants
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Somewhat Worse than 1 Year Ago	3 participants
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: About the Same as 1 Year Ago	12 participants
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Somewhat Better than 1 Year Ago	2 participants
Pregabalin 50 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Much Better than 1 Year Ago	2 participants
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Somewhat Better than 1 Year Ago	3 participants
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: About the Same as 1 Year Ago	10 participants
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Much Worse than 1 Year Ago	1 participants
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Much Better than 1 Year Ago	1 participants
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: About the Same as 1 Year Ago	15 participants
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Somewhat Worse than 1 Year Ago	3 participants
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Much Worse than 1 Year Ago	0 participants
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Somewhat Better than 1 Year Ago	4 participants
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Much Better than 1 Year Ago	6 participants
Pregabalin 100 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Somewhat Worse than 1 Year Ago	2 participants
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Somewhat Worse than 1 Year Ago	4 participants
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: About the Same as 1 Year Ago	11 participants
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Somewhat Worse than 1 Year Ago	4 participants
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Much Better than 1 Year Ago	1 participants
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Somewhat Better than 1 Year Ago	1 participants
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Much Worse than 1 Year Ago	2 participants
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Much Worse than 1 Year Ago	0 participants
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Much Better than 1 Year Ago	0 participants
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Somewhat Better than 1 Year Ago	0 participants
Pregabalin 150 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: About the Same as 1 Year Ago	14 participants
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Somewhat Worse than 1 Year Ago	3 participants
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Somewhat Better than 1 Year Ago	5 participants
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Much Better than 1 Year Ago	1 participants
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Much Worse than 1 Year Ago	2 participants
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Much Worse than 1 Year Ago	3 participants
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: About the Same as 1 Year Ago	12 participants
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Much Better than 1 Year Ago	2 participants
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Somewhat Better than 1 Year Ago	4 participants
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: About the Same as 1 Year Ago	14 participants
Pregabalin 300 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Somewhat Worse than 1 Year Ago	1 participants
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Much Worse than 1 Year Ago	0 participants
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Much Better than 1 Year Ago	4 participants
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Somewhat Worse than 1 Year Ago	3 participants
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: About the Same as 1 Year Ago	12 participants
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Much Better than 1 Year Ago	2 participants
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Somewhat Worse than 1 Year Ago	1 participants
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Somewhat Better than 1 Year Ago	2 participants
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: About the Same as 1 Year Ago	10 participants
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Baseline: Much Worse than 1 Year Ago	2 participants
Pregabalin 450 mg	Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	Week 6: Somewhat Better than 1 Year Ago	5 participants

Comparison: CHM test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.4452Cochran-Mantel-Haenszel

Comparison: CHM test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.4342Cochran-Mantel-Haenszel

Comparison: CHM test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.0942Cochran-Mantel-Haenszel

Comparison: CHM test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.1873Cochran-Mantel-Haenszel

Comparison: CHM test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.4709Cochran-Mantel-Haenszel

Secondary

Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Problems Index I (6 items): composite index score range 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline, Week 1, Week 2, Week 4, Week 6

Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 2	-14.8 scores on scale	Standard Error 3.67
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 6	-15.5 scores on scale	Standard Error 3.76
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 4	-17.2 scores on scale	Standard Error 3.71
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 1	-9.2 scores on scale	Standard Error 3.67
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 6	-25.0 scores on scale	Standard Error 3.97
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 2	-22.0 scores on scale	Standard Error 3.97
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 1	-12.5 scores on scale	Standard Error 3.91
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 4	-17.9 scores on scale	Standard Error 3.92
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 6	-21.1 scores on scale	Standard Error 3.71
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 1	-10.4 scores on scale	Standard Error 3.75
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 4	-19.6 scores on scale	Standard Error 3.67
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 2	-15.7 scores on scale	Standard Error 3.71
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 1	-14.9 scores on scale	Standard Error 4.06
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 2	-20.3 scores on scale	Standard Error 4.09
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 4	-23.3 scores on scale	Standard Error 4.09
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 6	-26.1 scores on scale	Standard Error 4.15
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 6	-18.8 scores on scale	Standard Error 3.79
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 2	-20.1 scores on scale	Standard Error 3.79
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 1	-13.9 scores on scale	Standard Error 3.77
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 4	-24.4 scores on scale	Standard Error 3.79
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 1	-16.2 scores on scale	Standard Error 3.77
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 4	-28.9 scores on scale	Standard Error 3.88
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 2	-24.1 scores on scale	Standard Error 3.87
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	Week 6	-27.6 scores on scale	Standard Error 3.88

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.540995% CI: [-13.8, 7.3]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.82395% CI: [-11.5, 9.2]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.295895% CI: [-16.5, 5.1]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.370895% CI: [-15.1, 5.7]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.185395% CI: [-17.4, 3.4]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.183495% CI: [-17.9, 3.4]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.871195% CI: [-11.1, 9.4]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.325295% CI: [-16.3, 5.4]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.320595% CI: [-15.7, 5.1]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.083795% CI: [-19.8, 1.2]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.889595% CI: [-11.4, 9.9]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.646995% CI: [-12.7, 7.9]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.268795% CI: [-17, 4.8]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.175795% CI: [-17.7, 3.3]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.030695% CI: [-22.3, -1.1]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.085795% CI: [-20.2, 1.3]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.293295% CI: [-16, 4.8]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.061395% CI: [-21.6, 0.5]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.543195% CI: [-13.8, 7.3]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.026295% CI: [-22.7, -1.4]Mixed Models Analysis

Secondary

Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Composite index scores are sleep problems Index I (6 items) and sleep problems Index II (9 items). 9-Item Sleep Problems Index range: 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline, Week 1, Week 2, Week 4, Week 6

Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 1	-8.1 scores on scale	Standard Error 3.73
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 2	-15.5 scores on scale	Standard Error 3.73
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 4	-18.2 scores on scale	Standard Error 3.77
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 6	-16.8 scores on scale	Standard Error 3.81
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 1	-15.9 scores on scale	Standard Error 3.96
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 2	-23.5 scores on scale	Standard Error 4.03
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 6	-27.5 scores on scale	Standard Error 4.03
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 4	-19.3 scores on scale	Standard Error 3.98
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 6	-22.2 scores on scale	Standard Error 3.76
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 4	-22.0 scores on scale	Standard Error 3.73
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 2	-19.0 scores on scale	Standard Error 3.76
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 1	-14.2 scores on scale	Standard Error 3.81
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 4	-25.2 scores on scale	Standard Error 4.15
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 1	-17.8 scores on scale	Standard Error 4.12
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 2	-22.5 scores on scale	Standard Error 4.15
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 6	-28.3 scores on scale	Standard Error 4.21
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 2	-23.3 scores on scale	Standard Error 3.86
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 6	-22.3 scores on scale	Standard Error 3.86
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 1	-14.4 scores on scale	Standard Error 3.84
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 4	-27.0 scores on scale	Standard Error 3.86
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 2	-24.6 scores on scale	Standard Error 3.93
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 6	-29.4 scores on scale	Standard Error 3.93
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 1	-18.8 scores on scale	Standard Error 3.83
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	Week 4	-29.1 scores on scale	Standard Error 3.93

Comparison: Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.154795% CI: [-18.5, 3]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.253295% CI: [-16.6, 4.4]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.084895% CI: [-20.6, 1.3]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.242495% CI: [-16.8, 4.3]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.04795% CI: [-21.2, -0.1]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.149495% CI: [-18.8, 2.9]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.508195% CI: [-13.9, 6.9]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.214195% CI: [-17.9, 4]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.148495% CI: [-18.4, 2.8]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.096395% CI: [-19.7, 1.6]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.851995% CI: [-11.8, 9.8]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.47795% CI: [-14.2, 6.7]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.216695% CI: [-18, 4.1]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.106295% CI: [-19.4, 1.9]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.047595% CI: [-21.6, -0.1]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.053795% CI: [-21.7, 0.2]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.315395% CI: [-15.9, 5.2]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.042495% CI: [-22.8, -0.4]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.307795% CI: [-16.2, 5.1]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.022495% CI: [-23.4, -1.8]Mixed Models Analysis

Secondary

Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week ; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Awaken Short of Breath or with Headache subscale score range: 0-100; lower score indicates less difficulty. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline, Week 1, Week 2, Week 4, Week 6

Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 4	-9.9 scores on scale	Standard Error 3.56
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 1	-7.3 scores on scale	Standard Error 3.49
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 2	-9.1 scores on scale	Standard Error 3.49
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 6	-7.4 scores on scale	Standard Error 3.63
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 2	-4.3 scores on scale	Standard Error 3.81
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 6	-0.9 scores on scale	Standard Error 3.81
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 1	-1.7 scores on scale	Standard Error 3.72
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 4	-2.5 scores on scale	Standard Error 3.73
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 6	-4.9 scores on scale	Standard Error 3.54
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 2	-8.8 scores on scale	Standard Error 3.54
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 1	-5.3 scores on scale	Standard Error 3.62
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 4	-8.9 scores on scale	Standard Error 3.47
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 1	-9.2 scores on scale	Standard Error 3.92
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 4	-9.9 scores on scale	Standard Error 3.93
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 2	-12.1 scores on scale	Standard Error 3.93
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 6	-11.5 scores on scale	Standard Error 4.03
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 1	-8.6 scores on scale	Standard Error 3.51
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 2	-8.2 scores on scale	Standard Error 3.53
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 4	-9.1 scores on scale	Standard Error 3.53
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 6	-3.0 scores on scale	Standard Error 3.53
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 1	1.4 scores on scale	Standard Error 3.58
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 2	-1.1 scores on scale	Standard Error 3.72
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 6	-8.2 scores on scale	Standard Error 3.73
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	Week 4	-9.2 scores on scale	Standard Error 3.73

Comparison: Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.271995% CI: [-4.4, 15.6]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.69395% CI: [-7.9, 11.8]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.717895% CI: [-12.2, 8.4]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.803795% CI: [-11, 8.5]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.083295% CI: [-1.2, 18.6]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.355495% CI: [-5.4, 14.9]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.953895% CI: [-9.5, 10]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.559395% CI: [-13.4, 7.3]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.866395% CI: [-8.9, 10.6]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.11995% CI: [-2.1, 18.1]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.154495% CI: [-2.8, 17.5]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.843995% CI: [-8.8, 10.7]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.992595% CI: [-10.5, 10.4]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.878495% CI: [-9.1, 10.6]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.894895% CI: [-9.5, 10.8]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.219795% CI: [-3.9, 16.8]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.618395% CI: [-7.4, 12.5]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.448495% CI: [-14.8, 6.5]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.385795% CI: [-5.6, 14.4]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.882495% CI: [-11, 9.5]Mixed Models Analysis

Secondary

Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week

MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours of sleep per night.

Time frame: Week 1, Week 2, Week 4, Week 6

Population: ITT

Arm	Measure	Group	Value (NUMBER)
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 4	11 participants
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 2	8 participants
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 6	12 participants
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 1	6 participants
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 1	10 participants
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 6	11 participants
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 2	6 participants
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 4	12 participants
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 2	11 participants
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 1	7 participants
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 4	11 participants
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 6	11 participants
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 1	9 participants
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 2	9 participants
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 4	10 participants
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 6	10 participants
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 6	9 participants
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 4	14 participants
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 2	12 participants
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 1	6 participants
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 2	12 participants
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 1	11 participants
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 4	11 participants
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	Week 6	13 participants

Comparison: Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.064695% CI: [0.9, 15]Regression, Logistic

Comparison: Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.294795% CI: [0.5, 9.1]Regression, Logistic

Comparison: Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.024995% CI: [1.2, 17.2]Regression, Logistic

Comparison: Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.767195% CI: [0.3, 5.9]Regression, Logistic

Comparison: Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.016995% CI: [1.3, 15.9]Regression, Logistic

Comparison: Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.956995% CI: [0.2, 4.3]Regression, Logistic

Comparison: Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means.Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.071195% CI: [0.9, 11.4]Regression, Logistic

Comparison: Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.107395% CI: [0.8, 10.2]Regression, Logistic

Comparison: Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.158395% CI: [0.7, 8.1]Regression, Logistic

Comparison: Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.038595% CI: [1.1, 15.6]Regression, Logistic

Comparison: Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.492395% CI: [0.4, 6.1]Regression, Logistic

Comparison: Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.716995% CI: [0.4, 4.4]Regression, Logistic

Comparison: Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.415695% CI: [0.5, 6.2]Regression, Logistic

Comparison: Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.416595% CI: [0.5, 5.6]Regression, Logistic

Comparison: Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.467395% CI: [0.4, 6]Regression, Logistic

Comparison: Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.985595% CI: [0.2, 4.1]Regression, Logistic

Comparison: Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.956695% CI: [0.3, 3.3]Regression, Logistic

Comparison: Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.463295% CI: [0.4, 6.6]Regression, Logistic

Comparison: Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.204295% CI: [0.1, 1.6]Regression, Logistic

Comparison: Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.p-value: 0.338295% CI: [0.5, 7.5]Regression, Logistic

Secondary

Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Adequacy Subscale score range: 0-100; higher scores indicates greater sleep adequacy. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline, Week 1, Week 2, Week 4, Week 6

Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 1	5.2 scores on scale	Standard Error 5.38
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 2	15.6 scores on scale	Standard Error 5.38
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 4	15.6 scores on scale	Standard Error 5.45
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 6	16.8 scores on scale	Standard Error 5.54
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 4	23.9 scores on scale	Standard Error 5.78
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 2	31.0 scores on scale	Standard Error 5.87
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 1	16.1 scores on scale	Standard Error 5.76
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 6	34.6 scores on scale	Standard Error 5.87
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 2	19.6 scores on scale	Standard Error 5.45
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 4	20.8 scores on scale	Standard Error 5.38
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 6	27.0 scores on scale	Standard Error 5.45
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 1	5.3 scores on scale	Standard Error 5.53
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 1	13.7 scores on scale	Standard Error 6.01
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 6	26.8 scores on scale	Standard Error 6.17
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 2	21.9 scores on scale	Standard Error 6.06
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 4	24.7 scores on scale	Standard Error 6.06
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 1	9.8 scores on scale	Standard Error 5.5
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 4	26.6 scores on scale	Standard Error 5.53
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 2	14.0 scores on scale	Standard Error 5.53
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 6	19.2 scores on scale	Standard Error 5.53
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 2	29.5 scores on scale	Standard Error 5.76
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 1	16.1 scores on scale	Standard Error 5.58
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 4	34.6 scores on scale	Standard Error 5.78
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	Week 6	31.1 scores on scale	Standard Error 5.78

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.167395% CI: [-4.6, 26.4]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.983995% CI: [-15, 15.3]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.290595% CI: [-7.3, 24.4]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.551395% CI: [-10.6, 19.7]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.158995% CI: [-4.3, 26.3]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.054195% CI: [-0.3, 31]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.598795% CI: [-11, 19.1]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.437295% CI: [-9.6, 22.2]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.833695% CI: [-16.8, 13.6]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.080495% CI: [-1.7, 29.4]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.298595% CI: [-7.4, 23.9]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.499195% CI: [-9.9, 20.3]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.267595% CI: [-7, 25.1]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.159395% CI: [-4.3, 26.3]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.017995% CI: [3.3, 34.6]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.028195% CI: [1.9, 33.7]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.188395% CI: [-5, 25.5]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.2395% CI: [-6.3, 26.3]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.757595% CI: [-13, 17.8]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.075795% CI: [-1.5, 30.1]Mixed Models Analysis

Secondary

Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep quantity and quality over the past week; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Disturbance Subscale score (4 items): range 0-100; lower score indicates less disturbance. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline, Week 1, Week 2, Week 4, Week 6

Population: ITT, Baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 2	-15.7 scores on scale	Standard Error 4.76
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 4	-22.0 scores on scale	Standard Error 4.81
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 6	-19.3 scores on scale	Standard Error 4.87
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 1	-9.0 scores on scale	Standard Error 4.76
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 4	-18.5 scores on scale	Standard Error 5.07
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 2	-25.1 scores on scale	Standard Error 5.14
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 6	-29.2 scores on scale	Standard Error 5.14
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 1	-18.2 scores on scale	Standard Error 5.05
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 4	-28.3 scores on scale	Standard Error 4.76
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 2	-23.0 scores on scale	Standard Error 4.81
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 6	-25.3 scores on scale	Standard Error 4.81
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 1	-21.1 scores on scale	Standard Error 4.87
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 1	-23.0 scores on scale	Standard Error 5.26
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 6	-33.4 scores on scale	Standard Error 5.38
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 4	-32.4 scores on scale	Standard Error 5.3
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 2	-26.1 scores on scale	Standard Error 5.3
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 2	-35.3 scores on scale	Standard Error 4.95
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 1	-17.7 scores on scale	Standard Error 4.93
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 4	-34.2 scores on scale	Standard Error 4.95
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 6	-31.4 scores on scale	Standard Error 4.95
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 2	-32.1 scores on scale	Standard Error 5.02
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 1	-26.3 scores on scale	Standard Error 4.89
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 6	-40.2 scores on scale	Standard Error 5.02
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	Week 4	-37.4 scores on scale	Standard Error 5.02

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.182495% CI: [-23, 4.4]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.076795% CI: [-25.5, 1.3]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.049295% CI: [-28.1, -0.1]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.202395% CI: [-22.2, 4.7]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.011695% CI: [-30.9, -3.9]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.181995% CI: [-23.2, 4.4]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.280695% CI: [-20.6, 6]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.146595% CI: [-24.4, 3.7]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.004695% CI: [-33.1, -6.1]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.018795% CI: [-30, -2.8]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.612895% CI: [-10.2, 17.3]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.348895% CI: [-19.7, 7]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.147295% CI: [-24.5, 3.7]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.079195% CI: [-25.7, 1.4]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.028295% CI: [-29.1, -1.7]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.162395% CI: [-23.9, 4]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.373995% CI: [-19.6, 7.4]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.051795% CI: [-28.5, 0.1]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.081595% CI: [-25.8, 1.5]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.003195% CI: [-34.7, -7.1]Mixed Models Analysis

Secondary

Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Quantity (1 item) subscale score range: 0-24 hours. Change from Baseline in number of hours slept. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline,, Week 1, Week 2, Week 4, Week 6

Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 2	0.5 scores on scale	Standard Error 0.21
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 6	0.6 scores on scale	Standard Error 0.22
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 4	0.6 scores on scale	Standard Error 0.21
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 1	0.4 scores on scale	Standard Error 0.21
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 2	0.8 scores on scale	Standard Error 0.23
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 4	1.0 scores on scale	Standard Error 0.22
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 1	0.7 scores on scale	Standard Error 0.22
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 6	0.9 scores on scale	Standard Error 0.23
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 6	0.7 scores on scale	Standard Error 0.21
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 2	0.6 scores on scale	Standard Error 0.21
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 4	0.7 scores on scale	Standard Error 0.21
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 1	0.5 scores on scale	Standard Error 0.22
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 1	0.9 scores on scale	Standard Error 0.23
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 4	1.4 scores on scale	Standard Error 0.23
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 2	1.2 scores on scale	Standard Error 0.23
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 6	1.3 scores on scale	Standard Error 0.24
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 6	0.7 scores on scale	Standard Error 0.21
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 1	0.4 scores on scale	Standard Error 0.21
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 2	0.7 scores on scale	Standard Error 0.21
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 4	1.1 scores on scale	Standard Error 0.21
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 6	1.2 scores on scale	Standard Error 0.22
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 2	1.1 scores on scale	Standard Error 0.22
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 1	0.7 scores on scale	Standard Error 0.22
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	Week 4	1.1 scores on scale	Standard Error 0.22

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.297895% CI: [-0.3, 0.9]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.724295% CI: [-0.5, 0.7]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.077395% CI: [-0.1, 1.2]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.783195% CI: [-0.5, 0.7]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.329195% CI: [-0.3, 0.9]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.369295% CI: [-0.3, 0.9]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.761495% CI: [-0.5, 0.7]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.035595% CI: [0, 1.3]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.506895% CI: [-0.4, 0.8]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.056195% CI: [0, 1.2]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.222395% CI: [-0.2, 1]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.679195% CI: [-0.5, 0.7]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.018895% CI: [0.1, 1.4]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.131495% CI: [-0.1, 1.1]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.0995% CI: [-0.1, 1.1]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.414495% CI: [-0.4, 0.9]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.769995% CI: [-0.5, 0.7]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.040695% CI: [0, 1.3]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.757495% CI: [-0.5, 0.7]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.055495% CI: [0, 1.2]Mixed Models Analysis

Secondary

Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality over the past week. Comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Snoring Subscale score (1 item): range 0-100, lower score indicates less snoring. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline, Week 1, Week 2, Week 4, Week 6

Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 2	-1.5 scores on scale	Standard Error 5.39
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 1	-2.4 scores on scale	Standard Error 5.39
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 4	-3.2 scores on scale	Standard Error 5.44
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 6	-2.1 scores on scale	Standard Error 5.5
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 1	5.2 scores on scale	Standard Error 5.72
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 4	4.4 scores on scale	Standard Error 5.75
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 2	-0.8 scores on scale	Standard Error 5.81
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 6	2.5 scores on scale	Standard Error 5.81
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 2	-11.4 scores on scale	Standard Error 5.47
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 1	-8.6 scores on scale	Standard Error 5.53
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 6	-6.6 scores on scale	Standard Error 5.47
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 4	-4.0 scores on scale	Standard Error 5.42
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 4	-7.5 scores on scale	Standard Error 6.16
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 2	-8.7 scores on scale	Standard Error 6.16
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 1	0.7 scores on scale	Standard Error 6.04
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 6	-2.0 scores on scale	Standard Error 6.24
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 4	2.8 scores on scale	Standard Error 5.48
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 6	1.0 scores on scale	Standard Error 5.48
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 1	-2.9 scores on scale	Standard Error 5.46
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 2	-3.3 scores on scale	Standard Error 5.48
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 1	-9.2 scores on scale	Standard Error 5.54
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 2	-12.2 scores on scale	Standard Error 5.66
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 6	-7.5 scores on scale	Standard Error 5.67
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	Week 4	-3.5 scores on scale	Standard Error 5.67

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.336895% CI: [-8, 23.1]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.423295% CI: [-21.5, 9.1]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.708295% CI: [-12.9, 19]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.946695% CI: [-15.7, 14.7]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.374695% CI: [-22.1, 8.4]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.933695% CI: [-15, 16.3]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.202995% CI: [-25, 5.4]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.383395% CI: [-23.3, 9]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.815295% CI: [-17, 13.4]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.173995% CI: [-26.1, 4.7]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.339295% CI: [-8, 23.3]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.91395% CI: [-16, 14.4]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.695% CI: [-20.5, 11.9]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.444595% CI: [-9.3, 21.2]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.965695% CI: [-15.8, 15.1]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.567995% CI: [-11.2, 20.4]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.561995% CI: [-19.9, 10.8]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.99395% CI: [-16.3, 16.4]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.689295% CI: [-12.2, 18.5]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.492895% CI: [-21, 10.1]Mixed Models Analysis

Secondary

Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline

MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Somnolence Subscale score range: 0-100; higher score indicates less somnolence. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline,, Week 1, Week 2, Week 4, Week 6

Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 6	-11.7 scores on scale	Standard Error 4.12
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 2	-13.9 scores on scale	Standard Error 4.02
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 1	-7.4 scores on scale	Standard Error 4.02
Placebo	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 4	-14.0 scores on scale	Standard Error 4.07
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 6	-26.3 scores on scale	Standard Error 4.36
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 4	-20.4 scores on scale	Standard Error 4.3
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 2	-18.2 scores on scale	Standard Error 4.36
Pregabalin 50 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 1	-13.8 scores on scale	Standard Error 4.29
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 6	-14.8 scores on scale	Standard Error 4.07
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 4	-11.8 scores on scale	Standard Error 4.02
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 2	-11.1 scores on scale	Standard Error 4.07
Pregabalin 100 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 1	-9.8 scores on scale	Standard Error 4.12
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 4	-16.2 scores on scale	Standard Error 4.49
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 2	-18.8 scores on scale	Standard Error 4.49
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 1	-14.3 scores on scale	Standard Error 4.46
Pregabalin 150 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 6	-21.7 scores on scale	Standard Error 4.56
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 4	-16.9 scores on scale	Standard Error 4.09
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 2	-11.3 scores on scale	Standard Error 4.09
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 1	-11.2 scores on scale	Standard Error 4.07
Pregabalin 300 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 6	-13.4 scores on scale	Standard Error 4.09
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 6	-13.9 scores on scale	Standard Error 4.26
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 4	-12.6 scores on scale	Standard Error 4.26
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 2	-12.6 scores on scale	Standard Error 4.25
Pregabalin 450 mg	Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	Week 1	-10.7 scores on scale	Standard Error 4.14

Comparison: Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.281795% CI: [-18, 5.2]Mixed Models Analysis

Comparison: Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.679695% CI: [-13.7, 9]Mixed Models Analysis

Comparison: Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.250595% CI: [-18.8, 4.9]Mixed Models Analysis

Comparison: Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.510295% CI: [-15.1, 7.5]Mixed Models Analysis

Comparison: Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.570695% CI: [-14.7, 8.1]Mixed Models Analysis

Comparison: Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.470895% CI: [-16, 7.4]Mixed Models Analysis

Comparison: Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.620295% CI: [-8.4, 14.1]Mixed Models Analysis

Comparison: Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.417795% CI: [-16.8, 7]Mixed Models Analysis

Comparison: Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.650995% CI: [-8.7, 13.9]Mixed Models Analysis

Comparison: Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.827395% CI: [-10.3, 12.8]Mixed Models Analysis

Comparison: Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.284295% CI: [-18.1, 5.3]Mixed Models Analysis

Comparison: Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.704195% CI: [-9.1, 13.5]Mixed Models Analysis

Comparison: Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.721695% CI: [-14.1, 9.8]Mixed Models Analysis

Comparison: Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.618895% CI: [-14.3, 8.5]Mixed Models Analysis

Comparison: Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.809695% CI: [-10.2, 13]Mixed Models Analysis

Comparison: Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.015795% CI: [-26.5, -2.8]Mixed Models Analysis

Comparison: Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.600795% CI: [-14.4, 8.4]Mixed Models Analysis

Comparison: Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.105795% CI: [-22.1, 2.1]Mixed Models Analysis

Comparison: Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.776495% CI: [-13.1, 9.8]Mixed Models Analysis

Comparison: Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.714695% CI: [-13.9, 9.5]Mixed Models Analysis

Secondary

Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)

Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 6 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.

Time frame: Week 6

Population: ITT; N=number of subjects in a treatment group; n=number of subjects with a clinical Global Impressions Improvement (CGI-I) rating.

Arm	Measure	Group	Value (NUMBER)
Placebo	Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	Week 6: Responders (n=21, 20, 22, 18, 23, 20)	13 participants
Placebo	Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	Week 6: Non-Responders	8 participants
Pregabalin 50 mg	Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	Week 6: Responders (n=21, 20, 22, 18, 23, 20)	12 participants
Pregabalin 50 mg	Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	Week 6: Non-Responders	8 participants
Pregabalin 100 mg	Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	Week 6: Responders (n=21, 20, 22, 18, 23, 20)	15 participants
Pregabalin 100 mg	Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	Week 6: Non-Responders	7 participants
Pregabalin 150 mg	Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	Week 6: Responders (n=21, 20, 22, 18, 23, 20)	11 participants
Pregabalin 150 mg	Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	Week 6: Non-Responders	7 participants
Pregabalin 300 mg	Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	Week 6: Responders (n=21, 20, 22, 18, 23, 20)	17 participants
Pregabalin 300 mg	Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	Week 6: Non-Responders	6 participants
Pregabalin 450 mg	Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	Week 6: Responders (n=21, 20, 22, 18, 23, 20)	18 participants
Pregabalin 450 mg	Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	Week 6: Non-Responders	2 participants

Comparison: Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.8784Cochran-Mantel-Haenszel

Comparison: Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.6767Cochran-Mantel-Haenszel

Comparison: Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.8955Cochran-Mantel-Haenszel

Comparison: Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.9505Cochran-Mantel-Haenszel

Comparison: Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.0466Cochran-Mantel-Haenszel

Secondary

Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)

CGI-S Scale: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.

Time frame: Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)

Population: ITT; N=number of subjects in a treatment group. LOCF: Last Observation Carried Forward.

Arm	Measure	Group	Value (NUMBER)
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Severely Ill	3 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Markedly Ill	2 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Normal, Not at All Ill	1 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Mildly Ill	12 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Among the Most Extremely Ill	0 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Borderline, Mentally Ill	0 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Normal	1 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Severely Ill	4 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Borderline, Mentally Ill	0 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Severely Ill	2 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Markedly Ill	2 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Markedly Ill	3 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Moderately Ill	4 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Among the Most Extremely Ill	0 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Mildly Ill	4 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Borderline, Mentally Ill	4 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Among the Most Extremely Ill	1 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Markedly Ill	4 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Severely Ill	2 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Borderline, Mentally Ill	3 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Moderately Ill	10 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Normal, Not at All Ill	0 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Moderately Ill	3 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Normal, Not at All Ill	1 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Markedly Ill	3 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Moderately Ill	6 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Markedly Ill	7 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Among the Most Extremely Ill	1 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Mildly Ill	11 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Mildly Ill	10 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Borderline, Mentally Ill	3 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Borderline, Mentally Ill	3 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Severely Ill	8 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Severely Ill	2 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Moderately Ill	2 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Normal, Not at All Ill	0 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Normal, Not at All Ill	1 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Moderately Ill	2 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Among the Most Extremely Ill	1 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Mildly Ill	8 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Mildly Ill	1 participants
Placebo	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Among the Most Extremely Ill	0 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Moderately Ill	8 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Normal, Not at All Ill	2 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Moderately Ill	9 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Among the Most Extremely Ill	0 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Borderline, Mentally Ill	2 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Severely Ill	2 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Mildly Ill	7 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Moderately Ill	6 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Markedly Ill	2 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Borderline, Mentally Ill	3 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Markedly Ill	8 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Severely Ill	3 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Normal	3 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Among the Most Extremely Ill	1 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Among the Most Extremely Ill	0 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Markedly Ill	2 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Normal, Not at All Ill	1 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Borderline, Mentally Ill	1 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Borderline, Mentally Ill	0 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Among the Most Extremely Ill	0 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Mildly Ill	6 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Severely Ill	1 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Markedly Ill	3 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Markedly Ill	2 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Severely Ill	2 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Moderately Ill	5 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Among the Most Extremely Ill	0 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Normal, Not at All Ill	2 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Mildly Ill	1 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Moderately Ill	6 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Borderline, Mentally Ill	4 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Markedly Ill	3 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Mildly Ill	6 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Mildly Ill	5 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Normal, Not at All Ill	0 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Moderately Ill	5 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Borderline, Mentally Ill	3 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Severely Ill	2 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Mildly Ill	6 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Severely Ill	1 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Normal, Not at All Ill	3 participants
Pregabalin 50 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Among the Most Extremely Ill	0 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Markedly Ill	2 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Moderately Ill	5 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Among the Most Extremely Ill	0 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Markedly Ill	1 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Normal, Not at All Ill	1 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Moderately Ill	8 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Normal, Not at All Ill	2 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Severely Ill	6 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Normal	4 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Normal, Not at All Ill	0 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Borderline, Mentally Ill	2 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Mildly Ill	11 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Mildly Ill	7 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Mildly Ill	2 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Mildly Ill	7 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Among the Most Extremely Ill	0 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Markedly Ill	4 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Severely Ill	1 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Mildly Ill	9 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Severely Ill	1 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Markedly Ill	7 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Borderline, Mentally Ill	4 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Moderately Ill	5 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Among the Most Extremely Ill	0 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Severely Ill	0 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Markedly Ill	2 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Borderline, Mentally Ill	0 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Borderline, Mentally Ill	4 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Markedly Ill	5 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Mildly Ill	5 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Normal, Not at All Ill	4 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Borderline, Mentally Ill	1 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Among the Most Extremely Ill	0 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Moderately Ill	5 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Severely Ill	3 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Severely Ill	1 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Moderately Ill	5 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Borderline, Mentally Ill	2 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Normal, Not at All Ill	1 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Moderately Ill	6 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Among the Most Extremely Ill	0 participants
Pregabalin 100 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Among the Most Extremely Ill	0 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Moderately Ill	6 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Normal, Not at All Ill	0 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Borderline, Mentally Ill	0 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Mildly Ill	4 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Moderately Ill	5 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Markedly Ill	5 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Severely Ill	7 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Among the Most Extremely Ill	1 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Normal, Not at All Ill	1 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Borderline, Mentally Ill	1 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Mildly Ill	8 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Moderately Ill	7 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Markedly Ill	1 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Severely Ill	2 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Among the Most Extremely Ill	0 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Normal, Not at All Ill	2 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Borderline, Mentally Ill	3 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Mildly Ill	7 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Markedly Ill	0 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Severely Ill	1 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Among the Most Extremely Ill	0 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Normal, Not at All Ill	5 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Borderline, Mentally Ill	2 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Mildly Ill	5 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Moderately Ill	5 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Markedly Ill	1 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Severely Ill	1 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Among the Most Extremely Ill	0 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Normal, Not at All Ill	4 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Moderately Ill	5 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Borderline, Mentally Ill	4 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Mildly Ill	9 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Mildly Ill	7 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Moderately Ill	3 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Markedly Ill	0 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Severely Ill	0 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Among the Most Extremely Ill	0 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Markedly Ill	0 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Normal	4 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Borderline, Mentally Ill	4 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Severely Ill	0 participants
Pregabalin 150 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Among the Most Extremely Ill	0 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Among the Most Extremely Ill	0 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Among the Most Extremely Ill	0 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Severely Ill	1 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Normal, Not at All Ill	6 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Markedly Ill	3 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Moderately Ill	5 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Borderline, Mentally Ill	4 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Mildly Ill	4 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Borderline, Mentally Ill	6 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Borderline, Mentally Ill	4 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Mildly Ill	2 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Mildly Ill	7 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Normal, Not at All Ill	3 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Mildly Ill	7 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Among the Most Extremely Ill	0 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Severely Ill	5 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Among the Most Extremely Ill	0 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Moderately Ill	1 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Markedly Ill	3 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Severely Ill	2 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Markedly Ill	4 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Moderately Ill	6 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Mildly Ill	5 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Severely Ill	1 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Borderline, Mentally Ill	4 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Borderline, Mentally Ill	0 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Among the Most Extremely Ill	0 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Normal, Not at All Ill	0 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Moderately Ill	1 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Among the Most Extremely Ill	0 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Markedly Ill	4 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Severely Ill	8 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Normal, Not at All Ill	0 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Normal	6 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Moderately Ill	5 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Markedly Ill	3 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Markedly Ill	2 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Mildly Ill	4 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Borderline, Mentally Ill	6 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Severely Ill	2 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Normal, Not at All Ill	4 participants
Pregabalin 300 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Moderately Ill	11 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Markedly Ill	5 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Mildly Ill	7 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Severely Ill	0 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Borderline, Mentally Ill	5 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Among the Most Extremely Ill	0 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Severely Ill	1 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Markedly Ill	1 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Borderline, Mentally Ill	6 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Markedly Ill	0 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Among the Most Extremely Ill	0 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Normal, Not at All Ill	7 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Moderately Ill	3 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Severely Ill	0 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Mildly Ill	8 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Mildly Ill	2 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Borderline, Mentally Ill	2 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Borderline, Mentally Ill	5 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Normal	7 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Borderline, Mentally Ill	2 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Normal, Not at All Ill	3 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Moderately Ill	2 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Moderately Ill	6 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Among the Most Extremely Ill	0 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Mildly Ill	7 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Normal, Not at All Ill	7 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Mildly Ill	4 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Among the Most Extremely Ill	0 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Borderline, Mentally Ill	0 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 2: Among the Most Extremely Ill	0 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Mildly Ill	6 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	LOCF: Moderately Ill	1 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Severely Ill	1 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Among the Most Extremely Ill	0 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Severely Ill	0 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Severely Ill	10 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Moderately Ill	1 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Markedly Ill	2 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Baseline: Normal, Not at All Ill	0 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 1: Moderately Ill	8 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Markedly Ill	1 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 4: Normal, Not at All Ill	8 participants
Pregabalin 450 mg	Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	Week 6: Markedly Ill	1 participants

Comparison: Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.3876Cochran-Mantel-Haenszel

Comparison: Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.7959Cochran-Mantel-Haenszel

Comparison: Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.2032Cochran-Mantel-Haenszel

Comparison: Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.7032Cochran-Mantel-Haenszel

Comparison: Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.0551Cochran-Mantel-Haenszel

Comparison: Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.41Cochran-Mantel-Haenszel

Comparison: Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.6524Cochran-Mantel-Haenszel

Comparison: Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.3219Cochran-Mantel-Haenszel

Comparison: Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.3509Cochran-Mantel-Haenszel

Comparison: Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.0053Cochran-Mantel-Haenszel

Comparison: Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.9835Cochran-Mantel-Haenszel

Comparison: Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.6668Cochran-Mantel-Haenszel

Comparison: Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.2823Cochran-Mantel-Haenszel

Comparison: Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.5687Cochran-Mantel-Haenszel

Comparison: Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.0043Cochran-Mantel-Haenszel

Comparison: Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.8662Cochran-Mantel-Haenszel

Comparison: Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.3656Cochran-Mantel-Haenszel

Comparison: Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.0806Cochran-Mantel-Haenszel

Comparison: Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.5381Cochran-Mantel-Haenszel

Comparison: Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.009Cochran-Mantel-Haenszel

Comparison: Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.9748Cochran-Mantel-Haenszel

Comparison: Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.3936Cochran-Mantel-Haenszel

Comparison: Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.1563Cochran-Mantel-Haenszel

Comparison: Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.6357Cochran-Mantel-Haenszel

Comparison: Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.p-value: 0.0133Cochran-Mantel-Haenszel

Secondary

Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6

RLS QoL: subject-rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period is the month prior to the assessment. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline, Week 6

Population: ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, and had baseline and post-baseline values.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6	15.0 scores on scales	Standard Error 3.71
Pregabalin 50 mg	Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6	19.6 scores on scales	Standard Error 3.87
Pregabalin 100 mg	Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6	22.4 scores on scales	Standard Error 3.55
Pregabalin 150 mg	Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6	20.8 scores on scales	Standard Error 3.94
Pregabalin 300 mg	Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6	15.9 scores on scales	Standard Error 3.63
Pregabalin 450 mg	Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6	20.5 scores on scales	Standard Error 3.74

Comparison: Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.393295% CI: [-6, 15.2]ANCOVA

Comparison: Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.158595% CI: [-2.9, 17.5]ANCOVA

Comparison: Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.28595% CI: [-4.9, 16.5]ANCOVA

Comparison: Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.864595% CI: [-9.4, 11.1]ANCOVA

Comparison: Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.p-value: 0.303195% CI: [-5, 15.8]ANCOVA

Secondary

Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Hours of sleep subscale reflects change in hours of sleep from baseline. Numerical rating completed by the subject 30 minutes after waking; recall period is the night before.

Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Population: ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 1	0.23 hours	Standard Error 0.177
Placebo	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 2	0.36 hours	Standard Error 0.177
Placebo	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 4	0.27 hours	Standard Error 0.18
Placebo	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 5	0.37 hours	Standard Error 0.182
Placebo	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 3	0.36 hours	Standard Error 0.182
Placebo	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 6	0.19 hours	Standard Error 0.182
Pregabalin 50 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 2	0.65 hours	Standard Error 0.186
Pregabalin 50 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 5	1.03 hours	Standard Error 0.188
Pregabalin 50 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 4	0.81 hours	Standard Error 0.188
Pregabalin 50 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 1	0.57 hours	Standard Error 0.183
Pregabalin 50 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 6	0.84 hours	Standard Error 0.188
Pregabalin 50 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 3	0.61 hours	Standard Error 0.188
Pregabalin 100 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 1	0.29 hours	Standard Error 0.177
Pregabalin 100 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 3	0.53 hours	Standard Error 0.177
Pregabalin 100 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 6	0.42 hours	Standard Error 0.179
Pregabalin 100 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 5	0.43 hours	Standard Error 0.177
Pregabalin 100 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 4	0.46 hours	Standard Error 0.177
Pregabalin 100 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 2	0.52 hours	Standard Error 0.179
Pregabalin 150 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 6	0.95 hours	Standard Error 0.198
Pregabalin 150 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 1	0.55 hours	Standard Error 0.182
Pregabalin 150 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 3	0.89 hours	Standard Error 0.192
Pregabalin 150 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 2	0.81 hours	Standard Error 0.192
Pregabalin 150 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 4	0.93 hours	Standard Error 0.192
Pregabalin 150 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 5	0.97 hours	Standard Error 0.195
Pregabalin 300 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 2	0.76 hours	Standard Error 0.18
Pregabalin 300 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 5	0.61 hours	Standard Error 0.18
Pregabalin 300 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 6	0.44 hours	Standard Error 0.18
Pregabalin 300 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 4	0.65 hours	Standard Error 0.18
Pregabalin 300 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 3	0.72 hours	Standard Error 0.18
Pregabalin 300 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 1	0.45 hours	Standard Error 0.177
Pregabalin 450 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 2	1.07 hours	Standard Error 0.181
Pregabalin 450 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 6	1.11 hours	Standard Error 0.187
Pregabalin 450 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 4	1.03 hours	Standard Error 0.187
Pregabalin 450 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 3	1.32 hours	Standard Error 0.189
Pregabalin 450 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 1	0.72 hours	Standard Error 0.178
Pregabalin 450 mg	Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	Week 5	1.43 hours	Standard Error 0.187

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.171595% CI: [-0.15, 0.85]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.794495% CI: [-0.43, 0.56]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.199495% CI: [-0.17, 0.83]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.365295% CI: [-0.27, 0.72]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.048195% CI: [0, 0.99]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.250195% CI: [-0.21, 0.8]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.519195% CI: [-0.33, 0.66]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.081795% CI: [-0.06, 0.97]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.114695% CI: [-0.1, 0.9]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.005495% CI: [0.21, 1.21]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.338995% CI: [-0.26, 0.76]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.507995% CI: [-0.33, 0.67]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.045395% CI: [0.01, 1.05]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.162295% CI: [-0.15, 0.86]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.000395% CI: [0.45, 1.48]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.038395% CI: [0.03, 1.05]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.449595% CI: [-0.31, 0.69]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.013595% CI: [0.14, 1.17]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.142395% CI: [-0.13, 0.87]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.003595% CI: [0.25, 1.27]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.012595% CI: [0.14, 1.17]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.802195% CI: [-0.44, 0.56]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.024995% CI: [0.08, 1.13]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.338395% CI: [-0.26, 0.75]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.000195% CI: [0.55, 1.57]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.013395% CI: [0.14, 1.17]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.38295% CI: [-0.28, 0.73]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.005395% CI: [0.23, 1.28]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.325895% CI: [-0.25, 0.76]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.000595% CI: [0.41, 1.43]Mixed Models Analysis

Secondary

Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Number of awakenings subscale: numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Fewer awakenings reflect better quality of sleep. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Population: ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline in at least one post-baseline visit.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 2	-0.7 awakenings	Standard Error 0.21
Placebo	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 5	-0.8 awakenings	Standard Error 0.21
Placebo	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 4	-0.9 awakenings	Standard Error 0.21
Placebo	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 6	-1.0 awakenings	Standard Error 0.21
Placebo	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 1	-0.5 awakenings	Standard Error 0.21
Placebo	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 3	-0.7 awakenings	Standard Error 0.21
Pregabalin 50 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 2	-1.0 awakenings	Standard Error 0.22
Pregabalin 50 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 5	-1.3 awakenings	Standard Error 0.22
Pregabalin 50 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 3	-1.0 awakenings	Standard Error 0.22
Pregabalin 50 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 6	-1.0 awakenings	Standard Error 0.22
Pregabalin 50 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 4	-1.1 awakenings	Standard Error 0.22
Pregabalin 50 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 1	-0.9 awakenings	Standard Error 0.21
Pregabalin 100 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 1	-1.0 awakenings	Standard Error 0.21
Pregabalin 100 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 5	-1.0 awakenings	Standard Error 0.21
Pregabalin 100 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 4	-1.2 awakenings	Standard Error 0.21
Pregabalin 100 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 3	-1.0 awakenings	Standard Error 0.21
Pregabalin 100 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 6	-1.1 awakenings	Standard Error 0.21
Pregabalin 100 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 2	-1.3 awakenings	Standard Error 0.21
Pregabalin 150 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 5	-1.6 awakenings	Standard Error 0.23
Pregabalin 150 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 6	-1.5 awakenings	Standard Error 0.23
Pregabalin 150 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 1	-1.2 awakenings	Standard Error 0.21
Pregabalin 150 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 2	-1.3 awakenings	Standard Error 0.23
Pregabalin 150 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 3	-1.3 awakenings	Standard Error 0.23
Pregabalin 150 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 4	-1.5 awakenings	Standard Error 0.23
Pregabalin 300 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 2	-1.3 awakenings	Standard Error 0.21
Pregabalin 300 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 5	-1.2 awakenings	Standard Error 0.21
Pregabalin 300 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 3	-1.2 awakenings	Standard Error 0.21
Pregabalin 300 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 1	-0.7 awakenings	Standard Error 0.21
Pregabalin 300 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 6	-1.0 awakenings	Standard Error 0.21
Pregabalin 300 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 4	-1.1 awakenings	Standard Error 0.21
Pregabalin 450 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 2	-1.1 awakenings	Standard Error 0.21
Pregabalin 450 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 1	-0.8 awakenings	Standard Error 0.21
Pregabalin 450 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 4	-1.2 awakenings	Standard Error 0.22
Pregabalin 450 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 3	-1.4 awakenings	Standard Error 0.22
Pregabalin 450 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 5	-1.5 awakenings	Standard Error 0.22
Pregabalin 450 mg	Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	Week 6	-1.2 awakenings	Standard Error 0.22

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.142995% CI: [-1, 0.1]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.054795% CI: [-1.2, 0]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.009595% CI: [-1.4, -0.2]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.367695% CI: [-0.9, 0.3]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.295995% CI: [-0.9, 0.3]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.343595% CI: [-0.9, 0.3]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.089595% CI: [-1.1, 0.1]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.084495% CI: [-1.1, 0.1]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.067595% CI: [-1.1, 0]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.22595% CI: [-1, 0.2]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.372895% CI: [-0.9, 0.3]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.268695% CI: [-0.9, 0.3]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.075395% CI: [-1.2, 0.1]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.133595% CI: [-1, 0.1]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.02295% CI: [-1.3, -0.1]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.575495% CI: [-0.8, 0.4]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.34895% CI: [-0.9, 0.3]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.055495% CI: [-1.2, 0]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.436295% CI: [-0.8, 0.4]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.363195% CI: [-0.9, 0.3]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.115295% CI: [-1.1, 0.1]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.474195% CI: [-0.8, 0.4]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.009195% CI: [-1.4, -0.2]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.172195% CI: [-1, 0.2]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.026295% CI: [-1.3, -0.1]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.950595% CI: [-0.6, 0.6]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.687795% CI: [-0.7, 0.5]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.127195% CI: [-1.1, 0.1]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.913695% CI: [-0.6, 0.6]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.407295% CI: [-0.9, 0.3]Mixed Models Analysis

Secondary

Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Quality of sleep subscale: visual analog scale ranging from 1 (very poor) to 100 (excellent) completed by the subject 30 minutes after waking; recall period is the night before. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 2	11.3 scores on scale	Standard Error 4.1
Placebo	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 4	13.2 scores on scale	Standard Error 4.14
Placebo	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 3	13.8 scores on scale	Standard Error 4.17
Placebo	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 1	5.0 scores on scale	Standard Error 4.1
Placebo	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 6	13.9 scores on scale	Standard Error 4.17
Placebo	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 5	14.7 scores on scale	Standard Error 4.17
Pregabalin 50 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 6	27.6 scores on scale	Standard Error 4.31
Pregabalin 50 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 4	23.8 scores on scale	Standard Error 4.31
Pregabalin 50 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 2	23.3 scores on scale	Standard Error 4.27
Pregabalin 50 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 5	28.7 scores on scale	Standard Error 4.31
Pregabalin 50 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 3	23.0 scores on scale	Standard Error 4.31
Pregabalin 50 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 1	18.8 scores on scale	Standard Error 4.21
Pregabalin 100 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 2	18.7 scores on scale	Standard Error 4.13
Pregabalin 100 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 3	18.6 scores on scale	Standard Error 4.1
Pregabalin 100 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 4	22.0 scores on scale	Standard Error 4.1
Pregabalin 100 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 6	23.5 scores on scale	Standard Error 4.14
Pregabalin 100 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 1	15.2 scores on scale	Standard Error 4.1
Pregabalin 100 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 5	19.9 scores on scale	Standard Error 4.1
Pregabalin 150 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 6	30.5 scores on scale	Standard Error 4.5
Pregabalin 150 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 5	30.9 scores on scale	Standard Error 4.45
Pregabalin 150 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 1	15.9 scores on scale	Standard Error 4.23
Pregabalin 150 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 2	24.2 scores on scale	Standard Error 4.4
Pregabalin 150 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 3	26.8 scores on scale	Standard Error 4.4
Pregabalin 150 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 4	28.2 scores on scale	Standard Error 4.4
Pregabalin 300 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 2	23.4 scores on scale	Standard Error 4.2
Pregabalin 300 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 3	23.6 scores on scale	Standard Error 4.2
Pregabalin 300 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 1	11.5 scores on scale	Standard Error 4.16
Pregabalin 300 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 6	23.1 scores on scale	Standard Error 4.2
Pregabalin 300 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 4	24.2 scores on scale	Standard Error 4.2
Pregabalin 300 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 5	26.0 scores on scale	Standard Error 4.2
Pregabalin 450 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 2	24.0 scores on scale	Standard Error 4.16
Pregabalin 450 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 4	23.8 scores on scale	Standard Error 4.25
Pregabalin 450 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 3	25.4 scores on scale	Standard Error 4.29
Pregabalin 450 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 1	17.2 scores on scale	Standard Error 4.11
Pregabalin 450 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 6	28.8 scores on scale	Standard Error 4.25
Pregabalin 450 mg	Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	Week 5	31.1 scores on scale	Standard Error 4.25

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.019995% CI: [2.2, 25.4]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.076895% CI: [-1.1, 21.7]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.064295% CI: [-0.7, 22.6]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.264395% CI: [-5, 18.2]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.035895% CI: [0.8, 23.7]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.042895% CI: [0.4, 23.8]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.199395% CI: [-4, 18.9]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.033195% CI: [1.1, 24.8]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.041595% CI: [0.5, 23.8]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.029595% CI: [1.3, 24.3]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.126795% CI: [-2.6, 21.1]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.417595% CI: [-6.8, 16.2]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.034295% CI: [1, 25]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.103895% CI: [-2, 21.5]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.053795% CI: [-0.2, 23.4]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.077295% CI: [-1.2, 22.4]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.129695% CI: [-2.6, 20.3]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.01495% CI: [3.1, 27]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.064295% CI: [-0.7, 22.7]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.07395% CI: [-1, 22.3]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.021595% CI: [2.1, 25.8]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.378595% CI: [-6.4, 16.7]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.008995% CI: [4.1, 28.2]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.060995% CI: [-0.5, 23]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.006495% CI: [4.7, 28.1]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.024195% CI: [1.8, 25.5]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.103295% CI: [-2, 21.1]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.007695% CI: [4.4, 28.7]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.125795% CI: [-2.6, 20.9]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.013195% CI: [3.2, 26.6]Mixed Models Analysis

Secondary

Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Latency subscale (time to fall asleep \[in minutes\]): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Lower score reflects greater ease (shorter time) in falling asleep. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 1	-9.8 minutes	Standard Error 5.6
Placebo	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 6	-12.4 minutes	Standard Error 5.71
Placebo	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 4	-13.6 minutes	Standard Error 5.66
Placebo	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 5	-15.9 minutes	Standard Error 5.71
Placebo	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 3	-14.6 minutes	Standard Error 5.71
Placebo	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 2	-8.9 minutes	Standard Error 5.6
Pregabalin 50 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 3	-18.9 minutes	Standard Error 5.9
Pregabalin 50 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 5	-26.8 minutes	Standard Error 5.9
Pregabalin 50 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 6	-25.4 minutes	Standard Error 5.9
Pregabalin 50 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 1	-16.3 minutes	Standard Error 5.76
Pregabalin 50 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 2	-20.7 minutes	Standard Error 5.84
Pregabalin 50 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 4	-20.4 minutes	Standard Error 5.9
Pregabalin 100 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 4	-20.4 minutes	Standard Error 5.6
Pregabalin 100 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 2	-17.2 minutes	Standard Error 5.65
Pregabalin 100 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 5	-17.6 minutes	Standard Error 5.6
Pregabalin 100 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 6	-19.5 minutes	Standard Error 5.65
Pregabalin 100 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 3	-13.1 minutes	Standard Error 5.6
Pregabalin 100 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 1	-13.2 minutes	Standard Error 5.6
Pregabalin 150 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 2	-16.3 minutes	Standard Error 6
Pregabalin 150 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 5	-24.0 minutes	Standard Error 6.07
Pregabalin 150 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 1	-10.4 minutes	Standard Error 5.76
Pregabalin 150 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 6	-25.1 minutes	Standard Error 6.14
Pregabalin 150 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 3	-17.8 minutes	Standard Error 6
Pregabalin 150 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 4	-18.2 minutes	Standard Error 6
Pregabalin 300 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 1	-9.1 minutes	Standard Error 5.65
Pregabalin 300 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 2	-13.0 minutes	Standard Error 5.71
Pregabalin 300 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 6	-10.1 minutes	Standard Error 5.71
Pregabalin 300 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 3	-17.8 minutes	Standard Error 5.71
Pregabalin 300 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 4	-18.2 minutes	Standard Error 5.71
Pregabalin 300 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 5	-13.4 minutes	Standard Error 5.71
Pregabalin 450 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 2	-34.3 minutes	Standard Error 5.69
Pregabalin 450 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 6	-34.9 minutes	Standard Error 5.82
Pregabalin 450 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 5	-36.1 minutes	Standard Error 5.82
Pregabalin 450 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 1	-20.2 minutes	Standard Error 5.62
Pregabalin 450 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 3	-33.7 minutes	Standard Error 5.88
Pregabalin 450 mg	Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	Week 4	-37.1 minutes	Standard Error 5.82

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.413395% CI: [-22.4, 9.3]Mixed Models Analysis

Comparison: Week 1: Conrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.667695% CI: [-19, 12.2]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.935595% CI: [-16.5, 15.2]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.935595% CI: [-15.1, 16.4]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.189595% CI: [-26.1, 5.2]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.144395% CI: [-27.8, 4.1]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.294695% CI: [-24, 7.3]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.368695% CI: [-23.6, 8.8]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.607995% CI: [-19.9, 11.7]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.001695% CI: [-41.2, -9.7]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.597695% CI: [-20.5, 11.8]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.852795% CI: [-14.3, 17.3]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.697395% CI: [-19.6, 13.1]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.689595% CI: [-19.2, 12.7]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.020995% CI: [-35.2, -2.9]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.408495% CI: [-22.9, 9.3]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.395895% CI: [-22.5, 8.9]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.577695% CI: [-20.9, 11.7]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.566595% CI: [-20.5, 11.3]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.004195% CI: [-39.6, -7.5]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.184295% CI: [-27.1, 5.2]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.826995% CI: [-17.5, 14]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.331995% CI: [-24.5, 8.3]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.755295% CI: [-13.4, 18.5]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.013795% CI: [-36.3, -4.2]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.115795% CI: [-29.2, 3.2]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.379195% CI: [-22.9, 8.7]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.132995% CI: [-29.2, 3.9]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.772395% CI: [-13.6, 18.3]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.006395% CI: [-38.6, -6.4]Mixed Models Analysis

Secondary

Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Total wake time after sleep onset subscale (in minutes): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Reduction = improvement. Change from baseline = score at observation minus score at baseline.

Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Population: ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 5	-28.7 minutes	Standard Error 7.62
Placebo	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 2	-29.5 minutes	Standard Error 7.44
Placebo	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 3	-34.3 minutes	Standard Error 7.62
Placebo	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 1	-23.8 minutes	Standard Error 7.44
Placebo	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 4	-30.4 minutes	Standard Error 7.53
Placebo	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 6	-34.2 minutes	Standard Error 7.62
Pregabalin 50 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 2	-47.0 minutes	Standard Error 7.79
Pregabalin 50 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 6	-57.0 minutes	Standard Error 7.9
Pregabalin 50 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 5	-55.4 minutes	Standard Error 8.01
Pregabalin 50 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 1	-37.9 minutes	Standard Error 7.66
Pregabalin 50 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 3	-51.4 minutes	Standard Error 8.01
Pregabalin 50 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 4	-50.7 minutes	Standard Error 8.01
Pregabalin 100 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 3	-32.0 minutes	Standard Error 7.47
Pregabalin 100 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 4	-36.5 minutes	Standard Error 7.47
Pregabalin 100 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 5	-30.7 minutes	Standard Error 7.47
Pregabalin 100 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 2	-36.5 minutes	Standard Error 7.55
Pregabalin 100 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 1	-28.5 minutes	Standard Error 7.47
Pregabalin 100 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 6	-34.2 minutes	Standard Error 7.55
Pregabalin 150 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 3	-45.9 minutes	Standard Error 8.23
Pregabalin 150 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 2	-41.9 minutes	Standard Error 8.23
Pregabalin 150 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 5	-59.6 minutes	Standard Error 8.36
Pregabalin 150 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 1	-29.0 minutes	Standard Error 7.81
Pregabalin 150 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 4	-46.0 minutes	Standard Error 8.23
Pregabalin 150 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 6	-54.0 minutes	Standard Error 8.49
Pregabalin 300 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 6	-41.1 minutes	Standard Error 7.68
Pregabalin 300 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 2	-39.8 minutes	Standard Error 7.68
Pregabalin 300 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 5	-42.5 minutes	Standard Error 7.59
Pregabalin 300 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 1	-32.2 minutes	Standard Error 7.58
Pregabalin 300 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 4	-43.6 minutes	Standard Error 7.68
Pregabalin 300 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 3	-42.3 minutes	Standard Error 7.59
Pregabalin 450 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 6	-55.5 minutes	Standard Error 7.89
Pregabalin 450 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 1	-32.6 minutes	Standard Error 7.46
Pregabalin 450 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 2	-46.3 minutes	Standard Error 7.57
Pregabalin 450 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 3	-42.9 minutes	Standard Error 7.89
Pregabalin 450 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 5	-55.1 minutes	Standard Error 7.79
Pregabalin 450 mg	Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	Week 4	-46.8 minutes	Standard Error 7.79

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.18695% CI: [-35.2, 6.9]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.65395% CI: [-25.5, 16]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.626395% CI: [-26.5, 16]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.426695% CI: [-29.4, 12.5]Mixed Models Analysis

Comparison: Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.402395% CI: [-29.6, 11.9]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.104195% CI: [-38.8, 3.6]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.508495% CI: [-27.9, 13.8]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.26295% CI: [-34.3, 9.4]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.334795% CI: [-31.4, 10.7]Mixed Models Analysis

Comparison: Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.114295% CI: [-37.7, 4.1]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.123795% CI: [-38.8, 4.7]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.830295% CI: [-18.7, 23.3]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.303995% CI: [-33.6, 10.5]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.459595% CI: [-29.2, 13.2]Mixed Models Analysis

Comparison: Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.433895% CI: [-30.2, 13]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.064795% CI: [-42, 1.2]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.565195% CI: [-27, 14.8]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.163495% CI: [-37.6, 6.4]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.220995% CI: [-34.4, 8]Mixed Models Analysis

Comparison: Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.129395% CI: [-37.8, 4.8]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.016195% CI: [-48.5, -5]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.850695% CI: [-23, 19]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.006795% CI: [-53.2, -8.6]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.199795% CI: [-35, 7.4]Mixed Models Analysis

Comparison: Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.015995% CI: [-47.9, -5]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.038895% CI: [-44.4, -1.2]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.996295% CI: [-21.2, 21.1]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.083995% CI: [-42.3, 2.7]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.521695% CI: [-28.3, 14.4]Mixed Models Analysis

Comparison: Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).p-value: 0.053495% CI: [-42.9, 0.3]Mixed Models Analysis

Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6

Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6

Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores

Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline

Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline

Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline

Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week

Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline

Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline

Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline

Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline

Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline

Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)

Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)

Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6

Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline

Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline