Topical Ibuprofen for Delayed Onset Mulscle Soreness

PLACEBO-CONTROLLED, DOUBLE-BLIND EVALUATION OF THE EFFICACY AND SAFETY OF IBUPROFEN 5% TOPICAL GEL FOR THE TREATMENT OF DELAYED-ONSET MUSCLE SORENESS OF THE ELBOW FLEXOR MUSCLES

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01794923

Enrollment

205

Registered

2013-02-20

Start date

2013-06-13

Completion date

2014-03-29

Last updated

2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Delayed onset muscle soreness, ibuprofen, topical

Brief summary

The objective of this study is to compare the efficacy and safety of Ibuprofen 5% Topical Gel versus placebo administered two or three times daily for the treatment of pain associated with delayed onset muscle soreness following intense eccentric exercise of the elbow flexor muscles.

Interventions

DRUGIBU BID

10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days

DRUGPlacebo BID

10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days

DRUGIBU TID

10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days

DRUGPlacebo TID

10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Males or females, 18 to 65 years of age, who have not engaged in upper extremity fitness activities for a minimum of 3 months prior to entry in the study; subjects must be willing to refrain from use of pharmacologic or non pharmacologic treatments (ie, heat, ice, massage) and other forms of soreness relief during the study

Exclusion criteria

Use of corticosteroids or short- or long-acting non-steroidal anti-inflammatory drugs

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 0-24 Hours Post-Dose 1 (MSM 0-24 )	Baseline, 0 to 24 hours post-Dose 1 on Day 1	Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate muscle soreness on movement (MSM). Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11 point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity. Change from baseline in the time-weighted sum of MSM over 0-24 hours was derived as the MSM change from baseline multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 0 to Hour 24 (range: -96 to 240, higher score indicates better response).

Secondary

Measure	Time frame	Description
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1	Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate MSM. Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11-point scale ranging from 0 to 10, where 0=not sore' and 10=extremely sore, higher score=more severity.
Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1	Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1	Participants after sitting quietly for 3 minutes, were asked to extend the arm that was exercised earlier to stimulate MSM. Participants were asked to rate their degree of SMS, using an 11-point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity. Change from baseline in time-weighted sum of SMS over 0-24 hours (hr.), 24-48 hr., 48-72 hr. and 0-72 hr. were derived as the SMS change from baseline multiplied by time elapsed since the previous assessment and summed overall assessment from Hour 0 to Hour 24 (range: -240 to 240, higher score indicates better response), Hour 24 to Hour 48 (range: -240 to 240, higher score indicates better response); Hour 48 to Hour 72 (range: -240 to 240, higher score indicates better response); and Hour 0 to Hour 72 (range: -720 to 720, higher score indicates better response).
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1	Participants after sitting quietly for 3 minutes, were asked to extend the arm that was exercised earlier to stimulate SMS. Participants were asked to rate their degree of SMS, using an 11-point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity.
Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours	0 to 24, 24 to 48, 48 to 72 and 0 to 72 hours on Day 1	Participants were asked: Which phrase best describes the relief of muscle soreness which you are experiencing? Participant's response were recorded using a five-point scale: 0=None, 1=A little, 2=Some, 3=A lot and 4=Complete relief. Time-weighted sum of muscle soreness relief over 0-24 hours, 24-48 hours, 48-72 hours, and 0-72 hours were derived as the muscle soreness relief score multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 0 to Hour 24 (total score range: 0 \[none\] to 96 \[complete relief\], higher score indicates better response), Hour 24 to Hour 48 (range: 0 to 96, higher score indicates better response); Hour 48 to Hour 72 (range: 0 to 96, higher score indicates better response); and Hour 0 to Hour 72 (range: 0 to 288, higher score indicates better response).
Change From Baseline in Stiffness During Muscle Soreness With Movement (SMSM) Assessment at 24 Hours Post-Dose 1	Baseline, 24 hours post-Dose 1	Participants were asked to rate their SMSM, using an 11-point scale, with 0=not stiff and 10=extremely stiff, higher score indicated more severity.
Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1	Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1	Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate MSM. Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11-point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher scores=more severity. Change from baseline in the time-weighted sum of MSM over 24-48 hours, 48-72 hours and 0-72 hours were derived as the MSM change from baseline multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 24 to Hour 48 (range: -96 to 240, higher score indicates better response); Hour 48 to Hour 72 (range: -96 to 240, higher score indicates better outcome); and Hour 0 to Hour 72 (range: -288 to 720, higher score indicates better response).
Participant's Global Assessment of Medication at Day 4	Day 4	Participants were asked the following question: How would you rate this medication as a pain reliever? Participant's response was recorded using a five point scale: 1 = Very Poor, 2 = Poor, 3 = Fair, 4 = Good, 5 = Very Good, where higher score indicated better response.
Percentage of Participants Taking Rescue Medication	Baseline up to Day 4	Acetaminophen 500 milligram (mg) every 6 hours as needed was used as rescue analgesia/therapy during the course of the study.
Time to First Use of Rescue Medication	Baseline up to Day 4	Time to first us of rescue medication was defined as time (in hours) from a dose of study medication to the first use of recue medication and was censored at the time of the next dose of study medication, or at 12 hours after the final application of the study medication. Acetaminophen 500 milligram (mg) every 6 hours as needed was used as rescue analgesia/therapy during the course of the study.
Number of Doses of Rescue Medication	Baseline up to Day 4	Acetaminophen 500 milligram (mg) every 6 hours as needed was used as rescue analgesia/therapy during the course of the study.
Muscle Soreness Relief at Each Time Point	1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1	Participants were asked: Which phrase best describes the relief of muscle soreness which you are experiencing? Participant's response was recorded using a five-point scale: 0 = None, 1 = A little, 2 = Some, 3 = A lot and 4 = Complete, higher scores indicated better response/more relief.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Placebo Combined Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.	83
Ibuprofen Twice Daily Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.	60
Ibuprofen Three Times Daily Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.	62
Total	205

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	0	0	1

Baseline characteristics

Characteristic	Placebo Combined	Ibuprofen Twice Daily	Ibuprofen Three Times Daily	Total
Age, Continuous	41.1 years STANDARD_DEVIATION 14.79	44.4 years STANDARD_DEVIATION 13.19	45.5 years STANDARD_DEVIATION 13.08	43.4 years STANDARD_DEVIATION 13.91
Muscle Soreness with Movement (MSM)	7.7 units on a scale STANDARD_DEVIATION 1.21	7.6 units on a scale STANDARD_DEVIATION 1.09	7.4 units on a scale STANDARD_DEVIATION 1.11	7.6 units on a scale STANDARD_DEVIATION 1.15
Sex: Female, Male Female	55 Participants	41 Participants	41 Participants	137 Participants
Sex: Female, Male Male	28 Participants	19 Participants	21 Participants	68 Participants
Spontaneous Muscle Soreness (SMS)	7.1 units on a scale STANDARD_DEVIATION 1.16	7.1 units on a scale STANDARD_DEVIATION 1.13	7.3 units on a scale STANDARD_DEVIATION 1.16	7.2 units on a scale STANDARD_DEVIATION 1.15
Stiffness during Muscle Soreness with Movement (SMSM)	7.5 units on a scale STANDARD_DEVIATION 1.32	7.6 units on a scale STANDARD_DEVIATION 1.18	7.4 units on a scale STANDARD_DEVIATION 1.28	7.5 units on a scale STANDARD_DEVIATION 1.26

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 83	0 / 60	4 / 62
serious Total, serious adverse events	0 / 83	0 / 60	0 / 62

Outcome results

Primary

Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 0-24 Hours Post-Dose 1 (MSM 0-24 )

Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate muscle soreness on movement (MSM). Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11 point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity. Change from baseline in the time-weighted sum of MSM over 0-24 hours was derived as the MSM change from baseline multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 0 to Hour 24 (range: -96 to 240, higher score indicates better response).

Time frame: Baseline, 0 to 24 hours post-Dose 1 on Day 1

Population: Full analysis set population included all randomized participants who were dosed with the study medication and provided a baseline assessment.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo Combined	Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 0-24 Hours Post-Dose 1 (MSM 0-24 )	22.2 units on a scale	Standard Error 4.46
Ibuprofen Twice Daily	Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 0-24 Hours Post-Dose 1 (MSM 0-24 )	17.8 units on a scale	Standard Error 5.12
Ibuprofen Three Times Daily	Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 0-24 Hours Post-Dose 1 (MSM 0-24 )	29.7 units on a scale	Standard Error 5

Comparison: Analysis was performed using an analysis of variance (ANOVA) model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.p-value: 0.2ANOVA

Comparison: Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.p-value: 0.2395% CI: [-4.81, 19.92]ANOVA

Secondary

Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1

Time frame: Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1

Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	7 hours	0.7 units on a scale	Standard Error 0.19
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	5 hours	0.5 units on a scale	Standard Error 0.16
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	24 hours	1.3 units on a scale	Standard Error 0.26
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	8 hours	0.7 units on a scale	Standard Error 0.2
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	60 hours	4.2 units on a scale	Standard Error 0.3
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	12 hours	0.9 units on a scale	Standard Error 0.22
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	9 hours	0.7 units on a scale	Standard Error 0.21
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	3 hours	0.2 units on a scale	Standard Error 0.13
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	11 hours	0.8 units on a scale	Standard Error 0.21
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	10 hours	0.9 units on a scale	Standard Error 0.21
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	54 hours	3.7 units on a scale	Standard Error 0.3
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	4 hours	0.4 units on a scale	Standard Error 0.16
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	72 hours	5.2 units on a scale	Standard Error 0.29
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	48 hours	3.3 units on a scale	Standard Error 0.29
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	1 hour	-0.0 units on a scale	Standard Error 0.1
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	36 hours	2.1 units on a scale	Standard Error 0.28
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	6 hours	0.5 units on a scale	Standard Error 0.18
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	2 hours	0.1 units on a scale	Standard Error 0.11
Placebo Combined	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	30 hours	1.7 units on a scale	Standard Error 0.26
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	5 hours	0.1 units on a scale	Standard Error 0.19
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	1 hour	-0.1 units on a scale	Standard Error 0.11
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	2 hours	-0.2 units on a scale	Standard Error 0.12
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	3 hours	-0.1 units on a scale	Standard Error 0.15
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	4 hours	0.0 units on a scale	Standard Error 0.18
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	6 hours	0.2 units on a scale	Standard Error 0.21
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	7 hours	0.3 units on a scale	Standard Error 0.22
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	8 hours	0.4 units on a scale	Standard Error 0.23
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	9 hours	0.3 units on a scale	Standard Error 0.24
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	10 hours	0.5 units on a scale	Standard Error 0.25
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	11 hours	0.5 units on a scale	Standard Error 0.24
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	12 hours	0.6 units on a scale	Standard Error 0.25
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	24 hours	1.3 units on a scale	Standard Error 0.29
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	30 hours	1.7 units on a scale	Standard Error 0.3
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	36 hours	2.2 units on a scale	Standard Error 0.33
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	48 hours	3.5 units on a scale	Standard Error 0.33
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	54 hours	3.6 units on a scale	Standard Error 0.34
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	60 hours	4.2 units on a scale	Standard Error 0.34
Ibuprofen Twice Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	72 hours	5.1 units on a scale	Standard Error 0.33
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	24 hours	1.9 units on a scale	Standard Error 0.29
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	6 hours	0.5 units on a scale	Standard Error 0.21
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	2 hours	-0.0 units on a scale	Standard Error 0.12
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	30 hours	2.0 units on a scale	Standard Error 0.29
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	5 hours	0.3 units on a scale	Standard Error 0.18
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	72 hours	4.6 units on a scale	Standard Error 0.32
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	36 hours	2.3 units on a scale	Standard Error 0.32
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	4 hours	0.2 units on a scale	Standard Error 0.18
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	60 hours	3.9 units on a scale	Standard Error 0.33
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	48 hours	3.0 units on a scale	Standard Error 0.33
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	10 hours	1.1 units on a scale	Standard Error 0.24
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	9 hours	0.1 units on a scale	Standard Error 0.23
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	3 hours	0.1 units on a scale	Standard Error 0.15
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	11 hours	1.1 units on a scale	Standard Error 0.23
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	8 hours	0.7 units on a scale	Standard Error 0.22
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	1 hour	-0.2 units on a scale	Standard Error 0.11
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	12 hours	1.2 units on a scale	Standard Error 0.25
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	7 hours	0.7 units on a scale	Standard Error 0.22
Ibuprofen Three Times Daily	Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	54 hours	3.5 units on a scale	Standard Error 0.33

Comparison: 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.63ANOVA

Comparison: 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.34295% CI: [-0.39, 0.14]ANOVA

Comparison: 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.695% CI: [-0.34, 0.19]ANOVA

Comparison: 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.69195% CI: [-0.34, 0.23]ANOVA

Comparison: 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.091ANOVA

Comparison: 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.35195% CI: [-0.44, 0.16]ANOVA

Comparison: 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.02995% CI: [-0.64, -0.04]ANOVA

Comparison: 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.23895% CI: [-0.13, 0.52]ANOVA

Comparison: 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.305ANOVA

Comparison: 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.3795% CI: [-0.54, 0.2]ANOVA

Comparison: 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.1395% CI: [-0.66, 0.09]ANOVA

Comparison: 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.56195% CI: [-0.28, 0.51]ANOVA

Comparison: 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.209ANOVA

Comparison: 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.27795% CI: [-0.68, 0.19]ANOVA

Comparison: 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.08595% CI: [-0.82, 0.05]ANOVA

Comparison: 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.54695% CI: [-0.32, 0.61]ANOVA

Comparison: 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.185ANOVA

Comparison: 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.495% CI: [-0.64, 0.26]ANOVA

Comparison: 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.06795% CI: [-0.88, 0.03]ANOVA

Comparison: 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.3595% CI: [-0.25, 0.71]ANOVA

Comparison: 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.493ANOVA

Comparison: 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.92295% CI: [-0.53, 0.48]ANOVA

Comparison: 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.26595% CI: [-0.8, 0.22]ANOVA

Comparison: 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.34295% CI: [-0.28, 0.81]ANOVA

Comparison: 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.311ANOVA

Comparison: 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.86595% CI: [-0.49, 0.58]ANOVA

Comparison: 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.19395% CI: [-0.89, 0.18]ANOVA

Comparison: 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.1795% CI: [-0.17, 0.97]ANOVA

Comparison: 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.383ANOVA

Comparison: 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.80295% CI: [-0.48, 0.62]ANOVA

Comparison: 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.2695% CI: [-0.87, 0.24]ANOVA

Comparison: 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.19995% CI: [-0.21, 0.98]ANOVA

Comparison: 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.139ANOVA

Comparison: 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.44195% CI: [-0.35, 0.8]ANOVA

Comparison: 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.18395% CI: [-0.96, 0.18]ANOVA

Comparison: 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.0595% CI: [0, 1.23]ANOVA

Comparison: 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.221ANOVA

Comparison: 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.52695% CI: [-0.4, 0.79]ANOVA

Comparison: 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.23295% CI: [-0.96, 0.23]ANOVA

Comparison: 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.08995% CI: [-0.08, 1.19]ANOVA

Comparison: 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.19ANOVA

Comparison: 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.36595% CI: [-0.31, 0.85]ANOVA

Comparison: 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.29595% CI: [-0.89, 0.27]ANOVA

Comparison: 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.06995% CI: [-0.05, 1.2]ANOVA

Comparison: 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.197ANOVA

Comparison: 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.30995% CI: [-0.29, 0.92]ANOVA

Comparison: 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.35995% CI: [-0.89, 0.33]ANOVA

Comparison: 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.07295% CI: [-0.05, 1.25]ANOVA

Comparison: 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.151ANOVA

Comparison: 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.0995% CI: [-0.1, 1.32]ANOVA

Comparison: 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.88995% CI: [-0.76, 0.66]ANOVA

Comparison: 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.08895% CI: [-0.1, 1.42]ANOVA

Comparison: 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.673ANOVA

Comparison: 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.39395% CI: [-0.41, 1.04]ANOVA

Comparison: 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.88795% CI: [-0.67, 0.78]ANOVA

Comparison: 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.50795% CI: [-0.51, 1.04]ANOVA

Comparison: 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.873ANOVA

Comparison: 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.60595% CI: [-0.58, 1]ANOVA

Comparison: 26 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.8695% CI: [-0.72, 0.86]ANOVA

Comparison: 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.75195% CI: [-0.71, 0.98]ANOVA

Comparison: 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.528ANOVA

Comparison: 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.48695% CI: [-1.09, 0.52]ANOVA

Comparison: 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.6195% CI: [-0.6, 1.02]ANOVA

Comparison: 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.26195% CI: [-1.36, 0.37]ANOVA

Comparison: 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.943ANOVA

Comparison: 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.73395% CI: [-0.96, 0.68]ANOVA

Comparison: 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.90295% CI: [-0.87, 0.77]ANOVA

Comparison: 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.8495% CI: [-0.97, 0.79]ANOVA

Comparison: 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.758ANOVA

Comparison: 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.49395% CI: [-1.12, 0.54]ANOVA

Comparison: 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.97495% CI: [-0.84, 0.82]ANOVA

Comparison: 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.54395% CI: [-1.16, 0.61]ANOVA

Comparison: 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.238ANOVA

Comparison: 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.10695% CI: [-1.46, 0.14]ANOVA

Comparison: 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.81795% CI: [-0.9, 0.71]ANOVA

Comparison: 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.19795% CI: [-1.43, 0.3]ANOVA

Secondary

Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1

Participants after sitting quietly for 3 minutes, were asked to extend the arm that was exercised earlier to stimulate SMS. Participants were asked to rate their degree of SMS, using an 11-point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity.

Time frame: Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1

Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	7 hours	0.7 units on a scale	Standard Error 0.19
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	3 hours	0.2 units on a scale	Standard Error 0.13
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	72 hours	4.9 units on a scale	Standard Error 0.28
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	8 hours	0.8 units on a scale	Standard Error 0.2
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	60 hours	4.0 units on a scale	Standard Error 0.29
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	12 hours	0.9 units on a scale	Standard Error 0.22
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	9 hours	0.8 units on a scale	Standard Error 0.21
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	48 hours	3.2 units on a scale	Standard Error 0.28
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	11 hours	0.9 units on a scale	Standard Error 0.22
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	10 hours	0.9 units on a scale	Standard Error 0.21
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	4 hours	0.4 units on a scale	Standard Error 0.15
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	2 hours	0.1 units on a scale	Standard Error 0.1
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	36 hours	2.2 units on a scale	Standard Error 0.28
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	5 hours	0.4 units on a scale	Standard Error 0.17
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	1 hour	0.0 units on a scale	Standard Error 0.08
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	30 hours	1.7 units on a scale	Standard Error 0.26
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	6 hours	0.5 units on a scale	Standard Error 0.18
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	54 hours	3.7 units on a scale	Standard Error 0.29
Placebo Combined	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	24 hours	1.3 units on a scale	Standard Error 0.26
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	12 hours	0.7 units on a scale	Standard Error 0.25
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	1 hour	0.1 units on a scale	Standard Error 0.09
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	2 hours	-0.0 units on a scale	Standard Error 0.11
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	3 hours	0.1 units on a scale	Standard Error 0.15
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	4 hours	0.2 units on a scale	Standard Error 0.17
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	5 hours	0.2 units on a scale	Standard Error 0.19
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	6 hours	0.3 units on a scale	Standard Error 0.21
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	7 hours	0.4 units on a scale	Standard Error 0.22
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	8 hours	0.5 units on a scale	Standard Error 0.23
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	9 hours	0.6 units on a scale	Standard Error 0.24
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	10 hours	0.6 units on a scale	Standard Error 0.24
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	11 hours	0.6 units on a scale	Standard Error 0.25
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	24 hours	1.2 units on a scale	Standard Error 0.3
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	30 hours	1.7 units on a scale	Standard Error 0.3
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	36 hours	2.1 units on a scale	Standard Error 0.32
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	48 hours	3.4 units on a scale	Standard Error 0.32
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	54 hours	3.6 units on a scale	Standard Error 0.33
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	60 hours	4.1 units on a scale	Standard Error 0.33
Ibuprofen Twice Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	72 hours	4.9 units on a scale	Standard Error 0.32
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	60 hours	3.5 units on a scale	Standard Error 0.34
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	24 hours	1.5 units on a scale	Standard Error 31
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	5 hours	0.3 units on a scale	Standard Error 0.2
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	54 hours	3.2 units on a scale	Standard Error 0.34
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	30 hours	1.6 units on a scale	Standard Error 0.31
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	4 hours	0.1 units on a scale	Standard Error 0.18
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	1 hour	-0.1 units on a scale	Standard Error 0.1
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	36 hours	1.9 units on a scale	Standard Error 0.33
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	3 hours	-0.1 units on a scale	Standard Error 0.16
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	72 hours	4.3 units on a scale	Standard Error 0.33
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	48 hours	2.8 units on a scale	Standard Error 0.33
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	10 hours	1.0 units on a scale	Standard Error 0.25
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	9 hours	1.0 units on a scale	Standard Error 0.25
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	2 hours	-0.2 units on a scale	Standard Error 0.12
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	11 hours	1.1 units on a scale	Standard Error 0.26
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	8 hours	0.8 units on a scale	Standard Error 0.24
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	7 hours	0.7 units on a scale	Standard Error 0.23
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	12 hours	1.2 units on a scale	Standard Error 0.26
Ibuprofen Three Times Daily	Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1	6 hours	0.4 units on a scale	Standard Error 0.22

Comparison: 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.49195% CI: [-0.5, 0.24]ANOVA

Comparison: 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.219ANOVA

Comparison: 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.21495% CI: [-0.37, 0.08]ANOVA

Comparison: 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.55595% CI: [-0.16, 0.29]ANOVA

Comparison: 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.0995% CI: [-0.45, 0.03]ANOVA

Comparison: 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.161ANOVA

Comparison: 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.05695% CI: [-0.55, 0.01]ANOVA

Comparison: 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.39595% CI: [-0.4, 0.16]ANOVA

Comparison: 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.32495% CI: [-0.45, 0.15]ANOVA

Comparison: 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.246ANOVA

Comparison: 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.09495% CI: [-0.68, 0.05]ANOVA

Comparison: 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.35995% CI: [-0.58, 0.21]ANOVA

Comparison: 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.294ANOVA

Comparison: 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.13695% CI: [-0.74, 0.1]ANOVA

Comparison: 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.29395% CI: [-0.65, 0.2]ANOVA

Comparison: 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.68295% CI: [-0.55, 0.36]ANOVA

Comparison: 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.747ANOVA

Comparison: 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.59295% CI: [-0.6, 0.34]ANOVA

Comparison: 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.47395% CI: [-0.64, 0.3]ANOVA

Comparison: 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.86695% CI: [-0.46, 0.55]ANOVA

Comparison: 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.776ANOVA

Comparison: 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.76195% CI: [-0.59, 0.43]ANOVA

Comparison: 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.47795% CI: [-0.69, 0.33]ANOVA

Comparison: 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.70595% CI: [-0.44, 0.65]ANOVA

Comparison: 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.6ANOVA

Comparison: 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.93195% CI: [-0.52, 0.56]ANOVA

Comparison: 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.38195% CI: [-0.78, 0.3]ANOVA

Comparison: 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.37195% CI: [-0.32, 0.85]ANOVA

Comparison: 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.67ANOVA

Comparison: 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.94195% CI: [-0.54, 0.58]ANOVA

Comparison: 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.43795% CI: [-0.78, 0.34]ANOVA

Comparison: 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.42995% CI: [-0.36, 0.84]ANOVA

Comparison: 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.484ANOVA

Comparison: 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.50495% CI: [-0.38, 0.78]ANOVA

Comparison: 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.52895% CI: [-0.77, 0.4]ANOVA

Comparison: 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.22995% CI: [-0.24, 1.01]ANOVA

Comparison: 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.536ANOVA

Comparison: 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.72895% CI: [-0.49, 0.7]ANOVA

Comparison: 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.41495% CI: [-0.84, 0.35]ANOVA

Comparison: 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.2895% CI: [-0.29, 0.99]ANOVA

Comparison: 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.402ANOVA

Comparison: 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.51395% CI: [-0.41, 0.81]ANOVA

Comparison: 11 hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.42495% CI: [-0.86, 0.36]ANOVA

Comparison: 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.17895% CI: [-0.21, 1.1]ANOVA

Comparison: 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.442ANOVA

Comparison: 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.35795% CI: [-0.33, 0.91]ANOVA

Comparison: 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.67595% CI: [-0.75, 0.49]ANOVA

Comparison: 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.21595% CI: [-0.25, 1.09]ANOVA

Comparison: 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.643ANOVA

Comparison: 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.46695% CI: [-0.46, 0.99]ANOVA

Comparison: 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.81895% CI: [-0.81, 0.64]ANOVA

Comparison: 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.37395% CI: [-0.43, 1.13]ANOVA

Comparison: 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.984ANOVA

Comparison: 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.87495% CI: [-0.79, 0.68]ANOVA

Comparison: 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.9995% CI: [-0.73, 0.74]ANOVA

Comparison: 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.87595% CI: [-0.85, 0.73]ANOVA

Comparison: 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.841ANOVA

Comparison: 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.5895% CI: [-1.01, 0.57]ANOVA

Comparison: 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.95895% CI: [-0.81, 0.77]ANOVA

Comparison: 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.64395% CI: [-1.05, 0.65]ANOVA

Comparison: 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.299ANOVA

Comparison: 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.2395% CI: [-1.26, 0.31]ANOVA

Comparison: 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.69495% CI: [-0.63, 0.94]ANOVA

Comparison: 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.1495% CI: [-1.48, 0.21]ANOVA

Comparison: 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.503ANOVA

Comparison: 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.26295% CI: [-1.28, 0.35]ANOVA

Comparison: 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.87195% CI: [-0.88, 0.75]ANOVA

Comparison: 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.37395% CI: [-1.27, 0.48]ANOVA

Comparison: 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.413ANOVA

Comparison: 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.31795% CI: [-1.22, 0.4]ANOVA

Comparison: 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.70895% CI: [-0.66, 0.97]ANOVA

Comparison: 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.20295% CI: [-1.44, 0.31]ANOVA

Comparison: 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.19ANOVA

Comparison: 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.09495% CI: [-1.44, 0.11]ANOVA

Comparison: 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.9695% CI: [-0.8, 0.76]ANOVA

Comparison: 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.p-value: 0.13295% CI: [-1.48, 0.2]ANOVA

Secondary

Change From Baseline in Stiffness During Muscle Soreness With Movement (SMSM) Assessment at 24 Hours Post-Dose 1

Participants were asked to rate their SMSM, using an 11-point scale, with 0=not stiff and 10=extremely stiff, higher score indicated more severity.

Time frame: Baseline, 24 hours post-Dose 1

Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo Combined	Change From Baseline in Stiffness During Muscle Soreness With Movement (SMSM) Assessment at 24 Hours Post-Dose 1	1.6 units on a scale	Standard Error 0.31
Ibuprofen Twice Daily	Change From Baseline in Stiffness During Muscle Soreness With Movement (SMSM) Assessment at 24 Hours Post-Dose 1	1.7 units on a scale	Standard Error 0.37
Ibuprofen Three Times Daily	Change From Baseline in Stiffness During Muscle Soreness With Movement (SMSM) Assessment at 24 Hours Post-Dose 1	2.1 units on a scale	Standard Error 0.36

Comparison: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.p-value: 0.533ANOVA

Comparison: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.p-value: 0.26695% CI: [-0.38, 1.38]ANOVA

Comparison: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.p-value: 0.7395% CI: [-0.74, 1.05]ANOVA

Comparison: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.p-value: 0.47995% CI: [-0.61, 1.3]ANOVA

Secondary

Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1

Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate MSM. Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11-point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher scores=more severity. Change from baseline in the time-weighted sum of MSM over 24-48 hours, 48-72 hours and 0-72 hours were derived as the MSM change from baseline multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 24 to Hour 48 (range: -96 to 240, higher score indicates better response); Hour 48 to Hour 72 (range: -96 to 240, higher score indicates better outcome); and Hour 0 to Hour 72 (range: -288 to 720, higher score indicates better response).

Time frame: Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1

Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo Combined	Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1	48-72 hours	149.6 units on a scale	Standard Error 10.06
Placebo Combined	Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1	28-48 hours	78.3 units on a scale	Standard Error 9.14
Placebo Combined	Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1	0-72 hours	194.6 units on a scale	Standard Error 16.26
Ibuprofen Twice Daily	Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1	48-72 hours	150.5 units on a scale	Standard Error 11.54
Ibuprofen Twice Daily	Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1	28-48 hours	81.0 units on a scale	Standard Error 10.49
Ibuprofen Twice Daily	Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1	0-72 hours	191.9 units on a scale	Standard Error 18.66
Ibuprofen Three Times Daily	Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1	28-48 hours	85.4 units on a scale	Standard Error 10.25
Ibuprofen Three Times Daily	Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1	0-72 hours	191.4 units on a scale	Standard Error 18.22
Ibuprofen Three Times Daily	Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1	48-72 hours	135.6 units on a scale	Standard Error 11.27

Comparison: 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.86ANOVA

Comparison: 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.58495% CI: [-18.3, 32.38]ANOVA

Comparison: 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.83895% CI: [-22.77, 28.06]ANOVA

Comparison: 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.7595% CI: [-22.81, 31.61]ANOVA

Comparison: 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.533ANOVA

Comparison: 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.32695% CI: [-41.81, 13.95]ANOVA

Comparison: 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.94595% CI: [-26.98, 28.94]ANOVA

Comparison: 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.32795% CI: [-44.85, 15.03]ANOVA

Comparison: 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.988ANOVA

Comparison: 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.88795% CI: [-48.31, 41.81]ANOVA

Comparison: 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.90795% CI: [-47.88, 42.5]ANOVA

Comparison: 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.98295% CI: [-48.95, 47.83]ANOVA

Secondary

Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1

Participants after sitting quietly for 3 minutes, were asked to extend the arm that was exercised earlier to stimulate MSM. Participants were asked to rate their degree of SMS, using an 11-point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity. Change from baseline in time-weighted sum of SMS over 0-24 hours (hr.), 24-48 hr., 48-72 hr. and 0-72 hr. were derived as the SMS change from baseline multiplied by time elapsed since the previous assessment and summed overall assessment from Hour 0 to Hour 24 (range: -240 to 240, higher score indicates better response), Hour 24 to Hour 48 (range: -240 to 240, higher score indicates better response); Hour 48 to Hour 72 (range: -240 to 240, higher score indicates better response); and Hour 0 to Hour 72 (range: -720 to 720, higher score indicates better response).

Time frame: Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1

Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo Combined	Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1	0-24 hours	21.8 units on a scale	Standard Error 4.5
Placebo Combined	Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1	24-48 hours	77.3 units on a scale	Standard Error 8.95
Placebo Combined	Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1	48-72 hours	143.9 units on a scale	Standard Error 9.64
Placebo Combined	Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1	0-72 hours	188.7 units on a scale	Standard Error 15.83
Ibuprofen Twice Daily	Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1	0-72 hours	187.7 units on a scale	Standard Error 18.4
Ibuprofen Twice Daily	Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1	0-24 hours	18.7 units on a scale	Standard Error 5.23
Ibuprofen Twice Daily	Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1	48-72 hours	146.0 units on a scale	Standard Error 11.2
Ibuprofen Twice Daily	Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1	24-48 hours	78.0 units on a scale	Standard Error 10.41
Ibuprofen Three Times Daily	Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1	0-72 hours	170.8 units on a scale	Standard Error 18.89
Ibuprofen Three Times Daily	Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1	24-48 hours	73.1 units on a scale	Standard Error 10.69
Ibuprofen Three Times Daily	Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1	48-72 hours	124.9 units on a scale	Standard Error 11.5
Ibuprofen Three Times Daily	Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1	0-24 hours	24.6 units on a scale	Standard Error 5.37

Comparison: 0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.p-value: 0.63795% CI: [-15.77, 9.68]ANOVA

Comparison: 0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.40195% CI: [-7.85, 19.57]ANOVA

Comparison: 0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.p-value: 0.702ANOVA

Comparison: 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.p-value: 0.926ANOVA

Comparison: 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.p-value: 0.74395% CI: [-29.51, 21.1]ANOVA

Comparison: 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.p-value: 0.284ANOVA

Comparison: 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.p-value: 0.17195% CI: [-46.21, 8.28]ANOVA

Comparison: 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.p-value: 0.15795% CI: [-50.5, 8.23]ANOVA

Comparison: 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.p-value: 0.699ANOVA

Comparison: 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.p-value: 0.43395% CI: [-62.58, 26.9]ANOVA

Secondary

Muscle Soreness Relief at Each Time Point

Participants were asked: Which phrase best describes the relief of muscle soreness which you are experiencing? Participant's response was recorded using a five-point scale: 0 = None, 1 = A little, 2 = Some, 3 = A lot and 4 = Complete, higher scores indicated better response/more relief.

Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1

Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo Combined	Muscle Soreness Relief at Each Time Point	1 hour	0.1 units on a scale	Standard Error 0.04
Placebo Combined	Muscle Soreness Relief at Each Time Point	30 hours	1.4 units on a scale	Standard Error 0.14
Placebo Combined	Muscle Soreness Relief at Each Time Point	8 hours	0.6 units on a scale	Standard Error 0.1
Placebo Combined	Muscle Soreness Relief at Each Time Point	60 hours	2.6 units on a scale	Standard Error 0.13
Placebo Combined	Muscle Soreness Relief at Each Time Point	24 hours	1.0 units on a scale	Standard Error 0.14
Placebo Combined	Muscle Soreness Relief at Each Time Point	9 hours	0.7 units on a scale	Standard Error 0.1
Placebo Combined	Muscle Soreness Relief at Each Time Point	3 hours	0.3 units on a scale	Standard Error 0.07
Placebo Combined	Muscle Soreness Relief at Each Time Point	12 hours	0.7 units on a scale	Standard Error 0.11
Placebo Combined	Muscle Soreness Relief at Each Time Point	10 hours	0.7 units on a scale	Standard Error 0.11
Placebo Combined	Muscle Soreness Relief at Each Time Point	6 hours	0.5 units on a scale	Standard Error 0.1
Placebo Combined	Muscle Soreness Relief at Each Time Point	11 hours	0.7 units on a scale	Standard Error 0.11
Placebo Combined	Muscle Soreness Relief at Each Time Point	54 hours	2.4 units on a scale	Standard Error 0.13
Placebo Combined	Muscle Soreness Relief at Each Time Point	4 hours	0.5 units on a scale	Standard Error 0.08
Placebo Combined	Muscle Soreness Relief at Each Time Point	72 hours	2.9 units on a scale	Standard Error 0.13
Placebo Combined	Muscle Soreness Relief at Each Time Point	48 hours	2.1 units on a scale	Standard Error 0.13
Placebo Combined	Muscle Soreness Relief at Each Time Point	5 hours	0.5 units on a scale	Standard Error 0.08
Placebo Combined	Muscle Soreness Relief at Each Time Point	2 hours	0.2 units on a scale	Standard Error 0.05
Placebo Combined	Muscle Soreness Relief at Each Time Point	36 hours	1.8 units on a scale	Standard Error 0.14
Placebo Combined	Muscle Soreness Relief at Each Time Point	7 hours	0.6 units on a scale	Standard Error 0.1
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	54 hours	2.3 units on a scale	Standard Error 0.15
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	6 hours	0.5 units on a scale	Standard Error 0.11
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	1 hour	0.1 units on a scale	Standard Error 0.05
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	2 hours	0.2 units on a scale	Standard Error 0.05
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	3 hours	0.2 units on a scale	Standard Error 0.08
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	4 hours	0.4 units on a scale	Standard Error 0.1
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	5 hours	0.3 units on a scale	Standard Error 0.1
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	7 hours	0.5 units on a scale	Standard Error 0.11
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	8 hours	0.6 units on a scale	Standard Error 0.12
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	9 hours	0.6 units on a scale	Standard Error 0.12
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	10 hours	0.7 units on a scale	Standard Error 0.13
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	11 hours	0.7 units on a scale	Standard Error 0.13
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	12 hours	0.7 units on a scale	Standard Error 0.13
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	24 hours	0.9 units on a scale	Standard Error 0.16
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	30 hours	1.3 units on a scale	Standard Error 0.16
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	36 hours	1.6 units on a scale	Standard Error 0.16
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	48 hours	2.3 units on a scale	Standard Error 0.15
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	60 hours	2.5 units on a scale	Standard Error 0.15
Ibuprofen Twice Daily	Muscle Soreness Relief at Each Time Point	72 hours	3.0 units on a scale	Standard Error 0.15
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	24 hours	1.3 units on a scale	Standard Error 0.16
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	7 hours	0.7 units on a scale	Standard Error 0.11
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	72 hours	2.6 units on a scale	Standard Error 0.15
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	30 hours	1.4 units on a scale	Standard Error 0.16
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	6 hours	0.7 units on a scale	Standard Error 0.11
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	60 hours	2.4 units on a scale	Standard Error 0.15
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	36 hours	1.7 units on a scale	Standard Error 0.16
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	4 hours	0.4 units on a scale	Standard Error 0.1
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	1 hour	0.0 units on a scale	Standard Error 0.05
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	48 hours	2.0 units on a scale	Standard Error 0.15
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	3 hours	0.3 units on a scale	Standard Error 0.08
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	10 hours	1.0 units on a scale	Standard Error 0.13
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	5 hours	0.5 units on a scale	Standard Error 0.1
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	11 hours	1.0 units on a scale	Standard Error 0.13
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	9 hours	0.9 units on a scale	Standard Error 0.12
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	54 hours	2.2 units on a scale	Standard Error 0.15
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	12 hours	1.0 units on a scale	Standard Error 0.13
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	8 hours	0.7 units on a scale	Standard Error 0.12
Ibuprofen Three Times Daily	Muscle Soreness Relief at Each Time Point	2 hours	0.2 units on a scale	Standard Error 0.05

Comparison: 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.189ANOVA

Comparison: 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.38995% CI: [-0.17, 0.07]ANOVA

Comparison: 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.27395% CI: [-0.05, 0.19]ANOVA

Comparison: 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.06995% CI: [-0.25, 0.01]ANOVA

Comparison: 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.716ANOVA

Comparison: 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.73595% CI: [-0.15, 0.11]ANOVA

Comparison: 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.41495% CI: [-0.19, 0.08]ANOVA

Comparison: 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.65295% CI: [-0.11, 0.17]ANOVA

Comparison: 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.622ANOVA

Comparison: 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.8395% CI: [-0.17, 0.21]ANOVA

Comparison: 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.44295% CI: [-0.26, 0.11]ANOVA

Comparison: 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.35895% CI: [-0.11, 0.29]ANOVA

Comparison: 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.714ANOVA

Comparison: 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.68395% CI: [-0.29, 0.19]ANOVA

Comparison: 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.41395% CI: [-0.34, 0.14]ANOVA

Comparison: 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.69995% CI: [-0.21, 0.31]ANOVA

Comparison: 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.244ANOVA

Comparison: 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.83395% CI: [-0.21, 0.26]ANOVA

Comparison: 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.15695% CI: [-0.41, 0.07]ANOVA

Comparison: 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.12895% CI: [-0.06, 0.46]ANOVA

Comparison: 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.359ANOVA

Comparison: 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.27895% CI: [-0.12, 0.43]ANOVA

Comparison: 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.69995% CI: [-0.33, 0.22]ANOVA

Comparison: 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.17295% CI: [-0.09, 0.5]ANOVA

Comparison: 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.515ANOVA

Comparison: 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.52795% CI: [-0.19, 0.37]ANOVA

Comparison: 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.54595% CI: [-0.37, 0.19]ANOVA

Comparison: 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.2595% CI: [-0.12, 0.47]ANOVA

Comparison: 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.568ANOVA

Comparison: 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.38195% CI: [-0.16, 0.41]ANOVA

Comparison: 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.86395% CI: [-0.31, 0.26]ANOVA

Comparison: 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.3395% CI: [-0.16, 0.46]ANOVA

Comparison: 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.167ANOVA

Comparison: 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.16595% CI: [-0.09, 0.5]ANOVA

Comparison: 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.56495% CI: [-0.39, 0.21]ANOVA

Comparison: 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.06895% CI: [-0.02, 0.62]ANOVA

Comparison: 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.131ANOVA

Comparison: 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.11995% CI: [-0.06, 0.56]ANOVA

Comparison: 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.61695% CI: [-0.39, 0.23]ANOVA

Comparison: 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.05695% CI: [-0.01, 0.66]ANOVA

Comparison: 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.255ANOVA

Comparison: 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.14495% CI: [-0.08, 0.57]ANOVA

Comparison: 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.93595% CI: [-0.34, 0.31]ANOVA

Comparison: 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.15395% CI: [-0.1, 0.61]ANOVA

Comparison: 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.128ANOVA

Comparison: 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.06795% CI: [-0.02, 0.63]ANOVA

Comparison: 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.99995% CI: [-0.33, 0.33]ANOVA

Comparison: 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.08895% CI: [-0.05, 0.66]ANOVA

Comparison: 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.195ANOVA

Comparison: 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.17595% CI: [-0.12, 0.67]ANOVA

Comparison: 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.6195% CI: [-0.5, 0.3]ANOVA

Comparison: 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.08395% CI: [-0.05, 0.81]ANOVA

Comparison: 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.884ANOVA

Comparison: 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.83395% CI: [-0.43, 0.35]ANOVA

Comparison: 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.6295% CI: [-0.49, 0.29]ANOVA

Comparison: 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.78895% CI: [-0.36, 0.48]ANOVA

Comparison: 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.755ANOVA

Comparison: 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.78795% CI: [-0.45, 0.34]ANOVA

Comparison: 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.45595% CI: [-0.56, 0.25]ANOVA

Comparison: 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.65495% CI: [-0.33, 0.53]ANOVA

Comparison: 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.37ANOVA

Comparison: 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.47295% CI: [-0.51, 0.24]ANOVA

Comparison: 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.42795% CI: [-0.23, 0.53]ANOVA

Comparison: 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.15995% CI: [-0.69, 0.11]ANOVA

Comparison: 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.48ANOVA

Comparison: 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.23895% CI: [-0.59, 0.15]ANOVA

Comparison: 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.79495% CI: [-0.42, 0.32]ANOVA

Comparison: 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.39595% CI: [-0.57, 0.23]ANOVA

Comparison: 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.4ANOVA

Comparison: 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.17695% CI: [-0.61, 0.11]ANOVA

Comparison: 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.57395% CI: [-0.47, 0.26]ANOVA

Comparison: 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.46695% CI: [-0.53, 0.24]ANOVA

Comparison: 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.092ANOVA

Comparison: 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.08695% CI: [-0.67, 0.04]ANOVA

Comparison: 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.61695% CI: [-0.27, 0.45]ANOVA

Comparison: 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.0495% CI: [-0.79, -0.02]ANOVA

Secondary

Number of Doses of Rescue Medication

Acetaminophen 500 milligram (mg) every 6 hours as needed was used as rescue analgesia/therapy during the course of the study.

Time frame: Baseline up to Day 4

Population: Due to change in conduct of study no rescue medication was use, therefore data for this outcome measure was not collected and analyzed.

Secondary

Participant's Global Assessment of Medication at Day 4

Participants were asked the following question: How would you rate this medication as a pain reliever? Participant's response was recorded using a five point scale: 1 = Very Poor, 2 = Poor, 3 = Fair, 4 = Good, 5 = Very Good, where higher score indicated better response.

Time frame: Day 4

Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.

Arm	Measure	Value (MEAN)	Dispersion
Placebo Combined	Participant's Global Assessment of Medication at Day 4	2.3 units on a scale	Standard Deviation 1.08
Ibuprofen Twice Daily	Participant's Global Assessment of Medication at Day 4	2.4 units on a scale	Standard Deviation 1.15
Ibuprofen Three Times Daily	Participant's Global Assessment of Medication at Day 4	2.2 units on a scale	Standard Deviation 1.19

Comparison: Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.p-value: 0.751Cochran-Mantel-Haenszel

Comparison: Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.p-value: 0.69695% CI: [-0.28, 0.2]Cochran-Mantel-Haenszel

Secondary

Percentage of Participants Taking Rescue Medication

Acetaminophen 500 milligram (mg) every 6 hours as needed was used as rescue analgesia/therapy during the course of the study.

Time frame: Baseline up to Day 4

Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.

Arm	Measure	Value (NUMBER)
Placebo Combined	Percentage of Participants Taking Rescue Medication	0 percentage of participants
Ibuprofen Twice Daily	Percentage of Participants Taking Rescue Medication	0 percentage of participants
Ibuprofen Three Times Daily	Percentage of Participants Taking Rescue Medication	0 percentage of participants

Secondary

Time to First Use of Rescue Medication

Time to first us of rescue medication was defined as time (in hours) from a dose of study medication to the first use of recue medication and was censored at the time of the next dose of study medication, or at 12 hours after the final application of the study medication. Acetaminophen 500 milligram (mg) every 6 hours as needed was used as rescue analgesia/therapy during the course of the study.

Time frame: Baseline up to Day 4

Population: Due to change in conduct of study no rescue medication was use, therefore data for this outcome measure was not collected and analyzed.

Secondary

Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours

Participants were asked: Which phrase best describes the relief of muscle soreness which you are experiencing? Participant's response were recorded using a five-point scale: 0=None, 1=A little, 2=Some, 3=A lot and 4=Complete relief. Time-weighted sum of muscle soreness relief over 0-24 hours, 24-48 hours, 48-72 hours, and 0-72 hours were derived as the muscle soreness relief score multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 0 to Hour 24 (total score range: 0 \[none\] to 96 \[complete relief\], higher score indicates better response), Hour 24 to Hour 48 (range: 0 to 96, higher score indicates better response); Hour 48 to Hour 72 (range: 0 to 96, higher score indicates better response); and Hour 0 to Hour 72 (range: 0 to 288, higher score indicates better response).

Time frame: 0 to 24, 24 to 48, 48 to 72 and 0 to 72 hours on Day 1

Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo Combined	Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours	0-24 hours	18.8 units on a scale	Standard Error 2.26
Placebo Combined	Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours	48-72 hours	90.5 units on a scale	Standard Error 4.19
Placebo Combined	Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours	24-48 hours	57.3 units on a scale	Standard Error 4.31
Placebo Combined	Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours	0-72 hours	128.6 units on a scale	Standard Error 7.18
Ibuprofen Twice Daily	Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours	0-24 hours	16.8 units on a scale	Standard Error 2.64
Ibuprofen Twice Daily	Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours	0-72 hours	127.2 units on a scale	Standard Error 8.39
Ibuprofen Twice Daily	Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours	48-72 hours	92.5 units on a scale	Standard Error 4.89
Ibuprofen Twice Daily	Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours	24-48 hours	56.4 units on a scale	Standard Error 5.04
Ibuprofen Three Times Daily	Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours	0-72 hours	124.4 units on a scale	Standard Error 8.29
Ibuprofen Three Times Daily	Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours	48-72 hours	82.3 units on a scale	Standard Error 4.83
Ibuprofen Three Times Daily	Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours	24-48 hours	58.4 units on a scale	Standard Error 4.98
Ibuprofen Three Times Daily	Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours	0-24 hours	23.4 units on a scale	Standard Error 2.61

Comparison: 0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.163ANOVA

Comparison: 0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.16295% CI: [-1.86, 11.02]ANOVA

Comparison: 0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.55995% CI: [-8.42, 4.57]ANOVA

Comparison: 0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.06695% CI: [-0.44, 13.45]ANOVA

Comparison: 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.957ANOVA

Comparison: 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.86495% CI: [-11.2, 13.33]ANOVA

Comparison: 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.88395% CI: [-13.3, 11.45]ANOVA

Comparison: 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.76795% CI: [-11.24, 15.22]ANOVA

Comparison: 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.243ANOVA

Comparison: 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.17695% CI: [-20.12, 3.7]ANOVA

Comparison: 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.74195% CI: [-10, 14.03]ANOVA

Comparison: 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.11895% CI: [-23.07, 2.62]ANOVA

Comparison: 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.92ANOVA

Comparison: 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.68595% CI: [-24.64, 16.23]ANOVA

Comparison: 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.89295% CI: [-22.04, 19.19]ANOVA

Comparison: 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.p-value: 0.80495% CI: [-24.82, 19.25]ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Topical Ibuprofen for Delayed Onset Mulscle Soreness

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 0-24 Hours Post-Dose 1 (MSM 0-24 )

Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1

Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1

Change From Baseline in Stiffness During Muscle Soreness With Movement (SMSM) Assessment at 24 Hours Post-Dose 1

Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1

Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1

Muscle Soreness Relief at Each Time Point

Number of Doses of Rescue Medication

Participant's Global Assessment of Medication at Day 4

Percentage of Participants Taking Rescue Medication

Time to First Use of Rescue Medication

Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours