Evaluation of the Efficacy of Novel Ibuprofen Acetaminoph... | NCT01559259

Label	Type	Intervention Names
Ibuprofen/acetaminophen (lower dose)	Experimental	Drug: Ibuprofen/acetaminophen
Ibuprofen/acetaminophen (middle dose)	Experimental	Drug: Ibuprofen/acetaminophen
Ibuprofen/acetaminophen (high dose)	Experimental	Drug: Ibuprofen/acetaminophen
Ibuprofen	Active Comparator	Drug: Ibuprofen
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Ibuprofen/acetaminophen	Drug	Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg	Ibuprofen/acetaminophen (lower dose)

Measure	Description	Time Frame
Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)	SPRID4:Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) based on 4 point categorical severity rating scale (PRID) over 8 hours.SPRID 0-8 score range:-8 (worst score) to 56 (best score).PRID: sum of PRR and PID at each time point.PRID score range:-1= worst score to 7= best score.PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [none] to 3 [severe]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).PRR assessed on 5-point categorical scale with range:0 =no relief to 4 =complete relief.	From 0 hour up to 8 hours post-dose

Measure	Description	Time Frame
Time to Onset of Meaningful Pain Relief	Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.

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

Facility	Status	City	State	ZIP	Country	Contacts
Jean Brown Research		Salt Lake City	Utah	84124	United States

PubMed Identifier	Type	Citation	Retractions
32506309	Derived	Kellstein D, Leyva R. Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study. Drugs R D. 2020 Sep;20(3):237-247. doi: 10.1007/s40268-020-00310-7.

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

ID	Title	Description
FG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
FG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.

ID	Title	Description
BG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
BG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
BG002	Ibuprofen 250 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
BG003	Ibuprofen 300 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
BG004	Ibuprofen 400 mg	Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.
BG005	Total	Total of all reporting groups

Units	Counts
Participants	BG00030 BG00190 BG00293 BG00389 BG00492 BG005394

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

Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)

SPRID4:Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) based on 4 point categorical severity rating scale (PRID) over 8 hours.SPRID 0-8 score range:-8 (worst score) to 56 (best score).PRID: sum of PRR and PID at each time point.PRID score range:-1= worst score to 7= best score.PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [none] to 3 [severe]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).PRR assessed on 5-point categorical scale with range:0 =no relief to 4 =complete relief.

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Mean

Standard Deviation

units on a scale

From 0 hour up to 8 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG002	Ibuprofen 250 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG003	Ibuprofen 300 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG004	Ibuprofen 400 mg	Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.

Units	Counts
Participants	OG00030 OG00190 OG00293 OG003

Title

Denominators

Categories

Title	Measurements
	OG0005.0± 13.2 OG00130.8± 12.7 OG00229.6± 15.6 OG003

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	Treatment difference and 95 percent (%) Confidence interval (CI) were based on Least square mean (LSM) from analysis of variance (ANOVA) with treatment, baseline categorical pain severity rating (PSR), gender and treatment-by-baseline categorical PSR terms used as covariates.	ANOVA		<0.001		Least Square (LS) Mean difference	26.28			2-Sided	95	20.33	32.22					Superiority or Other (legacy)

Secondary

Time to Onset of Meaningful Pain Relief

Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Median

95% Confidence Interval

minutes

From 0 hour up to 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG002	Ibuprofen 250 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.

Secondary

Time to Confirmed First Perceptible Relief

Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure (defined as participant taking rescue medication, or discontinuing due to lack of efficacy) prior to depressing the first stopwatch or until the time of withdrawal (discontinuation).

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Median

95% Confidence Interval

minutes

From 0 hour up to 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG002	Ibuprofen 250 mg + Acetaminophen 500 mg

Secondary

Pain Relief Rating Score (PRR)

Participants answered a question: "how much relief do you have from your starting pain? on a 5-point categorical pain relief rating scale. Scale ranges from 0= no relief to 4= complete relief.

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Mean

Standard Deviation

units on a scale

0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG002	Ibuprofen 250 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG003	Ibuprofen 300 mg + Acetaminophen 500 mg

Secondary

Pain Intensity Difference on 4-Point Categorical Scale (PID4)

PID4: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on a 4-point categorical pain severity rating scale. PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score).

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Mean

Standard Deviation

units on a scale

0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG002	Ibuprofen 250 mg + Acetaminophen 500 mg

Secondary

Pain Intensity Difference on 11-Point Numerical Scale (PID11)

PID11: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on an 11-point numerical pain severity rating scale. PID11 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID11: -5 (worst score) to 10 (best score).

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Mean

Standard Deviation

units on a scale

0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG002	Ibuprofen 250 mg + Acetaminophen 500 mg

Secondary

Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)

PRID4: sum of PID and PRR at each post-dose time points up to 12 hours. Score range for PRID: -1(worst score) to 7(best score). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Mean

Standard Deviation

units on a scale

0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG002

Secondary

Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose

Pain intensity was assessed on a 4-point categorical pain severity rating scale. SPID4: Time-weighted sum of PID over post-dose time points. SPID4 score range was -2 (worst score) to 6 (best score) for SPID 0-2, -6 (worst score) to 18 (best score) for SPID 0-6, -8 (worst score) to 24 (best score) for SPID 0-8, -12 (worst score) to 36 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [none] to 3 [severe]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Mean

Standard Deviation

units on a scale

0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.

Secondary

Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose

Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11: Time-weighted sum of PID scores over 12 hours. SPID11 score range was -10 (worst score) to 20 (best score) for SPID 0-2, -30 (worst score) to 60 (best score) for SPID 0-6, -40 (worst score) to 80 (best score) for SPID 0-8, -60 (worst score) to 120 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Mean

Standard Deviation

units on a scale

0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.

Secondary

Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose

TOTPAR: time-weighted sum of PRR scores over 2, 6, 8 and 12 hours. TOTPAR score range was 0 (worst score) to 8 (best score) for TOTPAR 0-2, 0 (worst score) to 24 (best score) for TOTPAR 0-6, 0 (worst score) to 32 (best score) for TOTPAR 0-8, 0 (worst score) to 48 (best score) for TOTPAR 0-12. PRR was assessed on a 5-point categorical pain relief rating scale where 0= No relief to 4= Complete relief.

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Mean

Standard Deviation

units on a scale

0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG002	Ibuprofen 250 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.

Secondary

Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose

SPRID4: Time-weighted sum of PRR and PID based on 4 point categorical pain severity rating scale (PRID) with score range: -2(worst score) to 14 (best score) for SPRID 0-2, -6 (worst score) to 42 (best score) for SPRID 0-6 and -12 (worst score) to 84 (best score) for SPRID 0-12. PRID: sum of PID and PRR at post-dose time point with score range: -1 (worst score) to 7 (best score). PID calculated by subtracting pain intensity score at post-dose time points (score range: 0 [none] to 3 [severe]) from baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline score of at least moderate were included). PID total possible score range: -1 (worst score) to 3(best score). PRR assessed on 5-point categorical scale with range: 0 =no relief to 4 =complete relief.

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Mean

Standard Deviation

units on a scale

0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.

Secondary

Cumulative Percentage of Participants With Meaningful Relief

Percentage of participants with meaningful relief was reported. Participants evaluated time to meaningful relief by stopping a second stopwatch labeled "meaningful relief" at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Number

percentage of participants

0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG002	Ibuprofen 250 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.

Secondary

Cumulative Percentage of Participants With Confirmed First Perceptible Relief

Percentage of participants with confirmed first perceptible relief was reported. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Number

percentage of participants

0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.

Secondary

Time to Treatment Failure

Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure. Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first.

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Median

95% Confidence Interval

hours

From 0 hour up to 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG002	Ibuprofen 250 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.

Secondary

Cumulative Percentage of Participants With Treatment Failure

Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Number

percentage of participants

1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG002	Ibuprofen 250 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.

Secondary

Participant Global Evaluation of Study Medication

Participant global evaluation of study medication was performed at the 12-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0= Very poor, 1= Poor, 2= Fair, 3= Good, 4= Very Good and 5= Excellent.

ITT population included all randomized participants who received study medication and provided a baseline assessment.

Posted

Mean

Standard Deviation

units on a scale

12 hour

ID	Title	Description
OG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.
OG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG002	Ibuprofen 250 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.
OG003	Ibuprofen 300 mg + Acetaminophen 500 mg

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.571	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	1.08	2-Sided	95	-1.04	3.20	Superiority or Other (legacy)
OG000 OG002	0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.593	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	0.98	2-Sided	95	-0.94	2.90	Superiority or Other (legacy)
OG000 OG003	0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.282	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	3.65	2-Sided	95	-0.39	7.68	Superiority or Other (legacy)
OG000 OG004	0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.552	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	1.16	2-Sided	95	-1.11	3.42	Superiority or Other (legacy)
OG001 OG004	0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.994	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	-0.01	2-Sided	95	-3.13	3.11	Superiority or Other (legacy)
OG002 OG004	0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.879	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	-0.23	2-Sided	95	-3.26	2.80	Superiority or Other (legacy)
OG003 OG004	0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.280	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	2.33	2-Sided	95	-1.98	6.64	Superiority or Other (legacy)
OG000 OG001	0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	33.67	2-Sided	95	24.54	42.81	Superiority or Other (legacy)
OG000 OG002	0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.003	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	23.34	2-Sided	95	14.93	31.75	Superiority or Other (legacy)
OG000 OG003	0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.005	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	22.28	2-Sided	95	13.55	31.00	Superiority or Other (legacy)
OG000 OG004	0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.035	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	13.39	2-Sided	95	6.28	20.50	Superiority or Other (legacy)
OG001 OG004	0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	20.14	2-Sided	95	8.67	31.62	Superiority or Other (legacy)
OG002 OG004	0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.088	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	9.56	2-Sided	95	-1.39	20.51	Superiority or Other (legacy)
OG003 OG004	0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.100	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	9.36	2-Sided	95	-1.73	20.45	Superiority or Other (legacy)
OG000 OG001	1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	62.54	2-Sided	95	50.93	74.15	Superiority or Other (legacy)
OG000 OG002	1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	51.66	2-Sided	95	39.50	63.82	Superiority or Other (legacy)
OG000 OG003	1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	64.68	2-Sided	95	52.92	76.43	Superiority or Other (legacy)
OG000 OG004	1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	52.03	2-Sided	95	40.43	63.63	Superiority or Other (legacy)
OG001 OG004	1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.138	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	10.66	2-Sided	95	-3.04	24.35	Superiority or Other (legacy)
OG002 OG004	1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.935	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	-0.59	2-Sided	95	-14.71	13.52	Superiority or Other (legacy)
OG003 OG004	1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.063	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	13.30	2-Sided	95	-0.57	27.17	Superiority or Other (legacy)
OG000 OG001	1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	74.68	2-Sided	95	62.82	86.53	Superiority or Other (legacy)
OG000 OG002	1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	63.18	2-Sided	95	50.42	75.95	Superiority or Other (legacy)
OG000 OG003	1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	71.39	2-Sided	95	59.21	83.57	Superiority or Other (legacy)
OG000 OG004	1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	60.50	2-Sided	95	47.89	73.11	Superiority or Other (legacy)
OG001 OG004	1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.027	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	14.43	2-Sided	95	1.97	26.89	Superiority or Other (legacy)
OG002 OG004	1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.729	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	2.35	2-Sided	95	-10.91	15.61	Superiority or Other (legacy)
OG003 OG004	1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.087	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	11.33	2-Sided	95	-1.55	24.21	Superiority or Other (legacy)
OG000 OG001	2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	75.60	2-Sided	95	62.50	88.70	Superiority or Other (legacy)
OG000 OG002	2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	67.45	2-Sided	95	53.65	81.24	Superiority or Other (legacy)
OG000 OG003	2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	74.46	2-Sided	95	61.21	87.70	Superiority or Other (legacy)
OG000 OG004	2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	64.23	2-Sided	95	50.30	78.17	Superiority or Other (legacy)
OG001 OG004	2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.052	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	11.59	2-Sided	95	0.12	23.06	Superiority or Other (legacy)
OG002 OG004	2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.652	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	2.84	2-Sided	95	-9.49	15.16	Superiority or Other (legacy)
OG003 OG004	2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.090	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	10.28	2-Sided	95	-1.47	22.03	Superiority or Other (legacy)
OG000 OG001	3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	79.93	2-Sided	95	67.41	92.46	Superiority or Other (legacy)
OG000 OG002	3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	71.65	2-Sided	95	58.25	85.05	Superiority or Other (legacy)
OG000 OG003	3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	78.92	2-Sided	95	66.29	91.56	Superiority or Other (legacy)
OG000 OG004	3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	70.56	2-Sided	95	57.04	84.07	Superiority or Other (legacy)
OG001 OG004	3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.069	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	9.61	2-Sided	95	-0.59	19.80	Superiority or Other (legacy)
OG002 OG004	3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.911	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	0.65	2-Sided	95	-10.73	12.03	Superiority or Other (legacy)
OG003 OG004	3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.127	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	8.27	2-Sided	95	-2.23	18.77	Superiority or Other (legacy)
OG000 OG001	4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	76.55	2-Sided	95	62.37	90.72	Superiority or Other (legacy)
OG000 OG002	4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	70.60	2-Sided	95	55.93	85.28	Superiority or Other (legacy)
OG000 OG003	4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	76.50	2-Sided	95	62.22	90.79	Superiority or Other (legacy)
OG000 OG004	4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	68.05	2-Sided	95	53.02	83.09	Superiority or Other (legacy)
OG001 OG004	4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.098	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	8.57	2-Sided	95	-1.47	18.61	Superiority or Other (legacy)
OG002 OG004	4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.721	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	2.01	2-Sided	95	-9.02	13.04	Superiority or Other (legacy)
OG003 OG004	4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.115	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	8.28	2-Sided	95	-1.85	18.41	Superiority or Other (legacy)
OG000 OG001	5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	77.66	2-Sided	95	63.63	91.69	Superiority or Other (legacy)
OG000 OG002	5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	71.65	2-Sided	95	57.07	86.22	Superiority or Other (legacy)
OG000 OG003	5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	76.50	2-Sided	95	62.22	90.79	Superiority or Other (legacy)
OG000 OG004	5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	69.10	2-Sided	95	54.14	84.06	Superiority or Other (legacy)
OG001 OG004	5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.086	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	8.56	2-Sided	95	-1.15	18.27	Superiority or Other (legacy)
OG002 OG004	5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.714	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	2.01	2-Sided	95	-8.76	12.77	Superiority or Other (legacy)
OG003 OG004	5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.164	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	7.21	2-Sided	95	-2.80	17.22	Superiority or Other (legacy)
OG000 OG001	6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	74.38	2-Sided	95	59.56	89.20	Superiority or Other (legacy)
OG000 OG002	6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	69.50	2-Sided	95	54.29	84.70	Superiority or Other (legacy)
OG000 OG003	6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	73.24	2-Sided	95	58.18	88.30	Superiority or Other (legacy)
OG000 OG004	6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	67.00	2-Sided	95	51.40	82.61	Superiority or Other (legacy)
OG001 OG004	6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.129	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	7.46	2-Sided	95	-2.12	17.04	Superiority or Other (legacy)
OG002 OG004	6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.712	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	1.97	2-Sided	95	-8.50	12.43	Superiority or Other (legacy)
OG003 OG004	6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.229	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	6.12	2-Sided	95	-3.76	16.00	Superiority or Other (legacy)
OG000 OG001	7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	74.38	2-Sided	95	59.56	89.20	Superiority or Other (legacy)
OG000 OG002	7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	70.54	2-Sided	95	55.45	85.64	Superiority or Other (legacy)
OG000 OG003	7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	73.24	2-Sided	95	58.18	88.30	Superiority or Other (legacy)
OG000 OG004	7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	68.05	2-Sided	95	52.53	83.57	Superiority or Other (legacy)
OG001 OG004	7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.186	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	6.38	2-Sided	95	-3.05	15.81	Superiority or Other (legacy)
OG002 OG004	7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.703	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	1.97	2-Sided	95	-8.18	12.12	Superiority or Other (legacy)
OG003 OG004	7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.312	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	5.06	2-Sided	95	-4.68	14.79	Superiority or Other (legacy)
OG000 OG001	8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	74.38	2-Sided	95	59.56	89.20	Superiority or Other (legacy)
OG000 OG002	8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	71.59	2-Sided	95	56.61	86.57	Superiority or Other (legacy)
OG000 OG003	8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	73.24	2-Sided	95	58.18	88.30	Superiority or Other (legacy)
OG000 OG004	8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	69.21	2-Sided	95	53.86	84.56	Superiority or Other (legacy)
OG001 OG004	8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.265	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	5.25	2-Sided	95	-3.92	14.41	Superiority or Other (legacy)
OG002 OG004	8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.710	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	1.85	2-Sided	95	-7.82	11.53	Superiority or Other (legacy)
OG003 OG004	8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.416	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	3.99	2-Sided	95	-5.52	13.49	Superiority or Other (legacy)
OG000 OG001	9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	74.38	2-Sided	95	59.56	89.20	Superiority or Other (legacy)
OG000 OG002	9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	71.59	2-Sided	95	56.61	86.57	Superiority or Other (legacy)
OG000 OG003	9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	73.24	2-Sided	95	58.18	88.30	Superiority or Other (legacy)
OG000 OG004	9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	69.21	2-Sided	95	53.86	84.56	Superiority or Other (legacy)
OG001 OG004	9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.265	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	5.25	2-Sided	95	-3.92	14.41	Superiority or Other (legacy)
OG002 OG004	9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.710	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	1.85	2-Sided	95	-7.82	11.53	Superiority or Other (legacy)
OG003 OG004	9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.416	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	3.99	2-Sided	95	-5.52	13.49	Superiority or Other (legacy)
OG000 OG001	10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	71.10	2-Sided	95	55.82	86.38	Superiority or Other (legacy)
OG000 OG002	10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	68.31	2-Sided	95	52.88	83.74	Superiority or Other (legacy)
OG000 OG003	10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	69.98	2-Sided	95	54.47	85.48	Superiority or Other (legacy)
OG000 OG004	10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	65.95	2-Sided	95	50.16	81.74	Superiority or Other (legacy)
OG001 OG004	10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.265	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	5.25	2-Sided	95	-3.92	14.41	Superiority or Other (legacy)
OG002 OG004	10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.710	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	1.85	2-Sided	95	-7.82	11.53	Superiority or Other (legacy)
OG003 OG004	10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.416	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	3.99	2-Sided	95	-5.52	13.49	Superiority or Other (legacy)
OG000 OG001	11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	71.10	2-Sided	95	55.82	86.38	Superiority or Other (legacy)
OG000 OG002	11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	68.31	2-Sided	95	52.88	83.74	Superiority or Other (legacy)
OG000 OG003	11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	69.98	2-Sided	95	54.47	85.48	Superiority or Other (legacy)
OG000 OG004	11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	65.95	2-Sided	95	50.16	81.74	Superiority or Other (legacy)
OG001 OG004	11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.265	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	5.25	2-Sided	95	-3.92	14.41	Superiority or Other (legacy)
OG002 OG004	11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.710	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	1.85	2-Sided	95	-7.82	11.53	Superiority or Other (legacy)
OG003 OG004	11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.416	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	3.99	2-Sided	95	-5.52	13.49	Superiority or Other (legacy)
OG000 OG001	12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	71.10	2-Sided	95	55.82	86.38	Superiority or Other (legacy)
OG000 OG002	12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	68.31	2-Sided	95	52.88	83.74	Superiority or Other (legacy)
OG000 OG003	12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	69.98	2-Sided	95	54.47	85.48	Superiority or Other (legacy)
OG000 OG004	12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	<0.001	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	65.95	2-Sided	95	50.16	81.74	Superiority or Other (legacy)
OG001 OG004	12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.265	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	5.25	2-Sided	95	-3.92	14.41	Superiority or Other (legacy)
OG002 OG004	12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.710	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	1.85	2-Sided	95	-7.82	11.53	Superiority or Other (legacy)
OG003 OG004	12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.	Cochran-Mantel-Haenszel	0.416	p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.	Difference in proportion	3.99	2-Sided	95	-5.52	13.49	Superiority or Other (legacy)

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dizziness	Cardiac disorders	MedDRA v13.0	Non-systematic Assessment	EG0003 affected30 at risk EG0019 affected90 at risk EG0026 affected93 at risk EG0037 affected89 at risk EG0047 affected92 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected30 at risk EG0010 affected90 at risk EG0022 affected93 at risk EG003
Alveolar osteitis	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected30 at risk EG0014 affected90 at risk EG0022 affected93 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG00014 affected30 at risk EG00122 affected90 at risk EG00218 affected93 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v13.0	Non-systematic Assessment	EG0007 affected30 at risk EG0018 affected90 at risk EG00211 affected93 at risk EG003
Feeling hot	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0002 affected30 at risk EG0014 affected90 at risk EG0021 affected93 at risk EG003
Hyperhidrosis	General disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected30 at risk EG0012 affected90 at risk EG0020 affected93 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected30 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Tension headache	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected30 at risk EG0014 affected90 at risk EG0021 affected93 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected30 at risk EG0010 affected90 at risk EG0020 affected93 at risk EG003
Somnolence	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected30 at risk EG0010 affected90 at risk EG0021 affected93 at risk EG003
Tremor	Nervous system disorders	MedDRA v13.0	Non-systematic Assessment	EG0001 affected30 at risk EG0011 affected90 at risk EG0022 affected93 at risk EG003
Post procedural haemorrhage	Vascular disorders	MedDRA v13.0	Non-systematic Assessment	EG0000 affected30 at risk EG0010 affected90 at risk EG0022 affected93 at risk EG003

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D000814	Aniline Compounds
D000588	Amines

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received Placebo as single oral dose caplets during the 12 hours study.	30	15	30
EG001	Ibuprofen 200 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 200 mg and acetaminophen 500 mg caplets during the 12 hours study.	90	33	90
EG002	Ibuprofen 250 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg caplets during the 12 hours study.	93	27	93
EG003	Ibuprofen 300 mg + Acetaminophen 500 mg	Participants received a single oral dose of a fixed dose combination of ibuprofen 300 mg and acetaminophen 500 mg caplets during the 12 hours study.	89	22	89
EG004	Ibuprofen 400 mg	Participants received single oral dose of ibuprofen 400 mg caplets during the 12 hours study.	92	30	92