5% Topical Ibuprofen (IBU) for Ankle Sprain | NCT01945034

Label	Type	Intervention Names
Topical IBU twice daily	Experimental	Drug: Topical IBU twice daily
Placebo twice daily	Placebo Comparator	Drug: Placebo twice daily
Topical IBU three times daily	Experimental	Drug: Topical IBU three times daily
Placebo three times daily	Placebo Comparator	Drug: Placebo three times daily

Name	Type	Description	Arm Group Labels	Other Names
Topical IBU twice daily	Drug	Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days	Topical IBU twice daily

Measure	Description	Time Frame
Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)	PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.	Over 3 Days (0-72 hours)
Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)	PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.	0 to 24 hours

Measure	Description	Time Frame
Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)	PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -240 (higher pain relief) to 96 (lower pain relief) for SPID at rest. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.

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

Facility	Status	City	State	ZIP	Country	Contacts
Helen Keller Hospital		Sheffield	Alabama	35660	United States
Visions Clinical Research - Tucson

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

ID	Title	Description
FG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
FG001

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

Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)

PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.

Posted

Least Squares Mean

Standard Error

units on a scale

Over 3 Days (0-72 hours)

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG002	Placebo Combined	Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.

Units	Counts
Participants	OG00067 OG00185 OG002152

Title

Denominators

Categories

Title	Measurements
	OG000188.9± 14.81 OG001173.6± 13.6 OG002165.9± 10.34

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 OG002	The analysis of variance (ANOVA) model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA		0.190	p-value <=0.05 for treatment effects	LS Mean Difference	23			2-Sided	95	-11.49	57.56				No	Superiority or Other

Primary

Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)

PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.

Posted

Least Squares Mean

Standard Error

units on a scale

0 to 24 hours

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.

Secondary

Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)

PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -240 (higher pain relief) to 96 (lower pain relief) for SPID at rest. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.

Posted

Least Squares Mean

Standard Error

units on a scale

0 to 24 hours

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.

Secondary

Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10

Participant's global assessments of ankle injury was measured using 5-point scale: 1= Very Good (No symptoms and no limitations of normal activities), 2= Good (Mild symptoms and no limitation of normal activities), 3= Fair (Moderate symptoms and limitations of some normal activities), 4= Poor (Severe symptoms and inability to carry out most normal activities), 5= Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Day 3, 10

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.

Secondary

Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10

The physician assessment of the severity of the ankle injury was based on the participant's individual signs and symptoms which included pain, swelling, tenderness and limitation of range of movement, and was measured using 6-point scale: 0= Normal (No signs or symptoms) , 1= Very mild (Very mild signs and symptoms), 2= Mild (Mild signs and symptoms), 3= Moderate (Moderate signs and symptoms), 4= Severe (Severe signs and symptoms), 5= Very severe (Very severe signs and symptoms). A higher score is indicative of lesser improvement. Change from baseline was calculated as baseline value minus post-treatment value.

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Day 3, 10

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.

Secondary

Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points

PI in ankle pain at rest and upon weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline.

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, 1, 2, 3, 4, 5, 6, 12(Day1),24(Day2),30(Day2),36(Day2),48(Day3),50(Day3),54(Day3),60(Day3),72(Day4),78(Day4),84(Day4), 96(Day5),102(Day5), 108 (Day5), 120(Day6),126(Day6),132(Day6),144(Day7),150(Day7),156(Day7) hours post first dose on Day 1

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.

Secondary

Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3

PI at rest and on weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID 0-6 was calculated as the time-weighted sum of PID scores over 6 hours on Day 1, with a total score ranges from -30 (higher pain relief) to 36 (lower pain relief). SPID 0-12 was calculated as the time weighted sum of PID scores over 2 hours on Day 3, with a total score ranges from -10 (higher pain relief) to 12 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.

Posted

Least Squares Mean

Standard Error

units on a scale

Over 6 hours on Day 1, over 2 hours on Day 3

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001

Secondary

Sum of Pain Intensity Difference Scores at Rest Over 3 Days

PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.

Posted

Least Squares Mean

Standard Error

Units on a scale

Over 3 Days (0-72 hours)

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.

Secondary

Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days

PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 7 days (168 hours). Total score ranges from -840 (higher pain relief) to 1008 (lower pain relief). SPID is a value of change from baseline. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.

Posted

Least Squares Mean

Standard Error

Units on a scale

Over 7 days (0-168 hours)

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.

Secondary

Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10

Participant assessment of normal function was measured using a 5-point scale: 1= Normal walking/activity and no pain; 2= Normal walking/activity with pain; 3= Mildly restricted walking due to pain and can't resume normal activities; 4= Moderately restricted walking due to pain and can't resume normal activities; 5= Severely restricted walking due to pain and can't resume normal activities. The normal functioning and activity scores for each question range from 1 to 5, with higher scores indicating worsening of normal activity.

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline, Day 3, 10

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.

Secondary

Participant's Global Assessment of Medication at End of Study

Participants Global Assessment of Medication was used to rate the medication as a pain reliever. The responses of participants were recorded using 5-point scale: 1= Very Poor, 2= Poor, 3= Fair, 4= Good, 5= Very Good. The global assessment of medication scores for each question range from 0 to 5, giving a possible score range of 0 - 5, with higher scores indicating medication as a better pain reliever.

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment. Number of participants analyzed 'N' signifies those participants who were evaluable for the measure.

Posted

Mean

Standard Deviation

Units on a scale

Day 10

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.

Secondary

Time to First Perceptible Relief and Meaningful Relief

Participants evaluated time to first perceptible relief by stopping a stopwatch labelled 'first perceptible relief' at moment participant first began to experience any relief, exact question asked was: "Stop stopwatch when you first begin to feel any pain-relieving effect whatsoever of product; that is, when you first feel a little relief". First perceptible relief was considered confirmed by meaningful relief if participant achieved both "first perceptible" and "meaningful" relief by either pressing second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful". For "time to meaningful relief," exact question asked was: "Stop this stopwatch when you have meaningful relief; that is, when relief from pain is meaningful to you." Stopwatches were active up to 3 hours after dosing or until stopped by participant, or rescue medication was administered.

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.

Posted

Median

95% Confidence Interval

Minutes

0 to 3 hours on Day 1

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily

Secondary

Time to Rescue Medication After Initial Dose, and After Each Subsequent Dose

Participants used only acetaminophen at a dose of 500 milligram (mg) every 6 hours product as needed (PRN) as rescue medication during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary. Time to rescue medication after initial dose, after each subsequent dose, provided that in each dose interval at least 25% of the participants take rescue medication was analyzed using the proportional hazard model with site, treatment group, and baseline categorical ankle pain terms in the model.

Data was not analyzed since <20% participants used rescue medication.

Posted

Post-Dose on Day 1 up to Day 10

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.

Secondary

Number of Doses of Rescue Medication Used During the First 7 Days of Dosing

Participants received only acetaminophen 500 mg every 6 hours PRN as rescue medication during the course of the study.

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.

Posted

Mean

Standard Deviation

Doses

Baseline up to Day 7

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG002	Placebo Combined	Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.

Secondary

Percentage of Participants Taking Rescue Medication

Participants used only acetaminophen at a dose of 500 mg every 6 hours PRN as analgesia or rescue therapy during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary.

The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.

Posted

Number

Percentage of participants

Post first dose Day 1 up to Day 10

ID	Title	Description
OG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
OG002	Placebo Combined

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA		0.771	LS Mean Difference	0.1	2-Sided	95	-0.38	0.51	No	Superiority or Other
OG001 OG002	At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.022	LS Mean Difference	-0.5	2-Sided	95	-0.88	-0.07	No	Superiority or Other
OG000 OG001	At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.032	LS Mean Difference	-0.5	2-Sided	95	-1.03	-0.05	No	Superiority or Other
OG000 OG002	Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.720	LS Mean Difference	0.1	2-Sided	95	-0.38	0.55	No	Superiority or Other
OG001 OG002	Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.194	LS Mean Difference	-0.3	2-Sided	95	-0.71	0.15	No	Superiority or Other
OG000 OG001	Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.163	LS Mean Difference	-0.4	2-Sided	95	-0.89	0.15	No	Superiority or Other
OG000 OG002	At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.644	LS Mean Difference	0.1	2-Sided	95	-0.40	0.64	No	Superiority or Other
OG001 OG002	At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.129	LS Mean Difference	-0.4	2-Sided	95	-0.85	0.11	No	Superiority or Other
OG000 OG001	At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.096	LS Mean Difference	-0.5	2-Sided	95	-1.07	0.09	No	Superiority or Other
OG000 OG002	Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.905	LS Mean Difference	0.0	2-Sided	95	-0.50	0.57	No	Superiority or Other
OG001 OG002	Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.279	LS Mean Difference	-0.3	2-Sided	95	-0.77	0.22	No	Superiority or Other
OG000 OG001	Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.315	LS Mean Difference	-0.3	2-Sided	95	-0.90	0.29	No	Superiority or Other
OG000 OG002	At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.203	LS Mean Difference	0.4	2-Sided	95	-0.19	0.91	No	Superiority or Other
OG001 OG002	At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.207	LS Mean Difference	-0.3	2-Sided	95	-0.83	0.18	No	Superiority or Other
OG000 OG001	At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.030	LS Mean Difference	-0.7	2-Sided	95	-1.30	-0.07	No	Superiority or Other
OG000 OG002	Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.372	LS Mean Difference	0.3	2-Sided	95	-0.32	0.84	No	Superiority or Other
OG001 OG002	Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.532	LS Mean Difference	-0.2	2-Sided	95	-0.70	0.36	No	Superiority or Other
OG000 OG001	Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.189	LS Mean Difference	-0.4	2-Sided	95	-1.08	0.21	No	Superiority or Other
OG000 OG002	At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.264	LS Mean Difference	0.3	2-Sided	95	-0.24	0.87	No	Superiority or Other
OG001 OG002	At Rest 4 hour Day 1:The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.260	LS Mean Difference	-0.3	2-Sided	95	-0.81	0.22	No	Superiority or Other
OG000 OG001	At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.054	LS Mean Difference	-0.6	2-Sided	95	-1.23	0.01	No	Superiority or Other
OG000 OG002	Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.456	LS Mean Difference	0.2	2-Sided	95	-0.37	0.81	No	Superiority or Other
OG001 OG002	Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.639	LS Mean Difference	0.1	2-Sided	95	-0.42	0.68	No	Superiority or Other
OG000 OG001	Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.780	LS Mean Difference	-0.1	2-Sided	95	-0.75	0.57	No	Superiority or Other
OG000 OG002	At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.071	LS Mean Difference	0.5	2-Sided	95	-0.04	1.07	No	Superiority or Other
OG001 OG002	At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.468	LS Mean Difference	-0.2	2-Sided	95	-0.70	0.32	No	Superiority or Other
OG000 OG001	At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.027	LS Mean Difference	-0.7	2-Sided	95	-1.33	-0.08	No	Superiority or Other
OG000 OG002	Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.107	LS Mean Difference	0.5	2-Sided	95	-0.11	1.09	No	Superiority or Other
OG001 OG002	Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.947	LS Mean Difference	-0.0	2-Sided	95	-0.57	0.53	No	Superiority or Other
OG000 OG001	Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.134	LS Mean Difference	-0.5	2-Sided	95	-1.18	0.16	No	Superiority or Other
OG000 OG002	At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.017	LS Mean Difference	0.7	2-Sided	95	0.12	1.23	No	Superiority or Other
OG001 OG002	At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.715	LS Mean Difference	-0.1	2-Sided	95	-0.60	0.41	No	Superiority or Other
OG000 OG001	At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.015	LS Mean Difference	-0.8	2-Sided	95	-1.39	-0.15	No	Superiority or Other
OG000 OG002	Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.027	LS Mean Difference	0.7	2-Sided	95	0.07	1.23	No	Superiority or Other
OG001 OG002	Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.660	LS Mean Difference	0.1	2-Sided	95	-0.42	0.65	No	Superiority or Other
OG000 OG001	Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.107	LS Mean Difference	-0.5	2-Sided	95	-1.18	0.11	No	Superiority or Other
OG000 OG002	At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.020	LS Mean Difference	0.6	2-Sided	95	0.10	1.13	No	Superiority or Other
OG001 OG002	At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.749	LS Mean Difference	-0.1	2-Sided	95	-0.55	0.40	No	Superiority or Other
OG000 OG001	At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.019	LS Mean Difference	-0.7	2-Sided	95	-1.27	-0.12	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.163	LS Mean Difference	0.4	2-Sided	95	-0.16	0.96	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.727	LS Mean Difference	0.1	2-Sided	95	-0.43	0.61	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.336	LS Mean Difference	-0.3	2-Sided	95	-0.94	0.32	No	Superiority or Other
OG000 OG002	At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.174	LS Mean Difference	0.4	2-Sided	95	-0.16	0.87	No	Superiority or Other
OG001 OG002	At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.277	LS Mean Difference	-0.3	2-Sided	95	-0.73	0.21	No	Superiority or Other
OG000 OG001	At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.035	LS Mean Difference	-0.6	2-Sided	95	-1.19	-0.04	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.858	LS Mean Difference	0.1	2-Sided	95	-0.50	0.60	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.724	LS Mean Difference	-0.1	2-Sided	95	-0.60	0.42	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.651	LS Mean Difference	-0.1	2-Sided	95	-0.76	0.48	No	Superiority or Other
OG000 OG002	At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.059	LS Mean Difference	0.5	2-Sided	95	-0.02	1.05	No	Superiority or Other
OG001 OG002	At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.766	LS Mean Difference	-0.1	2-Sided	95	-0.57	0.42	No	Superiority or Other
OG000 OG001	At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.053	LS Mean Difference	-0.6	2-Sided	95	-1.19	0.01	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.212	LS Mean Difference	0.4	2-Sided	95	-0.21	0.92	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.911	LS Mean Difference	0.0	2-Sided	95	-0.49	0.55	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.305	LS Mean Difference	-0.3	2-Sided	95	-0.96	0.30	No	Superiority or Other
OG000 OG002	At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.075	LS Mean Difference	0.5	2-Sided	95	-0.05	1.02	No	Superiority or Other
OG001 OG002	At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.684	LS Mean Difference	0.1	2-Sided	95	-0.39	0.60	No	Superiority or Other
OG000 OG001	At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.208	LS Mean Difference	-0.4	2-Sided	95	-0.98	0.21	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.304	LS Mean Difference	0.3	2-Sided	95	-0.27	0.85	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.356	LS Mean Difference	0.2	2-Sided	95	-0.27	0.76	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.876	LS Mean Difference	-0.0	2-Sided	95	-0.67	0.58	No	Superiority or Other
OG000 OG002	At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.020	LS Mean Difference	0.6	2-Sided	95	0.10	1.15	No	Superiority or Other
OG001 OG002	At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.940	LS Mean Difference	-0.0	2-Sided	95	-0.50	0.47	No	Superiority or Other
OG000 OG001	At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.032	LS Mean Difference	-0.6	2-Sided	95	-1.23	-0.06	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.206	LS Mean Difference	0.4	2-Sided	95	-0.21	0.95	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.310	LS Mean Difference	0.3	2-Sided	95	-0.26	0.81	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.771	LS Mean Difference	-0.1	2-Sided	95	-0.74	0.55	No	Superiority or Other
OG000 OG002	At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.016	LS Mean difference	0.7	2-Sided	95	0.13	1.24	No	Superiority or Other
OG001 OG002	At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.905	LS Mean Difference	0.0	2-Sided	95	-0.48	0.54	No	Superiority or Other
OG000 OG001	At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.039	LS Mean Difference	-0.7	2-Sided	95	-1.28	-0.03	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.276	LS Mean Difference	0.3	2-Sided	95	-0.27	0.93	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.343	LS Mean Difference	0.3	2-Sided	95	-0.29	0.82	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.849	LS Mean Difference	-0.1	2-Sided	95	-0.73	0.60	No	Superiority or Other
OG000 OG002	At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.009	LS Mean Difference	0.7	2-Sided	95	0.19	1.29	No	Superiority or Other
OG001 OG002	At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.763	LS Mean Difference	-0.1	2-Sided	95	-0.58	0.43	No	Superiority or Other
OG000 OG001	At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.010	LS Mean Difference	-0.8	2-Sided	95	-1.43	-0.20	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.105	LS Mean Difference	0.5	2-Sided	95	-0.10	1.09	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.533	LS Mean Difference	0.2	2-Sided	95	-0.38	0.73	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.348	LS Mean Difference	-0.3	2-Sided	95	-0.99	0.35	No	Superiority or Other
OG000 OG002	At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.016	LS Mean Difference	0.7	2-Sided	95	0.13	1.23	No	Superiority or Other
OG001 OG002	At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.483	LS Mean Difference	-0.2	2-Sided	95	-0.69	0.33	No	Superiority or Other
OG000 OG001	At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.006	LS Mean Difference	-0.9	2-Sided	95	-1.47	-0.25	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.177	LS Mean Difference	0.4	2-Sided	95	-0.19	1.00	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.586	LS Mean Difference	0.2	2-Sided	95	-0.40	0.70	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.448	LS Mean Difference	-0.3	2-Sided	95	-0.92	0.41	No	Superiority or Other
OG000 OG002	At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.043	LS Mean Difference	0.6	2-Sided	95	0.02	1.09	No	Superiority or Other
OG001 OG002	At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.688	LS Mean Difference	-0.1	2-Sided	95	-0.59	0.39	No	Superiority or Other
OG000 OG001	At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.032	LS Mean Difference	-0.7	2-Sided	95	-1.25	-0.06	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 4(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.179	LS Mean Difference	0.4	2-Sided	95	-0.19	0.99	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.609	LS Mean Difference	0.1	2-Sided	95	-0.40	0.69	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.435	LS Mean Difference	-0.3	2-Sided	95	-0.92	0.40	No	Superiority or Other
OG000 OG002	At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.023	LS Mean Difference	0.7	2-Sided	95	0.10	1.26	No	Superiority or Other
OG001 OG002	At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.987	LS Mean Difference	-0.0	2-Sided	95	-0.54	0.53	No	Superiority or Other
OG000 OG001	At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.040	LS Mean Difference	-0.7	2-Sided	95	-1.33	-0.03	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.319	LS Mean Difference	0.3	2-Sided	95	-0.31	0.94	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.712	LS Mean Difference	0.1	2-Sided	95	-0.47	0.69	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.557	LS Mean Difference	-0.2	2-Sided	95	-0.91	0.49	No	Superiority or Other
OG000 OG002	At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.015	LS Mean Difference	0.7	2-Sided	95	0.14	1.28	No	Superiority or Other
OG001 OG002	At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.326	LS Mean Difference	0.3	2-Sided	95	-0.26	0.79	No	Superiority or Other
OG000 OG001	At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.167	LS Mean Difference	-0.4	2-Sided	95	-1.08	0.19	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.350	LS Mean Difference	0.3	2-Sided	95	-0.33	0.93	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.235	LS Mean Difference	0.4	2-Sided	95	-0.23	0.93	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 4(PM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.881	LS Mean Difference	0.1	2-Sided	95	-0.65	0.76	No	Superiority or Other
OG000 OG002	At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.036	LS Mean Difference	0.6	2-Sided	95	0.04	1.16	No	Superiority or Other
OG001 OG002	At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.656	LS Mean Difference	0.1	2-Sided	95	-0.40	0.63	No	Superiority or Other
OG000 OG001	At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.130	LS Mean Difference	-0.5	2-Sided	95	-1.11	0.14	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.304	LS Mean Difference	0.3	2-Sided	95	-0.30	0.95	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.491	LS Mean Difference	0.2	2-Sided	95	-0.37	0.78	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.726	LS Mean Difference	-0.1	2-Sided	95	-0.82	0.57	No	Superiority or Other
OG000 OG002	At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.029	LS Mean Difference	0.6	2-Sided	95	0.07	1.23	No	Superiority or Other
OG001 OG002	At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.585	LS Mean Difference	0.1	2-Sided	95	-0.39	0.68	No	Superiority or Other
OG000 OG001	At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.131	LS Mean Difference	-0.5	2-Sided	95	-1.15	0.15	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.215	LS Mean Difference	0.4	2-Sided	95	-0.24	1.04	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.244	LS Mean Difference	0.3	2-Sided	95	-0.24	0.94	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.885	LS Mean Difference	-0.1	2-Sided	95	-0.76	0.66	No	Superiority or Other
OG000 OG002	At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.067	LS Mean Difference	0.5	2-Sided	95	-0.04	1.13	No	Superiority or Other
OG001 OG002	At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.500	LS Mean Difference	0.2	2-Sided	95	-0.35	0.73	No	Superiority or Other
OG000 OG001	At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.276	LS Mean Difference	-0.4	2-Sided	95	-1.02	0.29	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.413	LS Mean Difference	0.3	2-Sided	95	-0.38	0.92	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.448	LS Mean Difference	0.2	2-Sided	95	-0.37	0.83	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.917	LS Mean Difference	-0.0	2-Sided	95	-0.76	0.69	No	Superiority or Other
OG000 OG002	At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.132	LS Mean Difference	0.4	2-Sided	95	-0.13	1.03	No	Superiority or Other
OG001 OG002	At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.505	LS Mean Difference	0.2	2-Sided	95	-0.35	0.72	No	Superiority or Other
OG000 OG001	At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.422	LS Mean Difference	-0.3	2-Sided	95	-0.92	0.38	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.747	LS Mean Difference	0.1	2-Sided	95	-0.54	0.76	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.386	LS Mean Difference	0.3	2-Sided	95	-0.34	0.87	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.668	LS Mean Difference	0.2	2-Sided	95	-0.57	0.89	No	Superiority or Other
OG000 OG002	At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.099	LS Mean Difference	0.5	2-Sided	95	-0.09	1.08	No	Superiority or Other
OG001 OG002	At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.365	LS Mean Difference	0.2	2-Sided	95	-0.29	0.79	No	Superiority or Other
OG000 OG001	At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.463	LS Mean Difference	-0.2	2-Sided	95	-0.90	0.41	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.845	LS Mean Difference	0.1	2-Sided	95	-0.60	0.73	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.199	LS Mean Difference	0.4	2-Sided	95	-0.21	1.02	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.375	LS Mean Difference	0.3	2-Sided	95	-0.41	1.08	No	Superiority or Other
OG000 OG002	At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.028	LS Mean Difference	0.7	2-Sided	95	0.07	1.27	No	Superiority or Other
OG001 OG002	At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.188	LS Mean Difference	0.4	2-Sided	95	-0.18	0.92	No	Superiority or Other
OG000 OG001	At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.375	LS Mean Difference	-0.3	2-Sided	95	-0.97	0.37	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.552	LS Mean Difference	0.2	2-Sided	95	-0.47	0.89	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.126	LS Mean Difference	0.5	2-Sided	95	-0.14	1.12	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.460	LS Mean Difference	0.3	2-Sided	95	-0.47	1.05	No	Superiority or Other
OG000 OG002	At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.095	LS Mean Difference	0.5	2-Sided	95	-0.09	1.09	No	Superiority or Other
OG001 OG002	At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.146	LS Mean Difference	0.4	2-Sided	95	-0.14	0.94	No	Superiority or Other
OG000 OG001	At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.769	LS Mean Difference	-0.1	2-Sided	95	-0.75	0.56	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.405	LS Mean Difference	0.3	2-Sided	95	-0.39	0.96	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.073	LS Mean Difference	0.6	2-Sided	95	-0.05	1.20	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.458	LS Mean Difference	0.3	2-Sided	95	-0.47	1.04	No	Superiority or Other
OG000 OG002	At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.009	LS Mean Difference	0.8	2-Sided	95	0.20	1.39	No	Superiority or Other
OG001 OG002	At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.209	LS Mean Difference	0.4	2-Sided	95	-0.20	0.90	No	Superiority or Other
OG000 OG001	At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.193	LS Mean Difference	-0.4	2-Sided	95	-1.11	0.22	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.149	LS Mean Difference	0.5	2-Sided	95	-0.18	1.18	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.186	LS Mean Difference	0.4	2-Sided	95	-0.21	1.06	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.845	LS Mean Difference	-0.1	2-Sided	95	-0.84	0.69	No	Superiority or Other
OG000 OG002	At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.067	LS Mean Difference	0.5	2-Sided	95	-0.04	1.14	No	Superiority or Other
OG001 OG002	At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.242	LS Mean Difference	0.3	2-Sided	95	-0.22	0.87	No	Superiority or Other
OG000 OG001	At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.	ANOVA	p-value <=0.05 for treatment effects	0.498	LS Mean Difference	-0.2	2-Sided	95	-0.88	0.43	No	Superiority or Other
OG000 OG002	Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.330	LS Mean Difference	0.3	2-Sided	95	-0.34	1.02	No	Superiority or Other
OG001 OG002	Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.	ANOVA	p-value <=0.05 for treatment effects	0.124	LS Mean Difference	0.5	2-Sided	95	-0.14	1.13	No	Superiority or Other
OG000 OG001	Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.	ANOVA	p-value <=0.05 for treatment effects	0.687	LS Mean Difference	0.2	2-Sided	95	-0.61	0.92	No	Superiority or Other

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Eye irritation	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected85 at risk EG0021 affected152 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected85 at risk EG0021 affected152 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected85 at risk EG0021 affected152 at risk
Toothache	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected85 at risk EG0020 affected152 at risk
Oedema peripheral	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected85 at risk EG0021 affected152 at risk
Application site erythema	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected85 at risk EG0021 affected152 at risk
Influenza like illness	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected85 at risk EG0020 affected152 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected85 at risk EG0021 affected152 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected85 at risk EG0020 affected152 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected85 at risk EG0021 affected152 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected85 at risk EG0021 affected152 at risk
Metatarsalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected85 at risk EG0021 affected152 at risk
Headache	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected85 at risk EG0024 affected152 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected85 at risk EG0020 affected152 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected85 at risk EG0021 affected152 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected67 at risk EG0012 affected85 at risk EG0020 affected152 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected85 at risk EG0021 affected152 at risk
Sticky skin	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected85 at risk EG0021 affected152 at risk

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries

ID	Title	Description
BG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
BG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
BG002	Placebo Combined	Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ibuprofen Twice Daily	Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.	1	67	4	67
EG001	Ibuprofen Thrice Daily	Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.	0	85	5	85
EG002	Placebo Combined	Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.	0	152	13	152