Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy

• ClinicalTrials.gov Identifier: NCT00232141
• Recruitment Status: Completed
• First Posted: October 4, 2005
• Results First Posted: August 11, 2009
• Last Update Posted: February 9, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: HIV Infections; Peripheral Neuropathy
• Interventions: Drug: pregabalin; Drug: Placebo
• Enrollment: 302

Participant Flow

Recruitment Details	43 centers in the United States; Study Initiation and Completion Dates: 6 October 2005 to 27 November 2007
Pre-assignment Details	A total of 472 subjects were screened for the study, and 302 subjects were randomized to study treatment.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Period Title: Overall Study
Started	151	151
Completed	120	125
Not Completed	31	26
Reason Not Completed
Adverse Event	9	4
Lack of Efficacy	0	3
Lost to Follow-up	9	6
Other	8	10
Withdrawal by Subject	5	3

Baseline Characteristics

Arm/Group Title		Pregabalin	Placebo	Total
Arm/Group Description		Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.	Total of all reporting groups
Overall Number of Baseline Participants		151	151	302
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	151 participants	151 participants	302 participants
		48.2 (8.1)	46.8 (7.5)	47.5 (7.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	151 participants	151 participants	302 participants
	Female	26 17.2%	31 20.5%	57 18.9%
	Male	125 82.8%	120 79.5%	245 81.1%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline
Description	Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

ITT population (ie, full analysis set)=all randomized participants who took at least 1 dose & had at least 1 post-randomization efficacy assessment. The endpoint-LOCF mean value was computed from last 7 diary entries (Day 2 up to and including the day after the last dose w/n Dose-Adjustment or Maintenance phase (up to Day 99).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	141	140
Least Squares Mean (Standard Error); Unit of Measure: score on scale
	-2.88 (0.21)	-2.63 (0.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Primary hypotheses : null (H0): µA=µP vs alternative (HA): µA≠µP (µA and µP represent true means for primary endpoint in active treatment & placebo groups respectively). Assumptions in power calculation: 2-sided test with type I error at α =0.05, type II error at β =0.10, & a common s.d of 2.2 for primary endpoint (based on previous clinical trial data). With n=150 subjects/ group (300 subjects overall) at least 90% power to detect a treatment difference of at least 1.1 in primary endpoint
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3914
	Comments	The analysis procedures planned will control the Type I error for the primary analysis. No multiplicity adjustment is needed for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.25
	Confidence Interval	95%; -0.83 to 0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices
Description	Change from baseline in MOS-Sleep subscales & Sleep Problem Indices. Twelve item subject-rated questionnaire assessing sleep constructs. Scores range from 0 - 100 and higher scores reflect more impairment. Subscales "sleep adequacy", "quantity of sleep" and "optimal sleep" low scores reflect impairment.
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	127	128
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Disturbances (n=127,125)	-13.17 (1.82)	-14.71 (1.83)
Quantity (n=123,122)	0.39 (0.18)	0.65 (0.19)
Adequacy (n=126,128)	10.04 (2.12)	10.09 (2.11)
Awaken Short of Breath or w/Headache (n=125,128)	-6.52 (1.82)	-7.93 (1.80)
Somnolence (n=125,128)	-5.61 (1.81)	-7.01 (1.79)
Snoring (n=122,126)	4.34 (2.34)	-5.00 (2.29)
Sleep problems Index I (n=122,127)	-10.11 (1.44)	-11.18 (1.41)
Sleep problems Index II (n=122,125)	-10.16 (1.37)	-11.59 (1.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Disturbance.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5425
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.54
	Confidence Interval	95%; -3.44 to 6.52
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.53
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Quantity
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3184
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.25
	Confidence Interval	95%; -0.75 to 0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Adequacy
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9886
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	95%; -5.81 to 5.72
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.92
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Awaken Short of Breath or with Headache
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5742
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.41
	Confidence Interval	95%; -3.53 to 6.35
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.51
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Somnolence
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5775
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.40
	Confidence Interval	95%; -3.54 to 6.33
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.50
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Snoring
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0040
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.34
	Confidence Interval	95%; 3.02 to 15.66
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.21
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Sleep Problems Index I
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5882
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.07
	Confidence Interval	95%; -2.83 to 4.97
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.98
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Sleep Problems Index II
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4516
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.42
	Confidence Interval	95%; -2.30 to 5.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.89
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales
Description	Change from Baseline in scale at endpoint: normal (score 0) to severe (score 21).
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	128	128
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Anxiety	-1.33 (0.28)	-1.59 (0.28)
Depression	-1.10 (0.26)	-1.52 (0.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Anxiety
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5105
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.26
	Confidence Interval	95%; -0.51 to 1.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.39
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Depression
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2513
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.42
	Confidence Interval	95%; -0.30 to 1.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.37
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores
Description	Change from baseline to endpoint in the mBPI-sf to assess pain severity and pain interference with functional activities: 11-point scale ranging from "no pain" (0) to "pain as bad as you can imagine" (10)
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

ITT Population; n = number of participants with data for analysis reported (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	148	147
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Pain Severity Index (n=148,147)	-2.42 (0.19)	-2.56 (0.19)
Pain Interference Index (n=146,146)	-2.32 (0.18)	-2.39 (0.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Pain Severity Index
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5834
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.15
	Confidence Interval	95%; -0.38 to 0.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Pain Interference Index
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7783
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.07
	Confidence Interval	95%; -0.43 to 0.57
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Change From Baseline for NRS-Sleep Interference Scores
Description	11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain])
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	140	140
Least Squares Mean (Standard Error); Unit of Measure: score on scale
	-2.53 (0.20)	-2.34 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4776
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.19
	Confidence Interval	95%; -0.73 to 0.34
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Categorized Patient Global Impression of Change (PGIC)
Description	The PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). PGIC was evaluated using 3 categories of Improvement (Scores 1-3), No Change (Score 4), and Worsening (Scores 5-7).
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	149	150
Measure Type: Number; Unit of Measure: participants
Improved (scores 1-3)	106	84
No Change (score 4)	17	32
Worsened (scores 5-7)	5	10

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0077
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

7. Secondary Outcome

Title	Patient Global Impression of Change (PGIC) Rating
Description	PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).
Time Frame	Baseline, Week 14, Endpoint-LOCF

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	149	150
Measure Type: Number; Unit of Measure: participants
Very much improved (score 1)	27	27
Much improved (score 2)	41	38
Minimally improved (score 3)	38	19
No change (score 4)	17	32
Minimally worse (score 5)	2	5
Much worse (score 6)	3	5
Very much worse (score 7)	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3852
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

8. Secondary Outcome

Title	Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores
Description	Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. 10 pain descriptors questions answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). 2 items related to temporal pain assessed on 5-point scales. The NPSI derives 5 pain subscores & a total intensity score calculated from the 5 pain subscores
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	127	128
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Burning (n=127,126)	-0.19 (0.02)	-0.22 (0.02)
Pressing (n=125,126)	-0.17 (0.02)	-0.15 (0.02)
Paroxysmal (n=127,127)	-0.16 (0.02)	-0.17 (0.02)
Evoked (n=126,128)	-0.16 (0.02)	-0.15 (0.02)
Paresthesia/dysesthesia (n=126,128)	-0.19 (0.02)	-0.23 (0.02)
Total score (n=124,126)	-0.01 (0)	-0.01 (0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Burning
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3097
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	95%; -0.03 to 0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.03
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Pressing
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6147
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	95%; -0.07 to 0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.03
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Paroxysmal
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6838
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	95%; -0.05 to 0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.03
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Evoked
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6479
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01
	Confidence Interval	95%; -0.07 to 0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.03
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Paresthesia/dysesthesia
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1849
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.04
	Confidence Interval	95%; -0.02 to 0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.03
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Total Score
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5898
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0
	Confidence Interval	95%; 0 to 0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Change in Quantitative Assessment of Neuropathic Pain (QANeP)
Description	Change in a quantitative assessment of the participants' neuropathic pain were on an 11-point scale ranging from 0 (no pain) to 10 (most intense pain imaginable).
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	120	119
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Static mechanical allodynia (n=120,119)	-1.11 (0.21)	-1.22 (0.21)
Dynamic mechanical allodynia (n=120,119)	-0.99 (0.18)	-0.77 (0.18)
Punctate hyperalgesia testing area (n=118,119)	-0.78 (0.25)	-0.68 (0.26)
Temporal summation to tactile stimuli (n=120,118)	-1.21 (0.24)	-1.04 (0.24)
Cold allodynia testing area (n=120,117)	-1.19 (0.23)	-0.90 (0.24)
Cold hyperalgesia testing area (n=117,112)	-0.82 (0.27)	-0.93 (0.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Static mechanical allodynia
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6865
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.12
	Confidence Interval	95%; -0.45 to 0.68
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Dynamic mechanical allodynia
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3787
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.22
	Confidence Interval	95%; -0.71 to 0.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Punctate hyperalgesia testing area
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7704
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.10
	Confidence Interval	95%; -0.79 to 0.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.35
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Temporal summation to tactile stimuli
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6088
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.17
	Confidence Interval	95%; -0.82 to 0.48
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.33
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Cold allodynia testing area
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3767
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.29
	Confidence Interval	95%; -0.93 to 0.35
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.33
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Cold hyperalgesia testing area
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7689
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.11
	Confidence Interval	95%; -0.64 to 0.86
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.38
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Change in NRS-Sleep Interference Scores
Description	Change in mean Pain-related sleep interference was assessed on an 11-point scale from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Weekly mean score was the sum of the daily diary scores divided by the number of diary entries during that week.
Time Frame	Baseline, Weeks 1-14

Outcome Measure Data

Analysis Population Description

ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	135	133
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Week 1 (n=135, 133)	-1.04 (0.13)	-0.68 (0.13)
Week 2 (n=123,132)	-1.99 (0.17)	-1.36 (0.16)
Week 3 (n=117,121)	-2.26 (0.19)	-1.68 (0.19)
Week 4 (n=117,124)	-2.34 (0.20)	-2.01 (0.19)
Week 5 (n=115,121)	-2.57 (0.20)	-2.22 (0.19)
Week 6 (n=110,119)	-2.73 (0.20)	-2.18 (0.19)
Week 7 (n=110,111)	-2.89 (0.21)	-2.28 (0.21)
Week 8 (n=109,111)	-2.98 (0.21)	-2.29 (0.21)
Week 9 (n=105,111)	-2.73 (0.22)	-2.25 (0.21)
Week 10 (n=104,114)	-2.79 (0.22)	-2.32 (0.20)
Week 11 (n=100,106)	-2.76 (0.22)	-2.32 (0.21)
Week 12 (n=94,105)	-2.83 (0.24)	-2.29 (0.22)
Week 13 (n=94,105)	-2.95 (0.24)	-2.28 (0.22)
Week 14 (n=90,94)	-2.93 (0.25)	-2.30 (0.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 1
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0469
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.36
	Confidence Interval	95%; -0.71 to -0.00
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.18
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0067
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.63
	Confidence Interval	95%; -1.08 to -0.18
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 3
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0310
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.58
	Confidence Interval	95%; -1.10 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 4
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2088
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.34
	Confidence Interval	95%; -0.86 to 0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 5
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1849
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.35
	Confidence Interval	95%; -0.87 to 0.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 6
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0452
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.55
	Confidence Interval	95%; -1.09 to -0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 7
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0359
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.61
	Confidence Interval	95%; -1.18 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 8
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0184
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.69
	Confidence Interval	95%; -1.26 to -0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 9
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1043
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.48
	Confidence Interval	95%; -1.06 to 0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 10
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1053
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.47
	Confidence Interval	95%; -1.04 to 0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 11
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1440
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.44
	Confidence Interval	95%; -1.03 to 0.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 12
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0866
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.55
	Confidence Interval	95%; -1.17 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.32
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 13
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0359
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.67
	Confidence Interval	95%; -1.30 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.32
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 14
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0711
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.62
	Confidence Interval	95%; -1.30 to 0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.34
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Shift in Hospital Anxiety and Depression (HADS) Subscales
Description	Anxiety subscale analyzes generalized anxiety (anxious mood,restlessness, anxious thoughts, panic attacks). The depression subscale focuses on the state of lost interest and diminished pleasure response. A score of Normal = 0-7, Mild = 8-10, Moderate = 11-14, Severe = 15-21.
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	128	128
Measure Type: Number; Unit of Measure: participants
Anxiety-normal (baseline&endpoint)	47	55
Anxiety-normal (baseline)& mild (endpoint)	7	6
Anxiety-normal (baseline)& moderate(endpoint)	2	2
Anxiety-normal(baseline)&severe(endpoint)	0	0
Anxiety-mild(baseline)& normal(endpoint)	23	19
Anxiety-mild(baseline)& mild(endpoint)	7	6
Anxiety-mild(baseline)& moderate(endpoint)	2	6
Anxiety-mild(baseline)& severe(endpoint)	2	0
Anxiety-moderate(baseline)& normal(endpoint)	11	8
Anxiety-moderate(baseline)& mild(endpoint)	6	9
Anxiety-moderate(baseline)& moderate(endpoint)	8	5
Anxiety-moderate(baseline)& severe(endpoint)	3	1
Anxiety-severe(baseline)& normal(endpoint)	0	1
Anxiety-severe(baseline)& mild(endpoint)	1	2
Anxiety-severe(baseline)& moderate(endpoint)	7	6
Anxiety-severe(baseline)&severe(endpoint)	2	2
Depression-normal (baseline&endpoint)	75	69
Depression-normal (baseline)&mild (endpoint)	8	7
Depression-normal (baseline)&moderate (endpoint)	2	2
Depression-normal (baseline)&severe (endpoint)	1	0
Depression-mild (baseline)&normal(endpoint)	19	21
Depression-mild (baseline)&mild(endpoint)	5	5
Depression-mild (baseline)&moderate(endpoint)	3	2
Depression-mild (baseline)&severe(endpoint)	0	0
Depression-moderate (baseline)&normal(endpoint)	5	11
Depression-moderate (baseline)&mild(endpoint)	6	7
Depression-moderate (baseline)&moderate(endpoint)	2	2
Depression-moderate (baseline)&severe(endpoint)	1	1
Depression-severe (baseline)&normal(endpoint)	0	0
Depression-severe (baseline)&mild(endpoint)	0	0
Depression-severe (baseline)&moderate(endpoint)	0	0
Depression-severe (baseline)&severe(endpoint)	1	1

12. Secondary Outcome

Title	Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours)
Description	Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time Frame	Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF

Outcome Measure Data

Analysis Population Description

ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	148	147
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Week 1 (n=145,147)	-1.52 (0.17)	-1.09 (0.17)
Week 2 (n=139,143)	-2.18 (0.20)	-2.20 (0.20)
Week 6 (n=132,134)	-3.08 (0.21)	-2.95 (0.21)
Week 10 (n=126,128)	-3.02 (0.21)	-3.03 (0.21)
Week 14 (n=116,120)	-2.97 (0.24)	-3.01 (0.24)
Endpoint -LOCF (n=148,147)	-2.82 (0.22)	-2.88 (0.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 1
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0685
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.43
	Confidence Interval	95%; -0.89 to 0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9280
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	95%; -0.52 to 0.57
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 6
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6672
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.13
	Confidence Interval	95%; -0.71 to 0.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 10
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9731
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	95%; -0.57 to 0.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 14
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9045
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.04
	Confidence Interval	95%; -0.61 to 0.69
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.33
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Endpoint
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8298
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.07
	Confidence Interval	95%; -0.53 to 0.66
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours)
Description	Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time Frame	Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF

Outcome Measure Data

Analysis Population Description

ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	148	147
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Week 1 (n=145,147)	-0.84 (0.18)	-0.80 (0.17)
Week 2 (n=139,143)	-1.49 (0.19)	-1.44 (0.19)
Week 6 (n=132,134)	-2.37 (0.19)	-2.05 (0.18)
Week 10 (n=126,128)	-2.32 (0.20)	-2.13 (0.19)
Week 14 (n=116,120)	-2.27 (0.20)	-2.41 (0.20)
Endpoint (n=148,147)	-2.07 (0.19)	-2.20 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 1
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8605
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	95%; -0.52 to 0.44
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8348
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.06
	Confidence Interval	95%; -0.58 to 0.47
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 6
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2227
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.32
	Confidence Interval	95%; -0.83 to 0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 10
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4753
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.19
	Confidence Interval	95%; -0.73 to 0.34
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 14
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6017
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.14
	Confidence Interval	95%; -0.40 to 0.68
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Endpoint
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6158
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.13
	Confidence Interval	95%; -0.38 to 0.64
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments	[Not Specified]

14. Secondary Outcome

Title	Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours)
Description	Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time Frame	Baseline, Weeks 1,2,6,10,14 and Endpoint

Outcome Measure Data

Analysis Population Description

ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	148	147
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Week 1 (n=145,147)	-1.15 (0.16)	-0.90 (0.16)
Week 2 (n=139,143)	-1.79 (0.17)	-1.77 (0.17)
Week 6 (n=132,134)	-2.64 (0.20)	-2.55 (0.19)
Week 10 (n=126,128)	-2.86 (0.20)	-2.61 (0.19)
Week 14 (n=116,120)	-2.58 (0.22)	-2.71 (0.22)
Endpoint (n=148,147)	-2.37 (0.20)	-2.60 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 1
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2390
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.26
	Confidence Interval	95%; -0.69 to 0.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9444
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	95%; -0.49 to 0.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 6
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7386
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.09
	Confidence Interval	95%; -0.63 to 0.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 10
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3493
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.25
	Confidence Interval	95%; -0.79 to 0.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 14
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6596
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.13
	Confidence Interval	95%; -0.46 to 0.73
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Endpoint
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4075
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.23
	Confidence Interval	95%; -0.31 to 0.77
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

15. Secondary Outcome

Title	Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now)
Description	Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time Frame	Baseline, Weeks 1,2,6,10,14 and Endpoint

Outcome Measure Data

Analysis Population Description

ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	148	147
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Week 1 (n=144,147)	-1.56 (0.17)	-1.01 (0.17)
Week 2 (n=139,143)	-2.02 (0.19)	-1.98 (0.19)
Week 6 (n=132,134)	-2.66 (0.20)	-2.66 (0.20)
Week 10 (n=126,128)	-2.72 (0.20)	-2.57 (0.20)
Week 14 (n=116, 120)	-2.43 (0.23)	-2.72 (0.22)
Endpoint (n=148,147)	-2.26 (0.21)	-2.57 (0.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 1
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0202
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.55
	Confidence Interval	95%; -1.01 to -0.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8865
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	95%; -0.55 to 0.47
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 6
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9964
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	95%; -0.54 to 0.54
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 10
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5993
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.15
	Confidence Interval	95%; -0.70 to 0.41
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 14
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3553
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.29
	Confidence Interval	95%; -0.33 to 0.90
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.31
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Endpoint
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2771
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.31
	Confidence Interval	95%; -0.25 to 0.88
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity)
Description	Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time Frame	Baseline, Weeks 1,2,6,10,14 and Endpoint

Outcome Measure Data

Analysis Population Description

ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	148	147
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Week 1 (n=145,147)	-1.35 (0.19)	-1.04 (0.19)
Week 2 (n=139,143)	-1.95 (0.19)	-1.87 (0.19)
Week 6 (n=132,134)	-2.37 (0.19)	-2.25 (0.19)
Week 10 (n=125,128)	-2.32 (0.19)	-2.26 (0.19)
Week 14 (n=116,120)	-2.16 (0.22)	-2.46 (0.21)
Endpoint (n=148,147)	-2.15 (0.20)	-2.23 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 1
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2352
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.31
	Confidence Interval	95%; -0.82 to 0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7607
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.08
	Confidence Interval	95%; -0.60 to 0.44
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 6
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6563
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.12
	Confidence Interval	95%; -0.64 to 0.40
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 10
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8319
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.06
	Confidence Interval	95%; -0.58 to 0.47
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 14
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3086
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.30
	Confidence Interval	95%; -0.28 to 0.89
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Endpoint
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7972
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.07
	Confidence Interval	95%; -0.48 to 0.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood)
Description	Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time Frame	Baseline, Weeks 1,2,6,10,14 and Endpoint

Outcome Measure Data

Analysis Population Description

ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	147	147
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Week 1 (n=144,147)	-1.58 (0.21)	-1.20 (0.20)
Week 2 (n=138,143)	-2.23 (0.23)	-2.06 (0.22)
Week 6 (n=131,134)	-2.60 (0.20)	-2.41 (0.20)
Week 10 (n=125,128)	-2.52 (0.20)	-2.37 (0.20)
Week 14 (n=115,120)	-2.53 (0.22)	-2.76 (0.21)
Endpoint (n=147,147)	-2.31 (0.20)	-2.46 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 1
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1863
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.38
	Confidence Interval	95%; -0.94 to 0.18
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5953
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.16
	Confidence Interval	95%; -0.77 to 0.44
	Parameter Dispersion	Type: Standard Error of the Mean; Value: -0.31
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 6
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5080
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.18
	Confidence Interval	95%; -0.73 to 0.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 10
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5842
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.15
	Confidence Interval	95%; -0.70 to 0.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 14
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4286
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.24
	Confidence Interval	95%; -0.35 to 0.83
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Endpoint
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5766
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.16
	Confidence Interval	95%; -0.40 to 0.71
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments	[Not Specified]

18. Secondary Outcome

Title	Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability)
Description	Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time Frame	Baseline, Weeks 1,2,6,10,14 and Endpoint

Outcome Measure Data

Analysis Population Description

ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	148	147
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Week 1 (n=144,147)	-1.40 (0.21)	-1.23 (0.20)
Week 2 (n=139,142)	-1.84 (0.22)	-1.84 (0.21)
Week 6 (n=132,134)	-2.44 (0.21)	-2.33 (0.20)
Week 10 (n=125,128)	-2.13 (0.20)	-2.33 (0.20)
Week 14 (n=115,120)	-2.09 (0.22)	-2.54 (0.22)
Endpoint (n=148,147)	-2.11 (0.21)	-2.42 (0.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 1
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5493
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.17
	Confidence Interval	95%; -0.73 to 0.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9875
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	95%; -0.58 to 0.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 6
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6931
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.11
	Confidence Interval	95%; -0.68 to 0.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 10
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4614
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.20
	Confidence Interval	95%; -0.34 to 0.75
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 14
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1467
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.45
	Confidence Interval	95%; -0.16 to 1.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.31
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Endpoint
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2819
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.31
	Confidence Interval	95%; -0.25 to 0.87
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments	[Not Specified]

19. Secondary Outcome

Title	Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework)
Description	Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time Frame	Baseline, Weeks 1,2,6,10,14 and Endpoint

Outcome Measure Data

Analysis Population Description

ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	147	147
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Week 1 (n=144,147)	-1.47 (0.19)	-1.42 (0.18)
Week 2 (n=138,143)	-2.10 (0.20)	-1.99 (0.20)
Week 6 (n=130,134)	-2.54 (0.19)	-2.45 (0.19)
Week 10 (n=125,128)	-2.49 (0.20)	-2.36 (0.20)
Week 14 (n=114,120)	-2.21 (0.23)	-2.70 (0.22)
Endpoint (n=147,147)	-2.30 (0.20)	-2.61 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 1
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8727
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	95%; -0.55 to 0.46
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6897
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.11
	Confidence Interval	95%; -0.65 to 0.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 6
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7527
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.08
	Confidence Interval	95%; -0.60 to 0.44
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 10
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6394
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.13
	Confidence Interval	95%; -0.67 to 0.41
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 14
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1188
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.49
	Confidence Interval	95%; -0.13 to 1.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.31
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Endpoint
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2685
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.31
	Confidence Interval	95%; -0.24 to 0.87
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments	[Not Specified]

20. Secondary Outcome

Title	Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People)
Description	Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time Frame	Baseline, Weeks 1,2,6,10,14 and Endpoint

Outcome Measure Data

Analysis Population Description

ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	148	147
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Week 1 (n=145,147)	-1.06 (0.21)	-0.87 (0.20)
Week 2 (n=139,143)	-1.54 (0.22)	-1.39 (0.21)
Week 6 (n=132,134)	-1.91 (0.19)	-1.67 (0.19)
Week 10 (n=126,128)	-1.84 (0.19)	-1.91 (0.19)
Week 14 (n=115,120)	-2.08 (0.20)	-2.10 (0.19)
Endpoint (n=148,147)	-2.00 (0.19)	-1.99 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 1
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4991
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.19
	Confidence Interval	95%; -0.74 to 0.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6094
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.15
	Confidence Interval	95%; -0.73 to 0.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 6
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3669
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.24
	Confidence Interval	95%; -0.76 to 0.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 10
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7641
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.08
	Confidence Interval	95%; -0.43 to 0.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 14
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9428
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	95%; -0.51 to 0.55
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Endpoint
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9508
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	95%; -0.52 to 0.49
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments	[Not Specified]

21. Secondary Outcome

Title	Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep)
Description	Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time Frame	Baseline, Weeks 1,2,6,10,14 and Endpoint

Outcome Measure Data

Analysis Population Description

ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description:	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.	Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
Overall Number of Participants Analyzed	148	147
Least Squares Mean (Standard Error); Unit of Measure: score on scale
Week 1 (n=145,147)	-1.80 (0.18)	-1.12 (0.18)
Week 2 (n=139,142)	-2.22 (0.22)	-1.86 (0.21)
Week 6 (n=131,134)	-3.06 (0.21)	-2.68 (0.21)
Week 10 (n=126,128)	-3.10 (0.22)	-2.71 (0.21)
Week 14 (n=116,120)	-2.65 (0.23)	-2.90 (0.23)
Endpoint (n=148,147)	-2.51 (0.22)	-2.74 (0.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 1
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0073
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.68
	Confidence Interval	95%; -1.18 to -0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Table above shows results of statistical analysis for Week 2
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2202
	Comments	All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.37
	Confidence Interval	95%; -0.96 to 0.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments	[Not Specified]