A 17-Week Trial To Assess Pregabalin For The Treatment Of... | NCT00407745

A 17-Week Trial To Assess Pregabalin For The Treatment Of... | NCT00407745 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
matched placebo	Placebo Comparator		Drug: placebo
pregabalin	Experimental	flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period	Drug: pregabalin

Name	Type	Description	Arm Group Labels	Other Names
placebo	Drug	Placebo	matched placebo
pregabalin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration Adjusted Average Change (DAAC) of Mean Pain Score	DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.	Baseline, Week 16

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Weekly Mean Pain Score	Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).	Baseline, Week 16
Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline

Other Outcomes

Measure	Description	Time Frame
Change From Baseline in Weekly Mean Sleep Interference Score by Week	Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).	Baseline, Week 1 through 16

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Phoenix	Arizona	85016	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28072797	Derived	Schug SA, Parsons B, Almas M, Whalen E. Effect of Concomitant Pain Medications on Response to Pregabalin in Patients with Postherpetic Neuralgia or Spinal Cord Injury-Related Neuropathic Pain. Pain Physician. 2017 Jan-Feb;20(1):E53-E63.
27611736	Derived	Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Lack of Efficacy		FG0001 subjects FG0012 subjects
Withdrawal by Subject		FG0003 subjects FG0013 subjects
Protocol Violation		FG0005 subjects FG0013 subjects
Adverse Event		FG0008 subjects FG0018 subjects
Other		FG0002 subjects FG0010 subjects
Randomized, unknown if treated		FG0000 subjects FG0011 subjects

Arm/Group Information

ID	Title	Description
BG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
BG001	Placebo	Placebo matching study treatment.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

1 participant was randomized to placebo, but the actual drug taken was pregabalin. This subject was included in the placebo group for all baseline measures.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00046.1± 12.7 BG00145.6± 13.8 BG00245.9± 13.3

Age, Customized

Number

participants

Title

Denominators

Categories

Between 18 and 44 years

Title	Measurements
	BG00052 BG00153 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00027 BG00116 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Duration Adjusted Average Change (DAAC) of Mean Pain Score

DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.

mITT: all randomized participants who received at least one dose of study medication except the 8 participants who were randomized before protocol amendment 2.

Posted

Least Squares Mean

Standard Error

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Units	Counts
Participants	OG000105 OG001106

Title

Denominators

Categories

Title	Measurements
	OG000-1.66± 0.157 OG001-1.07± 0.149

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean DAAC for the pregabalin group is equal to the mean DAAC for the placebo group; Alternative hypothesis - the mean DAAC for the placebo group differs from the mean DAAC for the pregabalin group. ANCOVA model included baseline severity of pain and Baseline Pain Catastrophizing Scale (PCS) Total Score as covariates and pooled center and treatment as fixed (class) cofactors.	ANCOVA		0.0032	Significance was declared if the 2-tailed test for the difference between treatment groups was significant at the 0.05 level.	LS Mean Difference	-0.59	Standard Error of the Mean	0.198	2-Sided	95	-0.98	-0.20

Secondary

Change From Baseline in Weekly Mean Pain Score

Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).

mITT; modified baseline observation carried forward (mBOCF) imputation: mBOCF mean pain score was defined as the baseline mean pain score for participants who discontinued double-blind treatment due to adverse event or who had no postbaseline observations and as the last observation carried forward (LOCF) mean pain score for all other participants.

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Secondary

Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline

mITT; LOCF: LOCF Endpoint corresponded to the last 7 days of diary data up to and including Week 16 and applied if the Week 16 assessment was missing; (N) = number of participants that can be analyzed for the endpoint.

Posted

Number

participants

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Secondary

Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)

The PGIC is a participant-rated instrument measuring change in the participant's overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.

mITT; LOCF; (N) = number of participants with data available for analysis

Posted

Number

participants

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Units	Counts

Secondary

Change From Baseline in Weekly Mean Sleep Interference Score

Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Units	Counts
Participants

Secondary

Change From Baseline in Weekly Mean Pain Score by Week

ITT population: defined as all randomized participants who took at least one dose of study medication. (This population included the 8 participants who were randomized before the protocol amendment 2). (n) = number of participants with data for analysis.

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 1 through16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Secondary

Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline

mITT; LOCF; (N) = number of participants with data available for analysis

Posted

Number

participants

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Units	Counts

Other Pre-specified

Change From Baseline in Weekly Mean Sleep Interference Score by Week

Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).

ITT; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 1 through 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Units	Counts

Secondary

Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score

The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from "does not interfere" (0) to "completely interferes" (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale.

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Secondary

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia

Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Units	Counts

Secondary

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia

Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Units	Counts

Secondary

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia

Participant rated pain scale. The pain produced by the applied stimulus (Punctata hyperalgesia - pinprick) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Units	Counts

Secondary

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli

Participant rated pain scale. The pain produced by the applied stimulus (Temporal summation to tactile stimuli - repeated touching/tapping) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Units	Counts

Secondary

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia

Participant rated pain scale. The pain produced by the applied stimulus (Cold allodynia - touch with cool metal rod 13-17 degrees celsius was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Units	Counts

Secondary

Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales

Participant rated pain scale. The pain produced by the applied stimulus (Cold hyperalgesia - touch with cold metal rod 4 degrees celsius) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Units	Counts

Secondary

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score

Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo

Secondary

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain

mITT; LOCF;(n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo

Secondary

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo

Secondary

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Secondary

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Secondary

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo

Secondary

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo

Secondary

Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)

NPSI - Temporal item which assesses the duration (number of hours during the last 24 hours) of spontaneous ongoing pain. Improved duration would be a decrease in the number of hours of spontaneous ongoing pain during the last 24 hours compared to baseline.

MITT; LOCF; (N) = number of participants with data available for analysis

Posted

Number

participants

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Units	Counts

Secondary

Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)

NPSI - Temporal item which assesses the paroxysmal pain (number of pain attacks during the last 24 hours). Improvement in the number of attacks would be a decrease in the number of paroxysms during the last 24 hours compared to baseline.

MITT; LOCF; (N) = number of participants with data available for analysis

Posted

Number

participants

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Units	Counts

Secondary

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index

Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo

Secondary

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo

Secondary

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo

Secondary

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo

Secondary

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo

Secondary

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo

Secondary

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo

Secondary

Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)

mITT; LOCF; (N) = number of participants with data available for analysis

Posted

Number

participants

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo

Secondary

Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety

HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Secondary

Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression

mITT; LOCF; (n) = number of participants with data available for analysis

Posted

Mean

Standard Deviation

score on scale

Baseline, Week 16

ID	Title	Description
OG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
OG001	Placebo	Placebo matching study treatment.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pregabalin	Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.			9	112	78	112
EG001	Placebo	Placebo matching study treatment.			10	107	56	107

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bradycardia	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected107 at risk
Prinzmetal angina	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected107 at risk
Ear haemorrhage	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected107 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected107 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected107 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected107 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected112 at risk EG0010 affected107 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected107 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected107 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected107 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected107 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected107 at risk
Blood amylase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected107 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected107 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected107 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected107 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected107 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected107 at risk
Dystonia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected107 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected107 at risk
Dysuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected107 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected107 at risk
Hypotension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected107 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vision blurred	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected112 at risk EG0010 affected107 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected112 at risk EG0016 affected107 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected112 at risk EG0015 affected107 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected112 at risk EG0013 affected107 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected112 at risk EG0013 affected107 at risk
Fatigue	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00010 affected112 at risk EG0013 affected107 at risk
Oedema	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected112 at risk EG0012 affected107 at risk
Oedema peripheral	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00015 affected112 at risk EG0015 affected107 at risk
Pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected112 at risk EG0012 affected107 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG00013 affected112 at risk EG0018 affected107 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG00012 affected112 at risk EG00117 affected107 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00022 affected112 at risk EG0016 affected107 at risk
Headache	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected112 at risk EG0015 affected107 at risk
Somnolence	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00037 affected112 at risk EG00114 affected107 at risk
Insomnia	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected112 at risk EG0014 affected107 at risk

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D020196	Trauma, Nervous System
D014947	Wounds and Injuries

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included baseline severity (pain) and baseline PCS as covariates and effects for treatment and pooled center as fixed (class) cofactors.	0.0066	Serial gate-keeping multiple testing procedure was used. If primary comparison for DAAC was significant, then variables were assessed in a hierarchical manner. Significance was declared if unadjusted p-value was significant at 0.05 level (<=0.05).	LS Mean Difference	-0.70	Standard Error of the Mean	0.255	2-Sided	95	-1.20	-0.20					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group	Regression, Logistic	Logistic regression model used terms for baseline pain score and baseline PCS total score as covariate, and pooled center and treatment as cofactor.	0.0390	Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.	Odds Ratio (OR)	1.85			2-Sided	95	1.032	3.328					Superiority or Other (legacy)

Title

Denominators

Categories

1-Very much improved

Title	Measurements
	OG0007 OG0012

2-Much improved

Title	Measurements
	OG00033 OG00125

3-Minimally improved

Title	Measurements
	OG00038 OG00124

4-No change

Title	Measurements
	OG00019 OG00140

5-Minimally worse

Title	Measurements
	OG0002 OG0015

6-Much worse

Title	Measurements
	OG0000 OG0013

7-Very much worse

Title	Measurements
	OG0001 OG0010

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - The raw mean score for the pregabain group was equal to the raw mean score for the placebo group; Alternative hypothesis - The raw mean score for the pregabain group was not equal to the raw mean score for the placebo group.	Cochran-Mantel-Haenszel	Modified ridit transformation with the Cochran-Mantel- Haenszel test was used with adjusting for pooled center.	0.0006	Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.						95							Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included baseline sleep interference score as a covariate and pooled center and treatment as fixed (class) cofactors.	<0.0001	Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.	LS Mean Difference	-1.08	Standard Error of the Mean	0.265	2-Sided	95	-1.60	-0.56					Superiority or Other (legacy)

Title

Denominators

Categories

Baseline (n = 111, 108)

Title	Measurements
	OG0006.44± 1.44 OG0016.51± 1.40

Change at Week 1 (n = 111, 107)

Title	Measurements
	OG000-0.85± 1.04 OG001-0.38± 0.89

Change at Week 2 (n = 110, 105)

Title	Measurements
	OG000-1.26± 1.21 OG001-0.62± 1.30

Change at Week 3 (n = 107, 105)

Title	Measurements
	OG000-1.35± 1.35 OG001-0.86± 1.35

Change at Week 4 (n = 107, 103)

Title	Measurements
	OG000-1.64± 1.61 OG001-1.03± 1.53

Change at Week 5 (n = 105, 101)

Title	Measurements
	OG000-1.87± 1.73 OG001-1.07± 1.50

Change at Week 6 (n = 105, 99)

Title	Measurements
	OG000-1.89± 1.90 OG001-1.22± 1.72

Change at Week 7 (n = 103, 98)

Title	Measurements
	OG000-2.02± 1.86 OG001-1.34± 1.75

Change at Week 8 (n = 101, 97)

Title	Measurements
	OG000-1.96± 1.82 OG001-1.32± 1.82

Change at Week 9 (n = 98, 97)

Title	Measurements
	OG000-1.99± 1.81 OG001-1.37± 1.75

Change at Week 10 (n = 97, 91)

Title	Measurements
	OG000-2.03± 1.75 OG001-1.32± 1.81

Change at Week 11 (n = 96, 90)

Title	Measurements
	OG000-2.04± 1.82 OG001-1.43± 1.84

Change at Week 12 (n = 96, 91)

Title	Measurements
	OG000-1.90± 1.83 OG001-1.44± 1.93

Change at Week 13 (n = 93, 91)

Title	Measurements
	OG000-2.02± 1.76 OG001-1.39± 1.92

Change at Week 14 (n = 93, 92)

Title	Measurements
	OG000-2.00± 1.76 OG001-1.34± 1.89

Change at Week 15 (n = 93, 92)

Title	Measurements
	OG000-2.09± 1.80 OG001-1.41± 1.85

Change at Week 16 (n = 89, 90)

Title	Measurements
	OG000-2.17± 1.78 OG001-1.36± 1.87

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 1 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0295	Significance was declared if p-value <=0.05	LS Mean Difference	-0.49	Standard Error of the Mean	0.23	2-Sided	95	-0.94	-0.05	Superiority or Other (legacy)
OG000 OG001	Week 2 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0033	Significance was declared if p-value <=0.05	LS Mean Difference	-0.67	Standard Error of the Mean	0.23	2-Sided	95	-1.11	-0.22	Superiority or Other (legacy)
OG000 OG001	Week 3 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0185	Significance was declared if p-value <=0.05	LS Mean Difference	-0.54	Standard Error of the Mean	0.23	2-Sided	95	-0.98	-0.09	Superiority or Other (legacy)
OG000 OG001	Week 4 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0040	Significance was declared if p-value <=0.05	LS Mean Difference	-0.66	Standard Error of the Mean	0.23	2-Sided	95	-1.10	-0.21	Superiority or Other (legacy)
OG000 OG001	Week 5 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0004	Significance was declared if p-value <=0.05	LS Mean Difference	-0.81	Standard Error of the Mean	0.23	2-Sided	95	-1.26	-0.36	Superiority or Other (legacy)
OG000 OG001	Week 6 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0018	Significance was declared if p-value <=0.05	LS Mean Difference	-0.72	Standard Error of the Mean	0.23	2-Sided	95	-1.17	-0.27	Superiority or Other (legacy)
OG000 OG001	Week 7 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0027	Significance was declared if p-value <=0.05	LS Mean Difference	-0.69	Standard Error of the Mean	0.23	2-Sided	95	-1.14	-0.24	Superiority or Other (legacy)
OG000 OG001	Week 8 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0041	Significance was declared if p-value <=0.05	LS Mean Difference	-0.66	Standard Error of the Mean	0.23	2-Sided	95	-1.11	-0.21	Superiority or Other (legacy)
OG000 OG001	Week 9 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0058	Significance was declared if p-value <=0.05	LS Mean Difference	-0.64	Standard Error of the Mean	0.23	2-Sided	95	-1.09	-0.18	Superiority or Other (legacy)
OG000 OG001	Week 10 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0031	Significance was declared if p-value <=0.05	LS Mean Difference	-0.69	Standard Error of the Mean	0.23	2-Sided	95	-1.14	-0.23	Superiority or Other (legacy)
OG000 OG001	Week 11 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0076	Significance was declared if p-value <=0.05	LS Mean Difference	-0.62	Standard Error of the Mean	0.23	2-Sided	95	-1.08	-0.17	Superiority or Other (legacy)
OG000 OG001	Week 12 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0328	Significance was declared if p-value <=0.05	LS Mean Difference	-0.50	Standard Error of the Mean	0.23	2-Sided	95	-0.95	-0.04	Superiority or Other (legacy)
OG000 OG001	Week 13 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0150	Significance was declared if p-value <=0.05	LS Mean Difference	-0.57	Standard Error of the Mean	0.23	2-Sided	95	-1.02	-0.11	Superiority or Other (legacy)
OG000 OG001	Week 14 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0048	Significance was declared if p-value <=0.05	LS Mean Difference	-0.66	Standard Error of the Mean	0.23	2-Sided	95	-1.11	-0.20	Superiority or Other (legacy)
OG000 OG001	Week 15 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0030	Significance was declared if p-value <=0.05	LS Mean Difference	-0.69	Standard Error of the Mean	0.23	2-Sided	95	-1.15	-0.24	Superiority or Other (legacy)
OG000 OG001	Week 16 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0011	Significance was declared if p-value <=0.05	LS Mean Difference	-0.76	Standard Error of the Mean	0.23	2-Sided	95	-1.22	-0.30	Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group.	Regression, Logistic	Logistic regression used terms for treatment, baseline pain score as covariate, baseline PCS total score, and pooled center as cofactor.	0.0256	Significance was declared if p-value <=0.05	Odds Ratio (OR)	2.24			2-Sided	95	1.103	4.546					Superiority or Other (legacy)

Title

Denominators

Categories

Baseline (n = 111, 107)

Title	Measurements
	OG0004.86± 2.46 OG0015.18± 2.23

Change at Week 1 (n = 111, 106)

Title	Measurements
	OG000-0.96± 1.45 OG001-0.26± 0.85

Change at Week 2 (n = 110, 104)

Title	Measurements
	OG000-1.29± 1.63 OG001-0.49± 1.17

Change at Week 3 (n = 107, 104)

Title	Measurements
	OG000-1.36± 1.68 OG001-0.61± 1.27

Change at Week 4 (n = 107, 102)

Title	Measurements
	OG000-1.59± 1.85 OG001-0.90± 1.45

Change at Week 5 (n = 105, 100)

Title	Measurements
	OG000-1.81± 2.05 OG001-0.91± 1.38

Change at Week 6 (n = 105, 98)

Title	Measurements
	OG000-1.86± 2.14 OG001-0.99± 1.48

Change at Week 7 (n = 103, 97)

Title	Measurements
	OG000-1.98± 2.19 OG001-1.10± 1.50

Change at Week 8 (n = 101, 96)

Title	Measurements
	OG000-1.97± 2.18 OG001-1.11± 1.59

Change at Week 9 (n = 98, 96)

Title	Measurements
	OG000-2.03± 2.13 OG001-1.11± 1.72

Change at Week 10 (n = 97, 90)

Title	Measurements
	OG000-2.18± 2.06 OG001-1.12± 1.74

Change at Week 11 (n = 96, 89)

Title	Measurements
	OG000-2.08± 2.15 OG001-1.20± 1.85

Change at Week 12 (n = 96, 90)

Title	Measurements
	OG000-2.07± 2.21 OG001-1.20± 1.75

Change at Week 13 (n = 93, 90)

Title	Measurements
	OG000-2.08± 2.21 OG001-1.19± 1.82

Change at Week 14 (n = 93, 91)

Title	Measurements
	OG000-2.09± 2.13 OG001-1.18± 1.83

Change at Week 15 (n = 93, 91)

Title	Measurements
	OG000-2.15± 2.10 OG001-1.11± 1.83

Change at Week 16 (n = 89, 89)

Title	Measurements
	OG000-2.25± 2.24 OG001-1.17± 1.82

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 1. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0004	Significance was declared if p-value <=0.05	LS mean difference	-0.79	Standard Error of the Mean	0.22	2-Sided	95	-1.23	-0.35	Superiority or Other (legacy)
OG000 OG001	Week2 A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	<0.0001	Significance was declared if p-value <=0.05	LS mean difference	-0.87	Standard Error of the Mean	0.22	2-Sided	95	-1.31	-0.43	Superiority or Other (legacy)
OG000 OG001	Week 3. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0004	Significance was declared if p-value <=0.05	LS mean difference	-0.80	Standard Error of the Mean	0.22	2-Sided	95	-1.24	-0.36	Superiority or Other (legacy)
OG000 OG001	Week 4. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	0.0008	Significance was declared if p-value <=0.05	LS mean difference	-0.76	Standard Error of the Mean	0.23	2-Sided	95	-1.20	-0.32	Superiority or Other (legacy)
OG000 OG001	Week 5. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	<0.0001	Significance was declared if p-value <=0.05	LS mean difference	-0.94	Standard Error of the Mean	0.23	2-Sided	95	-1.38	-0.49	Superiority or Other (legacy)
OG000 OG001	Week 6. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	<0.0001	Significance was declared if p-value <=0.05	LS mean difference	-0.93	Standard Error of the Mean	0.23	2-Sided	95	-1.37	-0.48	Superiority or Other (legacy)
OG000 OG001	Week 7. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	<0.0001	Significance was declared if p-value <=0.05	LS mean difference	-0.91	Standard Error of the Mean	0.23	2-Sided	95	-1.35	-0.47	Superiority or Other (legacy)
OG000 OG001	Week 8. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	<0.0001	Significance was declared if p-value <=0.05	LS mean difference	-0.90	Standard Error of the Mean	0.23	2-Sided	95	-1.35	-0.46	Superiority or Other (legacy)
OG000 OG001	Week 9. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	<0.0001	Significance was declared if p-value <=0.05	LS mean difference	-0.94	Standard Error of the Mean	0.23	2-Sided	95	-1.39	-0.50	Superiority or Other (legacy)
OG000 OG001	Week 10. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	<0.0001	Significance was declared if p-value <=0.05	LS mean difference	-1.08	Standard Error of the Mean	0.23	2-Sided	95	-1.53	-0.63	Superiority or Other (legacy)
OG000 OG001	Week 11. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	<0.0001	Significance was declared if p-value <=0.05	LS mean difference	-0.94	Standard Error of the Mean	0.23	2-Sided	95	-1.39	-0.49	Superiority or Other (legacy)
OG000 OG001	Week 12. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	<0.0001	Significance was declared if p-value <=0.05	LS mean difference	-0.92	Standard Error of the Mean	0.23	2-Sided	95	-1.37	-0.47	Superiority or Other (legacy)
OG000 OG001	Week 13. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	<0.0001	Significance was declared if p-value <=0.05	LS mean difference	-0.92	Standard Error of the Mean	0.23	2-Sided	95	-1.38	-0.47	Superiority or Other (legacy)
OG000 OG001	Week 14. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	<0.0001	Significance was declared if p-value <=0.05	LS mean difference	-0.96	Standard Error of the Mean	0.23	2-Sided	95	-1.41	-0.51	Superiority or Other (legacy)
OG000 OG001	Week 15. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	<0.0001	Significance was declared if p-value <=0.05	LS mean difference	-1.08	Standard Error of the Mean	0.23	2-Sided	95	-1.53	-0.63	Superiority or Other (legacy)
OG000 OG001	Week 16. A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used. Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.	Mixed Models Analysis	<0.0001	Significance was declared if p-value <=0.05	LS mean difference	-1.06	Standard Error of the Mean	0.23	2-Sided	95	-1.51	-0.61	Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline mBPI-10 Total Score as a covariate and pooled center and treatment as fixed (class) cofactors.	0.0438	Significance was declared if p-value <=0.05	LS Mean Difference	-0.55	Standard Error of the Mean	0.269	2-Sided	95	-1.08	-0.02					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	At/above level: within 2 dermatomes above or below the neurological level of injury (NLI). Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.	0.7103	Significance was declared if p-value <=0.05	LS mean difference	-0.17	Standard Error of the Mean	0.448	2-Sided	95	-1.06	0.72					Superiority or Other (legacy)
OG000 OG001	Below level: more than 2 dermatomes below the NLI. Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.	0.0747	Significance was declared if p-value <=0.05	LS mean difference	-0.61	Standard Error of the Mean	0.340	2-Sided	95	-1.28	0.06					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	At/Above level Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.	0.5689	Significance was declared if p-value <=0.05	LS mean difference	-0.22	Standard Error of the Mean	0.379	2-Sided	95	-0.97	0.54					Superiority or Other (legacy)
OG000 OG001	Below level Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.	0.4764	Significance was declared if p-value <=0.05	LS mean difference	-0.23	Standard Error of the Mean	0.322	2-Sided	95	-0.87	0.41					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	At/Above level Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.	0.3362	Significance was declared if p-value <=0.05	LS mean difference	-0.46	Standard Error of the Mean	0.474	2-Sided	95	-1.40	0.48					Superiority or Other (legacy)
OG000 OG001	Below level Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.	0.3113	Significance was declared if p-value <=0.05	LS mean difference	-0.33	Standard Error of the Mean	0.321	2-Sided	95	-0.96	0.31					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	At/Above level Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.	0.2721	Significance was declared if p-value <=0.05	LS mean difference	-0.60	Standard Error of the Mean	0.539	2-Sided	95	-1.67	0.48					Superiority or Other (legacy)
OG000 OG001	Below level Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.	0.4906	Significance was declared if p-value <=0.05	LS mean difference	0.23	Standard Error of the Mean	0.337	2-Sided	95	-0.43	0.90					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	At/Above level Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.	0.3123	Significance was declared if p-value <=0.05	LS mean difference	-0.48	Standard Error of the Mean	0.472	2-Sided	95	-1.42	0.46					Superiority or Other (legacy)
OG000 OG001	Below level Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.	0.1360	Significance was declared if p-value <=0.05	LS mean difference	-0.55	Standard Error of the Mean	0.368	2-Sided	95	-1.28	0.18					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	At/Above level Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.	0.4257	Significance was declared if p-value <=0.05	LS mean difference	-0.44	Standard Error of the Mean	0.549	2-Sided	95	-1.53	0.65					Superiority or Other (legacy)
OG000 OG001	Below level Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.	0.2005	Significance was declared if p-value <=0.05	LS mean difference	-0.53	Standard Error of the Mean	0.412	2-Sided	95	-1.34	0.28					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - 12 Items Total Intensity Score as covariate and pooled center and treatment as fixed (class) cofactors.	0.1377	Significance was declared if p-value <=0.05	LS mean difference	-0.04	Standard Error of the Mean	0.025	2-Sided	95	-0.09	0.01					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Burning Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.	0.3312	Significance was declared if p-value <=0.05	LS mean difference	-0.04	Standard Error of the Mean	0.038	2-Sided	95	-0.11	0.04					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Pressing Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.	0.0440	Significance was declared if p-value <=0.05	LS mean difference	-0.07	Standard Error of the Mean	0.033	2-Sided	95	-0.13	0.00					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Paroxysmal Pain as covariate and pooled center and treatment as fixed (class) cofactors.	0.1370	Significance was declared if p-value <=0.05	LS mean difference	-0.05	Standard Error of the Mean	0.033	2-Sided	95	-0.12	0.02					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Evoked pain as covariate and pooled center and treatment as fixed (class) cofactors.	0.8911	Significance was declared if p-value <=0.05	LS mean difference	0.00	Standard Error of the Mean	0.028	2-Sided	95	-0.06	0.05					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Paresthesia/Dysesthesia as covariate and pooled center and treatment as fixed (class) cofactors.	0.3731	Significance was declared if p-value <=0.05	LS mean difference	-0.03	Standard Error of the Mean	0.034	2-Sided	95	-0.10	0.04					Superiority or Other (legacy)

Title

Denominators

Categories

1- Burning pain (n = 100, 99)

Title	Measurements
	OG000-1.39± 3.420 OG001-1.00± 2.825

2- Squeezing pain (n = 100, 99)

Title	Measurements
	OG000-1.04± 3.181 OG001-0.41± 3.110

3- Pain like pressure (n = 100, 99)

Title	Measurements
	OG000-0.73± 3.429 OG001-0.20± 3.326

5- Electric shocks (n = 100, 99)

Title	Measurements
	OG000-1.77± 3.426 OG001-0.68± 3.664

6- Stabbing pain (n = 100, 99)

Title	Measurements
	OG000-1.13± 3.541 OG001-0.52± 2.804

8- By light touching (n = 100, 99)

Title	Measurements
	OG000-0.78± 3.080 OG001-0.94± 2.683

9- By pressure (n = 100, 99)

Title	Measurements
	OG000-1.22± 2.784 OG001-1.10± 2.675

10- By something cold (n = 100, 99)

Title	Measurements
	OG000-0.89± 3.372 OG001-0.52± 2.459

11- Pins and needles (n = 99, 99)

Title	Measurements
	OG000-1.01± 3.125 OG001-0.62± 3.269

12- Tingling (n = 99, 99)

Title	Measurements
	OG000-0.99± 3.559 OG001-0.83± 3.034

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Item 1 - Burning pain Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.	0.3312	Significance was declared if p-value <=0.05	LS mean difference	-0.37	Standard Error of the Mean	0.383	2-Sided	95	-1.13	0.38	Superiority or Other (legacy)
OG000 OG001	Item 2 - Squeezing pain Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.	0.0976	Significance was declared if p-value <=0.05	LS mean difference	-0.63	Standard Error of the Mean	0.377	2-Sided	95	-1.37	0.12	Superiority or Other (legacy)
OG000 OG001	Item 3 - Pain like pressure Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.	0.0538	Significance was declared if p-value <=0.05	LS mean difference	-0.76	Standard Error of the Mean	0.393	2-Sided	95	-1.54	0.01	Superiority or Other (legacy)
OG000 OG001	Item 5 - Electric shocks Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.	0.3239	Significance was declared if p-value <=0.05	LS mean difference	-0.38	Standard Error of the Mean	0.389	2-Sided	95	-1.15	0.38	Superiority or Other (legacy)
OG000 OG001	Item 6 - Stabbing pain Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.	0.1912	Significance was declared if p-value <=0.05	LS mean difference	-0.49	Standard Error of the Mean	0.376	2-Sided	95	-1.23	0.25	Superiority or Other (legacy)
OG000 OG001	Item 8 - By light touching Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.	0.6720	Significance was declared if p-value <=0.05	LS mean difference	0.15	Standard Error of the Mean	0.353	2-Sided	95	-0.55	0.85	Superiority or Other (legacy)
OG000 OG001	Item 9 - By pressure Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.	0.7821	Significance was declared if p-value <=0.05	LS mean difference	-0.09	Standard Error of the Mean	0.330	2-Sided	95	-0.74	0.56	Superiority or Other (legacy)
OG000 OG001	Item 10 - By something cold Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.	0.6851	Significance was declared if p-value <=0.05	LS mean difference	-0.14	Standard Error of the Mean	0.352	2-Sided	95	-0.84	0.55	Superiority or Other (legacy)
OG000 OG001	Item 11 - Pins and needles Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.	0.3610	Significance was declared if p-value <=0.05	LS mean difference	-0.35	Standard Error of the Mean	0.387	2-Sided	95	-1.12	0.41	Superiority or Other (legacy)
OG000 OG001	Item 12 - Tingling Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.	0.4915	Significance was declared if p-value <=0.05	LS mean difference	-0.28	Standard Error of the Mean	0.402	2-Sided	95	-1.07	0.52	Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.	Cochran-Mantel-Haenszel		0.0536	p-values are adjusted for baseline score. Significance was declared if p-value <=0.05.						95							Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.	Cochran-Mantel-Haenszel		0.3107	p-values are adjusted for baseline score. Significance was declared if p-value <=0.05.						95							Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline MOS 9-item Sleep Problems Index as a covariate and pooled center and treatment as fixed (class) cofactors.	0.0262	Significance was declared if p-value <=0.05	LS mean difference	-4.89	Standard Error of the Mean	2.182	2-Sided	95	-9.19	-0.59					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline MOS - Sleep disturbance as a covariate and pooled center and treatment as fixed (class) cofactors.	0.0041	Significance was declared if p-value <=0.05	LS mean difference	-8.67	Standard Error of the Mean	2.985	2-Sided	95	-14.55	-2.78					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline MOS - Sleep Adequacy as a covariate and pooled center and treatment as fixed (class) cofactors.	0.0998	Significance was declared if p-value <=0.05	LS mean difference	5.78	Standard Error of the Mean	3.492	2-Sided	95	-1.11	12.66					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline MOS - Snoring as a covariate and pooled center and treatment as fixed (class) cofactors.	0.1048	Significance was declared if p-value <=0.05	LS mean difference	5.70	Standard Error of the Mean	3.501	2-Sided	95	-1.20	12.61					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included baseline MOS - Awaken Short of Breath or with headache as covariate and pooled center and treatment as fixed (class) cofactors.	0.0347	Significance was declared if p-value <=0.05	LS mean difference	-5.14	Standard Error of the Mean	2.417	2-Sided	95	-9.91	-0.37					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline MOS - Sleep Quantity as a covariate and pooled center and treatment as fixed (class) cofactors.	0.0436	Significance was declared if p-value <=0.05	LS mean difference	0.38	Standard Error of the Mean	0.189	2-Sided	95	0.01	0.76					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline MOS - Somnolence as a covariate and pooled center and treatment as fixed (class) cofactors.	0.2761	Significance was declared if p-value <=0.05	LS mean difference	3.02	Standard Error of the Mean	2.770	2-Sided	95	-2.44	8.49					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - The rate of subjects with optimal sleep for the pregabain group was equal to the rate of subjects with optimal sleep for the placebo group; Alternative hypothesis - The rate of subjects with optimal sleep for the pregabain group was not equal to the rate of subjects with optimal sleep for the placebo group.	Regression, Logistic	Logistic Regression Model included Pooled Center and Treatment as the categorical factors, and Optimal Sleep Score at Baseline as the covariate.	0.0024	Significance was declared if p-value <=0.05	Odds Ratio (OR)	2.81			2-Sided	95	1.443	5.491					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline HADS - Anxiety as a covariate and pooled center and treatment as fixed (class) cofactors.	0.1164	Significance was declared if p-value <=0.05	LS mean difference	-0.68	Standard Error of the Mean	0.433	2-Sided	95	-1.54	0.17					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.	ANCOVA	ANCOVA model included terms of baseline HADS - Depression as a covariate and pooled center and treatment as fixed (class) cofactors.	0.0279	Significance was declared if p-value <=0.05	LS mean difference	-0.99	Standard Error of the Mean	0.447	2-Sided	95	-1.87	-0.11					Superiority or Other (legacy)