Randomized, Double-Blind, Multicenter, Placebo-Controlled... | NCT00553475

Randomized, Double-Blind, Multicenter, Placebo-Controlled... | NCT00553475 | Trialant

Arms/Interventions Module

Label	Type	Intervention Names
Placebo	Placebo Comparator	Drug: placebo
Pregabalin 300 mg/day	Experimental	Drug: pregabalin
Pregabalin 600 mg/day	Experimental	Drug: pregabalin

Name	Type	Description	Arm Group Labels	Other Names
placebo	Drug	Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Study Endpoint in Mean Weekly Pain Scores	Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations	Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr).	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Number of Responders	A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change From Baseline at Week 1 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1. Change from baseline: Score at Week 1 minus score at baseline	From baseline to Week 1
Change From Baseline at Week 2 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2. Change from baseline: Score at Week 2 minus score at baseline

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning	The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Nagoya	Aichi-ken		Japan
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31802967	Derived	Alexander J Jr, Edwards RA, Manca L, Grugni R, Bonfanti G, Emir B, Whalen E, Watt S, Brodsky M, Parsons B. Integrating Machine Learning With Microsimulation to Classify Hypothetical, Novel Patients for Predicting Pregabalin Treatment Response Based on Observational and Randomized Data in Patients With Painful Diabetic Peripheral Neuropathy. Pragmat Obs Res. 2019 Oct 31;10:67-76. doi: 10.2147/POR.S214412. eCollection 2019.
30521533

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

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
FG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0007 subjects FG00117 subjects FG00213 subjects
Lack of Efficacy		FG0007 subjects FG0011 subjects FG0020 subjects
Withdrawal by Subject		FG0001 subjects FG0011 subjects FG0020 subjects
Physician Decision		FG0001 subjects FG0010 subjects FG0020 subjects
Due to moving		FG0000 subjects FG0011 subjects FG0020 subjects

Arm/Group Information

ID	Title	Description
BG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
BG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
BG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title

Denominators

Categories

< 18 years

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00061.3± 9.6 BG00161.3± 10.3 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00032 BG00132 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Japan

Title	Measurements
	BG000135 BG001134 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to Study Endpoint in Mean Weekly Pain Scores

Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts
Participants	OG000135 OG001134 OG00245

Title

Denominators

Categories

Title	Measurements
	OG000-1.20± 0.21 OG001-1.82± 0.22 OG002-1.94± 0.32

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	Treatment groups and the CLcr strata as factors and baseline values as covariates.	0.0075		Mean Difference (Final Values)	-0.63				95	-1.09	-0.17					Superiority or Other (legacy)
OG000 OG002

Secondary

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Expected Exposure Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with normal CLcr in the pregabalin 300 mg/day group received pregabalin 300 mg/day for 12 weeks.
OG002	Expected Exposure Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr in the pregabalin 300 and 600 mg/day groups received pregabalin 300 mg/day and subjects with normal CLcr in the pregabalin 600 mg/day group received pregabalin 600 mg/day for 12 weeks.

Primary

Number of Responders

A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.

Full analysis set. Last observation carried forward.

Posted

Number

participants

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts
Participants

Primary

Change From Baseline at Week 1 in Mean Weekly Pain Scores

The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1.

Change from baseline: Score at Week 1 minus score at baseline

Full analysis set. Observed case (No imputation).

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 1

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Primary

Change From Baseline at Week 2 in Mean Weekly Pain Scores

The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2.

Change from baseline: Score at Week 2 minus score at baseline

Full analysis set. Observed case (No imputation).

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 2

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Primary

Change From Baseline at Week 3 in Mean Weekly Pain Scores

The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3.

Change from baseline: Score at Week 3 minus score at baseline

Full analysis set. Observed case (No imputation).

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 3

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Primary

Change From Baseline at Week 4 in Mean Weekly Pain Scores

The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4.

Change from baseline: Score at Week 4 minus score at baseline

Full analysis set. Observed case (No imputation).

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 4

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Primary

Change From Baseline at Week 5 in Mean Weekly Pain Scores

The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5.

Change from baseline: Score at Week 5 minus score at baseline

Full analysis set. Observed case (No imputation).

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 5

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Primary

Change From Baseline at Week 6 in Mean Weekly Pain Scores

The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6.

Change from baseline: Score at Week 6 minus score at baseline

Full analysis set. Observed case (No imputation).

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 6

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Primary

Change From Baseline at Week 7 in Mean Weekly Pain Scores

The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7.

Change from baseline: Score at Week 7 minus score at baseline

Full analysis set. Observed case (No imputation).

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 7

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Primary

Change From Baseline at Week 8 in Mean Weekly Pain Scores

The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8.

Change from baseline: Score at Week 8 minus score at baseline

Full analysis set. Observed case (No imputation).

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 8

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Primary

Change From Baseline at Week 9 in Mean Weekly Pain Scores

The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9.

Change from baseline: Score at Week 9 minus score at baseline

Full analysis set. Observed case (No imputation).

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 9

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Primary

Change From Baseline at Week 10 in Mean Weekly Pain Scores

The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10.

Change from baseline: Score at Week 10 minus score at baseline

Full analysis set. Observed case (No imputation).

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 10

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Primary

Change From Baseline at Week 11 in Mean Weekly Pain Scores

The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11.

Change from baseline: Score at Week 11 minus score at baseline

Full analysis set. Observed case (No imputation).

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 11

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Primary

Change From Baseline at Week 12 in Mean Weekly Pain Scores

The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12.

Change from baseline: Score at Week 12 minus score at baseline

Full analysis set. Observed case (No imputation).

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 12

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Secondary

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Change From Baseline in Mean Sleep Interference Scores

The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Secondary

Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units

Secondary

Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units

Secondary

Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Secondary

Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units

Secondary

Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

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

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

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

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units

Secondary

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

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

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

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

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

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

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units

Secondary

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

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13 or up to study discontinuation (Study Endpoint)

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Clinical Global Impression of Change

Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).

Full analysis set. Last observation carried forward.

Posted

Mean

Standard Deviation

score on scale

Week 13 or up to discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Secondary

Patient Global Impression of Change

The Patient Global Impression of Change is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).

Full analysis set. Last observation carried forward.

Posted

Mean

Standard Deviation

score on scale

Week 13 or up to discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Primary

Change From Baseline at Week 13 in Mean Weekly Pain Scores

The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13.

Change from baseline: Score at Week 13 minus score at baseline

Full analysis set. Observed case (No imputation).

Posted

Least Squares Mean

Standard Error

score on scale

From baseline to Week 13

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.	3	135	50	135
EG001	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.	2	134	71	134
EG002	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.	1	45	36	45

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected135 at risk EG0010 affected134 at risk EG0020 affected45 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected135 at risk EG0010 affected134 at risk EG0020 affected45 at risk
Feeling abnormal	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected135 at risk EG0010 affected134 at risk EG0020 affected45 at risk
Peripheral coldness	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected135 at risk EG0010 affected134 at risk EG0020 affected45 at risk
Pyrexia	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected135 at risk EG0011 affected134 at risk EG0020 affected45 at risk
Herpes zoster	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected135 at risk EG0010 affected134 at risk EG0020 affected45 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected135 at risk EG0010 affected134 at risk EG0021 affected45 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected135 at risk EG0010 affected134 at risk EG0021 affected45 at risk
Brain stem infarction	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected135 at risk EG0011 affected134 at risk EG0020 affected45 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected135 at risk EG0011 affected134 at risk EG0020 affected45 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected135 at risk EG0010 affected134 at risk EG0020 affected45 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected135 at risk EG0014 affected134 at risk EG0023 affected45 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0005 affected135 at risk EG0013 affected134 at risk EG0023 affected45 at risk
Oedema	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected135 at risk EG0014 affected134 at risk EG0023 affected45 at risk
Oedema peripheral	General disorders	MedDRA (11.1)	Systematic Assessment	EG0008 affected135 at risk EG00119 affected134 at risk EG0028 affected45 at risk
Nasopharyngitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00020 affected135 at risk EG00116 affected134 at risk EG0024 affected45 at risk
Weight increased	Investigations	MedDRA (11.1)	Systematic Assessment	EG0005 affected135 at risk EG00117 affected134 at risk EG0027 affected45 at risk
Dizziness	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0009 affected135 at risk EG00126 affected134 at risk EG00218 affected45 at risk
Somnolence	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG00012 affected135 at risk EG00128 affected134 at risk EG00218 affected45 at risk

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases

Ancestor Terms

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

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.8731		Mean Difference (Final Values)	-0.28				95	-3.67	3.12					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.6337		Mean Difference (Final Values)	1.16				95	-3.62	5.94					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.4398		Mean Difference (Final Values)	-2.10				95	-7.44	3.24					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.9153		Mean Difference (Final Values)	-0.41				95	-7.96	7.14					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.4873		Mean Difference (Final Values)	1.50				95	-2.75	5.76					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.4008		Mean Difference (Final Values)	2.56				95	-3.42	8.53					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.5372		Mean Difference (Final Values)	0.98				95	-2.13	4.09					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.3480		Mean Difference (Final Values)	2.09				95	-2.29	6.47					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0544		Mean Difference (Final Values)	5.06				95	-0.10	10.21					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0278		Mean Difference (Final Values)	8.15				95	0.89	15.42					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.7394		Mean Difference (Final Values)	0.92				95	-4.52	6.37					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.5712		Mean Difference (Final Values)	2.22				95	-5.49	9.93					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	Treatment groups as factors and baseline values as covariates	0.0058		Mean Difference (Final Values)	-0.67				95	-1.14	-0.19					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	Treatment groups as factors and baseline values as covariates	0.0333		Mean Difference (Final Values)	-0.64				95	-1.23	-0.05					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Significance level of 0.05 was used.	Cochran-Mantel-Haenszel	stratified by CLcr stratum	0.153							95							Superiority or Other (legacy)
OG000 OG002	Significance level of 0.05 was used.	Cochran-Mantel-Haenszel	stratified by CLcr stratum	0.059							95							Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0287		Mean Difference (Final Values)	-0.43				95	-0.82	-0.05					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0073		Median Difference (Final Values)	-0.75				95	-1.29	-0.20					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0021		Mean Difference (Final Values)	-0.61				95	-1.00	-0.22					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	<0.0001		Mean Difference (Final Values)	-1.23				95	-1.78	-0.69					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0026		Mean Difference (Final Values)	-0.60				95	-0.99	-0.21					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	<0.0001		Mean Difference (Final Values)	-1.13				95	-1.69	-0.58					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0012		Mean Difference (Final Values)	-0.64				95	-1.03	-0.25					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	<0.0001		Mean Difference (Final Values)	-1.11				95	-1.67	-0.56					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0011		Mean Difference (Final Values)	-0.65				95	-1.04	-0.26					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	<0.0001		Mean Difference (Final Values)	-1.16				95	-1.72	-0.60					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	<0.0001		Mean Difference (Final Values)	-0.79				95	-1.18	-0.40					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	<0.0001		Mean Difference (Final Values)	-1.12				95	-1.68	-0.56					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0003		Mean Difference (Final Values)	-0.72				95	-1.12	-0.33					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0002		Mean Difference (Final Values)	-1.09				95	-1.66	-0.52					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0008		Mean Difference (Final Values)	-0.67				95	-1.07	-0.28					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0014		Mean Difference (Final Values)	-0.94				95	-1.51	-0.36					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0003		Mean Difference (Final Values)	-0.73				95	-1.12	-0.33					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0036		Mean Difference (Final Values)	-0.86				95	-1.44	-0.28					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0005		Mean Difference (Final Values)	-0.70				95	-1.10	-0.31					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0034		Mean Difference (Final Values)	-0.87				95	-1.46	-0.29					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0023		Mean Difference (Final Values)	-0.62				95	-1.02	-0.22					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0105		Mean Difference (Final Values)	-0.77				95	-1.36	-0.18					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0016		Mean Difference (Final Values)	-0.65				95	-1.05	-0.25					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0111		Mean Difference (Final Values)	-0.77				95	-1.37	-0.18					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.6118		Mean Difference (Final Values)	-1.07				95	-5.23	3.08					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0109		Mean Difference (Final Values)	7.59				95	1.76	13.42					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.4602		Mean Difference (Final Values)	1.49				95	-2.47	5.45					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.1625		Mean Difference (Final Values)	3.97				95	-1.61	9.54					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	<0.0001		Mean Difference (Final Values)	-0.85				95	-1.25	-0.46					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0273		Mean Difference (Final Values)	-0.63				95	-1.19	-0.07					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0013		Mean Difference (Final Values)	-1.79				95	-2.87	-0.71					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0062		Mean Difference (Final Values)	-2.13				95	-3.65	-0.61					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0068		Mean Difference (Final Values)	-0.60				95	-1.03	-0.17					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0707		Mean Difference (Final Values)	-0.56				95	-1.17	0.05					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0013		Mean Difference (Final Values)	-2.35				95	-3.76	-0.93					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0087		Mean Difference (Final Values)	-2.67				95	-4.67	-0.68					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0056		Mean Difference (Final Values)	-7.27				95	-12.40	-2.14					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0427		Mean Difference (Final Values)	-7.49				95	-14.74	-0.25					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0365		Mean Difference (Final Values)	-0.21				95	-0.40	-0.01					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0073		Mean Difference (Final Values)	-0.37				95	-0.65	-0.10					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0019		Mean Difference (Final Values)	-6.37				95	-10.38	-2.36					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.1907		Mean Difference (Final Values)	-3.78				95	-9.45	1.89					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.9905		Mean Difference (Final Values)	0.03				95	-5.37	5.43					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.2532		Mean Difference (Final Values)	4.44				95	-3.19	12.08					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.4538		Mean Difference (Final Values)	-1.39				95	-5.05	2.26					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.2782		Mean Difference (Final Values)	-2.84				95	-7.97	2.30					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0177		Mean Difference (Final Values)	0.32				95	0.06	0.59					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.3661		Mean Difference (Final Values)	0.17				95	-0.20	0.55					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0511		Mean Difference (Final Values)	5.62				95	-0.03	11.26					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0173		Mean Difference (Final Values)	9.65				95	1.72	17.59					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.1123		Mean Difference (Final Values)	3.79				95	-0.89	8.47					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0206		Mean Difference (Final Values)	7.79				95	1.20	14.38					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.0269		Mean Difference (Final Values)	-3.54				95	-6.67	-0.41					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.4183		Mean Difference (Final Values)	-1.82				95	-6.24	2.60					Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Cochran-Mantel-Haenszel	Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr	0.0148							95							Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Cochran-Mantel-Haenszel	Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr	0.0063							95							Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Cochran-Mantel-Haenszel	Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr	0.0818							95							Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Cochran-Mantel-Haenszel	Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr	0.0075							95							Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0013		Mean Difference (Final Values)	-0.66				95	-1.07	-0.26					Superiority or Other (legacy)
OG000 OG002	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	Mixed Model Repeated Measures Analysis	Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.	0.0152		Mean Difference (Final Values)	-0.74				95	-1.34	-0.14					Superiority or Other (legacy)