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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen 5% topical gel BID | Experimental | IBU BID (Treatment A) |
|
| Placebo topical gel BID | Placebo Comparator | Placebo BID (Treatment B) |
|
| Ibuprofen 5% topical gel TID | Experimental | IBU TID (Treatment C) |
|
| Placebo topical gel TID | Placebo Comparator | Placebo TID (Treatment D) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBU BID | Drug | 10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 0 to 24 hours post-Dose 1 on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Applied Pharmaceutical Research | Philadelphia | Pennsylvania | 19145 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Ibuprofen Twice Daily | Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3. |
| FG002 | Ibuprofen Three Times Daily | Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Ibuprofen Twice Daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline 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). | Full analysis set population included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 0 to 24 hours post-Dose 1 on Day 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo BID | Drug | 10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days |
|
| IBU TID | Drug | 10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days |
|
| Placebo TID | Drug | 10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 days |
|
| Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1 |
| 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 | 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. | 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 |
| 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). | Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 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 | 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. | 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 |
| 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). | 0 to 24, 24 to 48, 48 to 72 and 0 to 72 hours on Day 1 |
| 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. | Baseline, 24 hours post-Dose 1 |
| 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. | 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 |
| 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. | Day 4 |
| 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. | Baseline up to Day 4 |
| 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. | Baseline up to Day 4 |
| 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. | Baseline up to Day 4 |
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3. |
| BG002 | Ibuprofen Three Times Daily | Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Muscle Soreness with Movement (MSM) | Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate muscle soreness on movement. Upon completion of preacher curl, participants were asked to rate their degree of muscle soreness with movement, using an 11-point scale ranging from 0 to 10, where 0 signifies 'not sore' and 10 signifies 'extremely sore', higher score= more severity. | Mean | Standard Deviation | units on a scale |
|
| Stiffness during Muscle Soreness with Movement (SMSM) | Participants were asked to rate their stiffness during muscle soreness with movement, using an 11-point scale, with 0 = 'not stiff' and 10 = 'extremely stiff', higher score= more severity. | Mean | Standard Deviation | units on a scale |
|
| Spontaneous Muscle Soreness (SMS) | Participants after sitting quietly for 3 minutes, were asked to extend the arm which was exercised earlier to stimulate muscle soreness on movement. Participants were asked to rate their degree of spontaneous muscle soreness, using an 11-point scale ranging from 0 to 10, where 0 signifies 'not sore' and 10 signifies 'extremely sore', higher score=more severity. | Mean | Standard Deviation | units on a scale |
|
| 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. |
| OG001 | Ibuprofen Twice Daily | Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3. |
| OG002 | Ibuprofen Three Times Daily | Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3. |
|
|
|
| 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). | Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1 |
|
|
|
|
| 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 | 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. | Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1 |
|
|
|
|
| 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). | Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1 |
|
|
|
|
| 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. | Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1 |
|
|
|
|
| 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). | Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | 0 to 24, 24 to 48, 48 to 72 and 0 to 72 hours on Day 1 |
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| 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. | Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 24 hours post-Dose 1 |
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| 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. | Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | 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 |
|
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| 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. | Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | Day 4 |
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| 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. | Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Number | percentage of participants | Baseline up to Day 4 |
|
|
|
| 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. | Due to change in conduct of study no rescue medication was use, therefore data for this outcome measure was not collected and analyzed. | Posted | Baseline up to Day 4 |
|
|
| 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. | Due to change in conduct of study no rescue medication was use, therefore data for this outcome measure was not collected and analyzed. | Posted | Baseline up to Day 4 |
|
|
| 0 |
| 83 |
| 0 |
| 83 |
| EG001 | Ibuprofen Twice Daily | Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3. | 0 | 60 | 0 | 60 |
| EG002 | Ibuprofen Three Times Daily | Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3. | 0 | 62 | 4 | 62 |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
|
| 0-72 hours |
|
| ANOVA |
| 0.584 |
| LS Mean Difference |
| 7.0 |
| 2-Sided |
| 95 |
| -18.30 |
| 32.38 |
| Superiority or Other (legacy) |
| 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.838 | LS Mean Difference | 2.6 | 2-Sided | 95 | -22.77 | 28.06 | Superiority or Other (legacy) |
| 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.750 | LS Mean Difference | 4.4 | 2-Sided | 95 | -22.81 | 31.61 | Superiority or Other (legacy) |
| 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.533 | 2-Sided | Superiority or Other (legacy) |
| 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.326 | LS Mean Difference | -13.9 | 2-Sided | 95 | -41.81 | 13.95 | Superiority or Other (legacy) |
| 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.945 | LS Mean Difference | 1.0 | 2-Sided | 95 | -26.98 | 28.94 | Superiority or Other (legacy) |
| 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.327 | LS Mean Difference | -14.9 | 2-Sided | 95 | -44.85 | 15.03 | Superiority or Other (legacy) |
| 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.988 | 2-Sided | Superiority or Other (legacy) |
| 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.887 | LS Mean Difference | -3.2 | 2-Sided | 95 | -48.31 | 41.81 | Superiority or Other (legacy) |
| 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.907 | LS Mean Difference | -2.7 | 2-Sided | 95 | -47.88 | 42.50 | Superiority or Other (legacy) |
| 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.982 | LS Mean Difference | -0.6 | 2-Sided | 95 | -48.95 | 47.83 | Superiority or Other (legacy) |
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| 3 hours |
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| 4 hours |
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| 5 hours |
|
| 6 hours |
|
| 7 hours |
|
| 8 hours |
|
| 9 hours |
|
| 10 hours |
|
| 11 hours |
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| 12 hours |
|
| 24 hours |
|
| 30 hours |
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| 36 hours |
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| 48 hours |
|
| 54 hours |
|
| 60 hours |
|
| 72 hours |
|
| ANOVA |
| 0.342 |
| LS Mean Difference |
| -0.1 |
| 2-Sided |
| 95 |
| -0.39 |
| 0.14 |
| Superiority or Other (legacy) |
| 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.600 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.34 | 0.19 | Superiority or Other (legacy) |
| 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.691 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.34 | 0.23 | Superiority or Other (legacy) |
| 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.091 | 2-Sided | Superiority or Other (legacy) |
| 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.351 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.44 | 0.16 | Superiority or Other (legacy) |
| 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.029 | LS Mean Difference | -0.3 | 2-Sided | 95 | -0.64 | -0.04 | Superiority or Other (legacy) |
| 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.238 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.13 | 0.52 | Superiority or Other (legacy) |
| 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.305 | 2-Sided | Superiority or Other (legacy) |
| 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.370 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.54 | 0.20 | Superiority or Other (legacy) |
| 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.130 | LS Mean Difference | -0.3 | 2-Sided | 95 | -0.66 | 0.09 | Superiority or Other (legacy) |
| 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.561 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.28 | 0.51 | Superiority or Other (legacy) |
| 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.209 | 2-Sided | Superiority or Other (legacy) |
| 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.277 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.68 | 0.19 | Superiority or Other (legacy) |
| 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.085 | LS Mean Difference | -0.4 | 2-Sided | 95 | -0.82 | 0.05 | Superiority or Other (legacy) |
| 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.546 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.32 | 0.61 | Superiority or Other (legacy) |
| 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.185 | 2-Sided | Superiority or Other (legacy) |
| 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.400 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.64 | 0.26 | Superiority or Other (legacy) |
| 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.067 | LS Mean Difference | -0.4 | 2-Sided | 95 | -0.88 | 0.03 | Superiority or Other (legacy) |
| 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.350 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.25 | 0.71 | Superiority or Other (legacy) |
| 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.493 | 2-Sided | Superiority or Other (legacy) |
| 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.922 | LS Mean Difference | -0.0 | 2-Sided | 95 | -0.53 | 0.48 | Superiority or Other (legacy) |
| 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.265 | LS Mean Difference | -0.3 | 2-Sided | 95 | -0.80 | 0.22 | Superiority or Other (legacy) |
| 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.342 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.28 | 0.81 | Superiority or Other (legacy) |
| 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.311 | 2-Sided | Superiority or Other (legacy) |
| 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.865 | LS Mean Difference | 0.0 | 2-Sided | 95 | -0.49 | 0.58 | Superiority or Other (legacy) |
| 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.193 | LS Mean Difference | -0.4 | 2-Sided | 95 | -0.89 | 0.18 | Superiority or Other (legacy) |
| 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.170 | LS Mean Difference | 0.4 | 2-Sided | 95 | -0.17 | 0.97 | Superiority or Other (legacy) |
| 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.383 | 2-Sided | Superiority or Other (legacy) |
| 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.802 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.48 | 0.62 | Superiority or Other (legacy) |
| 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.260 | LS Mean Difference | -0.3 | 2-Sided | 95 | -0.87 | 0.24 | Superiority or Other (legacy) |
| 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.199 | LS Mean Difference | 0.4 | 2-Sided | 95 | -0.21 | 0.98 | Superiority or Other (legacy) |
| 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.139 | 2-Sided | Superiority or Other (legacy) |
| 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.441 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.35 | 0.80 | Superiority or Other (legacy) |
| 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.183 | LS Mean Difference | -0.4 | 2-Sided | 95 | -0.96 | 0.18 | Superiority or Other (legacy) |
| 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.050 | LS Mean Difference | 0.6 | 2-Sided | 95 | -0.00 | 1.23 | Superiority or Other (legacy) |
| 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.221 | 2-Sided | Superiority or Other (legacy) |
| 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.526 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.40 | 0.79 | Superiority or Other (legacy) |
| 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.232 | LS mean Difference | -0.4 | 2-Sided | 95 | -0.96 | 0.23 | Superiority or Other (legacy) |
| 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.089 | LS Mean Difference | 0.6 | 2-Sided | 95 | -0.08 | 1.19 | Superiority or Other (legacy) |
| 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.190 | 2-Sided | Superiority or Other (legacy) |
| 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.365 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.31 | 0.85 | Superiority or Other (legacy) |
| 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.295 | LS Mean Difference | -0.3 | 2-Sided | 95 | -0.89 | 0.27 | Superiority or Other (legacy) |
| 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.069 | LS Mean Difference | 0.6 | 2-Sided | 95 | -0.05 | 1.20 | Superiority or Other (legacy) |
| 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.197 | 2-Sided | Superiority or Other (legacy) |
| 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.309 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.29 | 0.92 | Superiority or Other (legacy) |
| 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.359 | LS Mean Difference | -0.3 | 2-Sided | 95 | -0.89 | 0.33 | Superiority or Other (legacy) |
| 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.072 | LS Mean Difference | 0.6 | 2-Sided | 95 | -0.05 | 1.25 | Superiority or Other (legacy) |
| 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.151 | 2-Sided | Superiority or Other (legacy) |
| 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.090 | LS Mean Difference | 0.6 | 2-Sided | 95 | -0.10 | 1.32 | Superiority or Other (legacy) |
| 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.889 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.76 | 0.66 | Superiority or Other (legacy) |
| 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.088 | LS Mean Difference | 0.7 | 2-Sided | 95 | -0.10 | 1.42 | Superiority or Other (legacy) |
| 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.673 | 2-Sided | Superiority or Other (legacy) |
| 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.393 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.41 | 1.04 | Superiority or Other (legacy) |
| 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.887 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.67 | 0.78 | Superiority or Other (legacy) |
| 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.507 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.51 | 1.04 | Superiority or Other (legacy) |
| 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.873 | 2-Sided | Superiority or Other (legacy) |
| 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.605 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.58 | 1.00 | Superiority or Other (legacy) |
| 26 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.860 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.72 | 0.86 | Superiority or Other (legacy) |
| 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.751 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.71 | 0.98 | Superiority or Other (legacy) |
| 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.528 | 2-Sided | Superiority or Other (legacy) |
| 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.486 | LS Mean Difference | -0.3 | 2-Sided | 95 | -1.09 | 0.52 | Superiority or Other (legacy) |
| 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.610 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.60 | 1.02 | Superiority or Other (legacy) |
| 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.261 | LS Mean Difference | -0.5 | 2-Sided | 95 | -1.36 | 0.37 | Superiority or Other (legacy) |
| 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.943 | 2-Sided | Superiority or Other (legacy) |
| 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.733 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.96 | 0.68 | Superiority or Other (legacy) |
| 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.902 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.87 | 0.77 | Superiority or Other (legacy) |
| 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.840 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.97 | 0.79 | Superiority or Other (legacy) |
| 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.758 | 2-Sided | Superiority or Other (legacy) |
| 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.493 | LS Mean Difference | -0.3 | 2-Sided | 95 | -1.12 | 0.54 | Superiority or Other (legacy) |
| 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.974 | LS Mean Difference | -0.0 | 2-Sided | 95 | -0.84 | 0.82 | Superiority or Other (legacy) |
| 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.543 | LS Mean Difference | -0.3 | 2-Sided | 95 | -1.16 | 0.61 | Superiority or Other (legacy) |
| 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.238 | 2-Sided | Superiority or Other (legacy) |
| 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.106 | LS Mean Difference | -0.7 | 2-Sided | 95 | -1.46 | 0.14 | Superiority or Other (legacy) |
| 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.817 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.90 | 0.71 | Superiority or Other (legacy) |
| 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.197 | LS Mean Difference | -0.6 | 2-Sided | 95 | -1.43 | 0.30 | Superiority or Other (legacy) |
|
| 48-72 hours |
|
| 0-72 hours |
|
| ANOVA |
| 0.664 |
| LS Mean Difference |
| 2.8 |
| 2-Sided |
| 95 |
| -9.91 |
| 15.53 |
| Superiority or Other (legacy) |
| 0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms. | ANOVA | 0.637 | LS Mean Difference | -3.0 | 2-Sided | 95 | -15.77 | 9.68 | Superiority or Other (legacy) |
| 0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.401 | LS Mean Difference | 5.9 | 2-Sided | 95 | -7.85 | 19.57 | Superiority or Other (legacy) |
| 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms. | ANOVA | 0.926 | 2-Sided | Superiority or Other (legacy) |
| 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms. | ANOVA | 0.743 | LS Mean Difference | -4.2 | 2-Sided | 95 | -29.51 | 21.10 | Superiority or Other (legacy) |
| 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms. | ANOVA | 0.952 | LS Mean Difference | 0.8 | 2-Sided | 95 | -24.55 | 26.08 | Superiority or Other (legacy) |
| 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms. | ANOVA | 0.719 | LS Mean Difference | -5.0 | 2-Sided | 95 | -32.25 | 22.30 | Superiority or Other (legacy) |
| 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms. | ANOVA | 0.284 | 2-Sided | Superiority or Other (legacy) |
| 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms. | ANOVA | 0.171 | LS Mean Difference | -19.0 | 2-Sided | 95 | -46.21 | 8.28 | Superiority or Other (legacy) |
| 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms. | ANOVA | 0.875 | LS Mean Difference | 2.2 | 2-Sided | 95 | -25.08 | 29.42 | Superiority or Other (legacy) |
| 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms. | ANOVA | 0.157 | LS Mean Difference | -21.1 | 2-Sided | 95 | -50.50 | 8.23 | Superiority or Other (legacy) |
| 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms. | ANOVA | 0.699 | 2-Sided | Superiority or Other (legacy) |
| 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms. | ANOVA | 0.433 | LS Mean Difference | -17.8 | 2-Sided | 95 | -62.58 | 26.90 | Superiority or Other (legacy) |
| 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms. | ANOVA | 0.966 | LS Mean Difference | -1.0 | 2-Sided | 95 | -45.73 | 43.78 | Superiority or Other (legacy) |
| 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms. | ANOVA | 0.491 | LS Mean Difference | -16.9 | 2-Sided | 95 | -65.08 | 31.36 | Superiority or Other (legacy) |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 7 hours |
|
| 8 hours |
|
| 9 hours |
|
| 10 hours |
|
| 11 hours |
|
| 12 hours |
|
| 24 hours |
|
| 30 hours |
|
| 36 hours |
|
| 48 hours |
|
| 54 hours |
|
| 60 hours |
|
| 72 hours |
|
| ANOVA |
| 0.214 |
| LS Mean Difference |
| -0.1 |
| 2-Sided |
| 95 |
| -0.37 |
| 0.08 |
| Superiority or Other (legacy) |
| 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.555 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.16 | 0.29 | Superiority or Other (legacy) |
| 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.090 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.45 | 0.03 | Superiority or Other (legacy) |
| 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.161 | 2-Sided | Superiority or Other (legacy) |
| 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.056 | LS Mean Difference | -0.3 | 2-Sided | 95 | -0.55 | 0.01 | Superiority or Other (legacy) |
| 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.395 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.40 | 0.16 | Superiority or Other (legacy) |
| 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.324 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.45 | 0.15 | Superiority or Other (legacy) |
| 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.246 | 2-Sided | Superiority or Other (legacy) |
| 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.094 | LS Mean Difference | -0.3 | 2-Sided | 95 | -0.68 | 0.05 | Superiority or Other (legacy) |
| 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.491 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.50 | 0.24 | Superiority or Other (legacy) |
| 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.359 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.58 | 0.21 | Superiority or Other (legacy) |
| 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.294 | 2-Sided | Superiority or Other (legacy) |
| 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.136 | LS Mean Difference | -0.3 | 2-Sided | 95 | -0.74 | 0.10 | Superiority or Other (legacy) |
| 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.293 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.65 | 0.20 | Superiority or Other (legacy) |
| 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.682 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.55 | 0.36 | Superiority or Other (legacy) |
| 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.747 | 2-Sided | Superiority or Other (legacy) |
| 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.592 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.60 | 0.34 | Superiority or Other (legacy) |
| 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.473 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.64 | 0.30 | Superiority or Other (legacy) |
| 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.866 | LS Mean Difference | 0.0 | 2-Sided | 95 | -0.46 | 0.55 | Superiority or Other (legacy) |
| 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.776 | 2-Sided | Superiority or Other (legacy) |
| 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.761 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.59 | 0.43 | Superiority or Other (legacy) |
| 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.477 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.69 | 0.33 | Superiority or Other (legacy) |
| 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.705 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.44 | 0.65 | Superiority or Other (legacy) |
| 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.600 | 2-Sided | Superiority or Other (legacy) |
| 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.931 | LS Mean Difference | 0.0 | 2-Sided | 95 | -0.52 | 0.56 | Superiority or Other (legacy) |
| 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.381 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.78 | 0.30 | Superiority or Other (legacy) |
| 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.371 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.32 | 0.85 | Superiority or Other (legacy) |
| 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.670 | 2-Sided | Superiority or Other (legacy) |
| 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.941 | LS Mean Difference | 0.0 | 2-Sided | 95 | -0.54 | 0.58 | Superiority or Other (legacy) |
| 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.437 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.78 | 0.34 | Superiority or Other (legacy) |
| 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.429 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.36 | 0.84 | Superiority or Other (legacy) |
| 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.484 | 2-Sided | Superiority or Other (legacy) |
| 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.504 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.38 | 0.78 | Superiority or Other (legacy) |
| 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.528 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.77 | 0.40 | Superiority or Other (legacy) |
| 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.229 | LS Mean Difference | 0.4 | 2-Sided | 95 | -0.24 | 1.01 | Superiority or Other (legacy) |
| 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.536 | 2-Sided | Superiority or Other (legacy) |
| 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.728 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.49 | 0.70 | Superiority or Other (legacy) |
| 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.414 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.84 | 0.35 | Superiority or Other (legacy) |
| 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.280 | LS Mean Difference | 0.4 | 2-Sided | 95 | -0.29 | 0.99 | Superiority or Other (legacy) |
| 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.402 | 2-Sided | Superiority or Other (legacy) |
| 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.513 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.41 | 0.81 | Superiority or Other (legacy) |
| 11 hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.424 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.86 | 0.36 | Superiority or Other (legacy) |
| 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.178 | LS Mean Difference | 0.4 | 2-Sided | 95 | -0.21 | 1.10 | Superiority or Other (legacy) |
| 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.442 | 2-Sided | Superiority or Other (legacy) |
| 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.357 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.33 | 0.91 | Superiority or Other (legacy) |
| 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.675 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.75 | 0.49 | Superiority or Other (legacy) |
| 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.215 | LS Mean Difference | 0.4 | 2-Sided | 95 | -0.25 | 1.09 | Superiority or Other (legacy) |
| 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.643 | 2-Sided | Superiority or Other (legacy) |
| 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.466 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.46 | 0.99 | Superiority or Other (legacy) |
| 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.818 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.81 | 0.64 | Superiority or Other (legacy) |
| 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.373 | LS Mean Difference | 0.4 | 2-Sided | 95 | -0.43 | 1.13 | Superiority or Other (legacy) |
| 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.984 | 2-Sided | Superiority or Other (legacy) |
| 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.874 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.79 | 0.68 | Superiority or Other (legacy) |
| 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.990 | LS Mean Difference | 0.0 | 2-Sided | 95 | -0.73 | 0.74 | Superiority or Other (legacy) |
| 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.875 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.85 | 0.73 | Superiority or Other (legacy) |
| 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.841 | 2-Sided | Superiority or Other (legacy) |
| 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.580 | LS Mean Difference | -0.2 | 2-Sided | 95 | -1.01 | 0.57 | Superiority or Other (legacy) |
| 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.958 | LS Mean Difference | -0.0 | 2-Sided | 95 | -0.81 | 0.77 | Superiority or Other (legacy) |
| 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.643 | LS Mean Difference | -0.2 | 2-Sided | 95 | -1.05 | 0.65 | Superiority or Other (legacy) |
| 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.299 | 2-Sided | Superiority or Other (legacy) |
| 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.230 | LS mean Difference | -0.5 | 2-Sided | 95 | -1.26 | 0.31 | Superiority or Other (legacy) |
| 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.694 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.63 | 0.94 | Superiority or Other (legacy) |
| 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.140 | LS Mean Difference | -0.6 | 2-Sided | 95 | -1.48 | 0.21 | Superiority or Other (legacy) |
| 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.503 | 2-Sided | Superiority or Other (legacy) |
| 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.262 | LS Mean Difference | -0.5 | 2-Sided | 95 | -1.28 | 0.35 | Superiority or Other (legacy) |
| 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.871 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.88 | 0.75 | Superiority or Other (legacy) |
| 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.373 | LS Mean Difference | -0.4 | 2-Sided | 95 | -1.27 | 0.48 | Superiority or Other (legacy) |
| 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.413 | 2-Sided | Superiority or Other (legacy) |
| 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.317 | LS Mean Difference | -0.4 | 2-Sided | 95 | -1.22 | 0.40 | Superiority or Other (legacy) |
| 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.708 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.66 | 0.97 | Superiority or Other (legacy) |
| 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.202 | LS Mean Difference | -0.6 | 2-Sided | 95 | -1.44 | 0.31 | Superiority or Other (legacy) |
| 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.190 | 2-Sided | Superiority or Other (legacy) |
| 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.094 | LS Mean Difference | -0.7 | 2-Sided | 95 | -1.44 | 0.11 | Superiority or Other (legacy) |
| 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.960 | LS Mean Difference | -0.0 | 2-Sided | 95 | -0.80 | 0.76 | Superiority or Other (legacy) |
| 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms. | ANOVA | 0.132 | LS Mean Difference | -0.6 | 2-Sided | 95 | -1.48 | 0.20 | Superiority or Other (legacy) |
|
| 48-72 hours |
|
| 0-72 hours |
|
| ANOVA |
| 0.162 |
| LS Mean Difference |
| 4.6 |
| 2-Sided |
| 95 |
| -1.86 |
| 11.02 |
| Superiority or Other (legacy) |
| 0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.559 | LS Mean Difference | -1.9 | 2-Sided | 95 | -8.42 | 4.57 | Superiority or Other (legacy) |
| 0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.066 | LS Mean Difference | 6.5 | 2-Sided | 95 | -0.44 | 13.45 | Superiority or Other (legacy) |
| 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.957 | 2-Sided | Superiority or Other (legacy) |
| 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.864 | LS Mean Difference | 1.1 | 2-Sided | 95 | -11.20 | 13.33 | Superiority or Other (legacy) |
| 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.883 | LS Mean Difference | -0.9 | 2-Sided | 95 | -13.30 | 11.45 | Superiority or Other (legacy) |
| 24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.767 | LS Mean Difference | 2.0 | 2-Sided | 95 | -11.24 | 15.22 | Superiority or Other (legacy) |
| 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.243 | 2-Sided | Superiority or Other (legacy) |
| 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.176 | LS Mean Difference | -8.2 | 2-Sided | 95 | -20.12 | 3.70 | Superiority or Other (legacy) |
| 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.741 | LS Mean Difference | 2.0 | 2-Sided | 95 | -10.00 | 14.03 | Superiority or Other (legacy) |
| 48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.118 | LS Mean Difference | -10.2 | 2-Sided | 95 | -23.07 | 2.62 | Superiority or Other (legacy) |
| 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.920 | 2-Sided | Superiority or Other (legacy) |
| 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.685 | LS Mean Difference | -4.2 | 2-Sided | 95 | -24.64 | 16.23 | Superiority or Other (legacy) |
| 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.892 | LS Mean Difference | -1.4 | 2-Sided | 95 | -22.04 | 19.19 | Superiority or Other (legacy) |
| 0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.804 | LS Mean Difference | -2.8 | 2-Sided | 95 | -24.82 | 19.25 | Superiority or Other (legacy) |
| ANOVA |
| 0.266 |
| LS Mean Difference |
| 0.5 |
| 2-Sided |
| 95 |
| -0.38 |
| 1.38 |
| Superiority or Other (legacy) |
| Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms. | ANOVA | 0.730 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.74 | 1.05 | Superiority or Other (legacy) |
| Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms. | ANOVA | 0.479 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.61 | 1.30 | Superiority or Other (legacy) |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 7 hours |
|
| 8 hours |
|
| 9 hours |
|
| 10 hours |
|
| 11 hours |
|
| 12 hours |
|
| 24 hours |
|
| 30 hours |
|
| 36 hours |
|
| 48 hours |
|
| 54 hours |
|
| 60 hours |
|
| 72 hours |
|
| ANOVA |
| 0.389 |
| LS Mean Difference |
| -0.1 |
| 2-Sided |
| 95 |
| -0.17 |
| 0.07 |
| Superiority or Other (legacy) |
| 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.273 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.05 | 0.19 | Superiority or Other (legacy) |
| 1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.069 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.25 | 0.01 | Superiority or Other (legacy) |
| 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.716 | 2-Sided | Superiority or Other (legacy) |
| 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.735 | LS Mean Difference | -0.0 | 2-Sided | 95 | -0.15 | 0.11 | Superiority or Other (legacy) |
| 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.414 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.19 | 0.08 | Superiority or Other (legacy) |
| 2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.652 | LS Mean Difference | 0.0 | 2-Sided | 95 | -0.11 | 0.17 | Superiority or Other (legacy) |
| 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.622 | 2-Sided | Superiority or Other (legacy) |
| 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.830 | LS Mean Difference | 0.0 | 2-Sided | 95 | -0.17 | 0.21 | Superiority or Other (legacy) |
| 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.442 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.26 | 0.11 | Superiority or Other (legacy) |
| 3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.358 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.11 | 0.29 | Superiority or Other (legacy) |
| 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.714 | 2-Sided | Superiority or Other (legacy) |
| 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.683 | LS Mean Difference | -0.0 | 2-Sided | 95 | -0.29 | 0.19 | Superiority or Other (legacy) |
| 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.413 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.34 | 0.14 | Superiority or Other (legacy) |
| 4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.699 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.21 | 0.31 | Superiority or Other (legacy) |
| 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.244 | 2-Sided | Superiority or Other (legacy) |
| 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.833 | LS Mean Difference | 0.0 | 2-Sided | 95 | -0.21 | 0.26 | Superiority or Other (legacy) |
| 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.156 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.41 | 0.07 | Superiority or Other (legacy) |
| 5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.128 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.06 | 0.46 | Superiority or Other (legacy) |
| 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.359 | 2-Sided | Superiority or Other (legacy) |
| 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.278 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.12 | 0.43 | Superiority or Other (legacy) |
| 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.699 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.33 | 0.22 | Superiority or Other (legacy) |
| 6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.172 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.09 | 0.50 | Superiority or Other (legacy) |
| 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.515 | 2-Sided | Superiority or Other (legacy) |
| 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.527 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.19 | 0.37 | Superiority or Other (legacy) |
| 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.545 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.37 | 0.19 | Superiority or Other (legacy) |
| 7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.250 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.12 | 0.47 | Superiority or Other (legacy) |
| 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.568 | 2-Sided | Superiority or Other (legacy) |
| 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.381 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.16 | 0.41 | Superiority or Other (legacy) |
| 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.863 | LS Mean Difference | -0.0 | 2-Sided | 95 | -0.31 | 0.26 | Superiority or Other (legacy) |
| 8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.330 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.16 | 0.46 | Superiority or Other (legacy) |
| 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.167 | 2-Sided | Superiority or Other (legacy) |
| 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.165 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.09 | 0.50 | Superiority or Other (legacy) |
| 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.564 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.39 | 0.21 | Superiority or Other (legacy) |
| 9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.068 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.02 | 0.62 | Superiority or Other (legacy) |
| 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.131 | 2-Sided | Superiority or Other (legacy) |
| 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.119 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.06 | 0.56 | Superiority or Other (legacy) |
| 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.616 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.39 | 0.23 | Superiority or Other (legacy) |
| 10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.056 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.01 | 0.66 | Superiority or Other (legacy) |
| 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.255 | 2-Sided | Superiority or Other (legacy) |
| 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.144 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.08 | 0.57 | Superiority or Other (legacy) |
| 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.935 | LS Mean Difference | -0.0 | 2-Sided | 95 | -0.34 | 0.31 | Superiority or Other (legacy) |
| 11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.153 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.10 | 0.61 | Superiority or Other (legacy) |
| 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.128 | 2-Sided | Superiority or Other (legacy) |
| 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.067 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.02 | 0.63 | Superiority or Other (legacy) |
| 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.999 | LS Mean Difference | -0.0 | 2-Sided | 95 | -0.33 | 0.33 | Superiority or Other (legacy) |
| 12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.088 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.05 | 0.66 | Superiority or Other (legacy) |
| 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.195 | 2-Sided | Superiority or Other (legacy) |
| 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.175 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.12 | 0.67 | Superiority or Other (legacy) |
| 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.610 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.50 | 0.30 | Superiority or Other (legacy) |
| 24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.083 | LS Mean Difference | 0.4 | 2-Sided | 95 | -0.05 | 0.81 | Superiority or Other (legacy) |
| 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.884 | 2-Sided | Superiority or Other (legacy) |
| 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.833 | LS Mean Difference | -0.0 | 2-Sided | 95 | -0.43 | 0.35 | Superiority or Other (legacy) |
| 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.620 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.49 | 0.29 | Superiority or Other (legacy) |
| 30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.788 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.36 | 0.48 | Superiority or Other (legacy) |
| 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.755 | 2-Sided | Superiority or Other (legacy) |
| 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.787 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.45 | 0.34 | Superiority or Other (legacy) |
| 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.455 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.56 | 0.25 | Superiority or Other (legacy) |
| 36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.654 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.33 | 0.53 | Superiority or Other (legacy) |
| 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.370 | 2-Sided | Superiority or Other (legacy) |
| 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.472 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.51 | 0.24 | Superiority or Other (legacy) |
| 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.427 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.23 | 0.53 | Superiority or Other (legacy) |
| 48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.159 | LS Mean Difference | -0.3 | 2-Sided | 95 | -0.69 | 0.11 | Superiority or Other (legacy) |
| 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.480 | 2-Sided | Superiority or Other (legacy) |
| 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.238 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.59 | 0.15 | Superiority or Other (legacy) |
| 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.794 | LS Mean Difference | -0.0 | 2-Sided | 95 | -0.42 | 0.32 | Superiority or Other (legacy) |
| 54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.395 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.57 | 0.23 | Superiority or Other (legacy) |
| 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.400 | 2-Sided | Superiority or Other (legacy) |
| 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.176 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.61 | 0.11 | Superiority or Other (legacy) |
| 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.573 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.47 | 0.26 | Superiority or Other (legacy) |
| 60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.466 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.53 | 0.24 | Superiority or Other (legacy) |
| 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.092 | 2-Sided | Superiority or Other (legacy) |
| 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.086 | LS Mean Difference | -0.3 | 2-Sided | 95 | -0.67 | 0.04 | Superiority or Other (legacy) |
| 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.616 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.27 | 0.45 | Superiority or Other (legacy) |
| 72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms. | ANOVA | 0.040 | LS Mean Difference | -0.4 | 2-Sided | 95 | -0.79 | -0.02 | Superiority or Other (legacy) |
Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.
| Cochran-Mantel-Haenszel |
| 0.696 |
| Weighted Gamma Statistic |
| -0.0 |
| 2-Sided |
| 95 |
| -0.28 |
| 0.20 |
| Superiority or Other (legacy) |
| Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex. | Cochran-Mantel-Haenszel | 0.760 | Weighted Gamma Statistic | 0.0 | 2-Sided | 95 | -0.21 | 0.29 | Superiority or Other (legacy) |
| Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex. | Cochran-Mantel-Haenszel | 0.463 | Weighted Gamma Statistic | -0.1 | 2-Sided | 95 | -0.36 | 0.16 | Superiority or Other (legacy) |