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| ID | Type | Description | Link |
|---|---|---|---|
| U0280-402 |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.
This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olux-E Foam | Experimental | Olux-E (clobetasol propionate 0.05%) foam |
|
| Clobex lotion | Active Comparator | Clobex (clobetasol propionate 0.05%) lotion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olux-E Foam | Drug | Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15. |
| Measure | Description | Time Frame |
|---|---|---|
| At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale) | Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation. | Baseline to day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| At Least 1 Grade Improvement Psoriasis Grading Scale | Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5). | Baseline, days 3 and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences Department of Dermatology | Winston-Salem | North Carolina | 27157 | United States |
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Clinical research center
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| ID | Title | Description |
|---|---|---|
| FG000 | Olux-E Foam | Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser. |
| FG001 | Clobex Lotion | Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Olux-E Foam | Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser. |
| BG001 | Clobex Lotion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale) | Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation. | ITT | Posted | Number | participants | Baseline to day 15 |
|
Baseline through Day 15.
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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 | Olux-E Foam | Olux-E (clobetasol propionate 0.05%) foam |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA, Version 11.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Not provided
| ID | Term |
|---|---|
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Clobex lotion | Drug | Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15 |
|
|
| At Least a 2 Grade Improvement Psoriasis Grading Scale |
Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5). |
| Baseline, days 3, 8, 15 |
| At Least a 3 Grade Improvement Psoriasis Grading Scale | Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5). | Baseline, days 3, 8, 15 |
| At Least 1 Grade Improvement in the Psoriasis Global Assessment | Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. | Baseline, days 3, 8, 15 |
| At Least a 2 Grade Improvement in the Psoriasis Global Assessment | Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. | Baseline, days 3, 8, 15 |
| At Least a 3 Grade Improvement in the Psoriasis Global Assessment | Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. | Baseline, days 3, 8, 15 |
| At Least 1 Grade Improvement in Subject's Global Assessment | Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques. | Baseline, days 3, 8, 15 |
| At Least a 2 Grade Improvement in Subject's Global Assessment | Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques. | Baseline, days 3, 8, 15 |
| At Least a 3 Grade Improvement in Subject's Global Assessment | Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques. | Baseline, days 3, 8, 15 |
| Median Change in Psoriasis Grading Scale | Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation. | Baseline, Days 3, 8, 15 |
| Dermatology Quality of Life - Symptoms and Feelings | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life | Baseline, Days 3, 8, 15 |
| Dermatology Quality of Life - Daily Activities | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life | Baseline, Days 3, 8, 15 |
| Dermatology Quality of Life - Leisure | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life | Baseline, Days 3, 8, 15 |
| Dermatology Quality of Life - Work and School | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life | Baseline, Days 3, 8, 15 |
| Dermatology Quality of Life - Personal Relationships | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life | Baseline, Days 3, 8, 15 |
| Dermatology Quality of Life - Treatment | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life | Baseline, Days 3, 8, 15 |
| Total Dermatology Life Quality Index (DLQI) Score | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life | Baseline, Days 3, 8, 15 |
| Dermatology Life Quality Index (DLQI) Categories | Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life. | Days 3, 8, 15 |
Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women and is measured in kg/m^2. | Mean | Standard Deviation | kg/m^2 |
|
| OG001 |
| Clobex Lotion |
Clobex (clobetasol propionate 0.05%) lotion. |
|
|
| Secondary | At Least 1 Grade Improvement Psoriasis Grading Scale | Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5). | Intent to treat (ITT) | Posted | Number | participants | Baseline, days 3 and 8 |
|
|
|
|
| Secondary | At Least a 2 Grade Improvement Psoriasis Grading Scale | Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5). | Intent to treat (ITT) | Posted | Number | participants | Baseline, days 3, 8, 15 |
|
|
|
|
| Secondary | At Least a 3 Grade Improvement Psoriasis Grading Scale | Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5). | Intent to treat (ITT) | Posted | Number | participants | Baseline, days 3, 8, 15 |
|
|
|
|
| Secondary | At Least 1 Grade Improvement in the Psoriasis Global Assessment | Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. | Intent to treat (ITT) | Posted | Number | participants | Baseline, days 3, 8, 15 |
|
|
|
| Secondary | At Least a 2 Grade Improvement in the Psoriasis Global Assessment | Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. | Intent to treat (ITT) | Posted | Number | participants | Baseline, days 3, 8, 15 |
|
|
|
|
| Secondary | At Least a 3 Grade Improvement in the Psoriasis Global Assessment | Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. | Intent to treat (ITT) | Posted | Number | participants | Baseline, days 3, 8, 15 |
|
|
|
| Secondary | At Least 1 Grade Improvement in Subject's Global Assessment | Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques. | Intent to treat (ITT) | Posted | Number | participants | Baseline, days 3, 8, 15 |
|
|
|
|
| Secondary | At Least a 2 Grade Improvement in Subject's Global Assessment | Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques. | Intent to treat (ITT) | Posted | Number | participants | Baseline, days 3, 8, 15 |
|
|
|
|
| Secondary | At Least a 3 Grade Improvement in Subject's Global Assessment | Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques. | Intent to treat (ITT) | Posted | Number | participants | Baseline, days 3, 8, 15 |
|
|
|
|
| Secondary | Median Change in Psoriasis Grading Scale | Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation. | ITT | Posted | Median | Inter-Quartile Range | unites on a scale | Baseline, Days 3, 8, 15 |
|
|
|
| Secondary | Dermatology Quality of Life - Symptoms and Feelings | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life | ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Days 3, 8, 15 |
|
|
|
| Secondary | Dermatology Quality of Life - Daily Activities | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life | ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Days 3, 8, 15 |
|
|
|
| Secondary | Dermatology Quality of Life - Leisure | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life | ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Days 3, 8, 15 |
|
|
|
| Secondary | Dermatology Quality of Life - Work and School | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life | ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Days 3, 8, 15 |
|
|
|
| Secondary | Dermatology Quality of Life - Personal Relationships | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life | ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Days 3, 8, 15 |
|
|
|
| Secondary | Dermatology Quality of Life - Treatment | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life | ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Days 3, 8, 15 |
|
|
|
| Secondary | Total Dermatology Life Quality Index (DLQI) Score | Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life | ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Days 3, 8, 15 |
|
|
|
| Secondary | Dermatology Life Quality Index (DLQI) Categories | Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life. | Posted | Number | participants | Days 3, 8, 15 |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Clobex Lotion | Clobex (clobetasol propionate 0.05%) lotion. | 0 | 17 | 2 | 17 |
| Dizziness | Nervous system disorders | MedDRA, Version 11.1 | Non-systematic Assessment |
|
| Hpertension | Vascular disorders | MedDRA, Version 11.1 | Non-systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D011083 |
| Polycyclic Compounds |
This is the result for the Day 8 analysis. |
| No |
| Superiority or Other |
| Day 15 |
|
This is the result for the Day 8 analysis. |
| No |
| Superiority or Other |
| Chi-squared | 0.0060 | This is the result for the Day 15 analysis. | 95 | No | Superiority or Other |
| Day 15 |
|
| Day 15 |
|
This is the result for the Day 8 analysis. |
| 95 |
| No |
| Superiority or Other |
| Chi-squared | 0.0135 | This is the p value for day 15 | No | Superiority or Other |
| Day 15 |
|
| Day 15 |
|
P value at day 3. |
| No |
| Superiority or Other |
| Chi-squared | 0.5454 | P value at day 8. | No | Superiority or Other |
| Day 15 |
|
This is the p value for day 8. |
| No |
| Superiority or Other |
| Chi-squared | 0.6715 | This is the p value for day 3. | No | Superiority or Other |
| Day 15 |
|
P value on day 15. |
| No |
| Superiority or Other |
| Day 15 |
|
| Day 15, n=17, 17 |
|
| Day 15, n=17, 17 |
|
| Day 15, n=17, 17 |
|
| Day 15, n=17, 17 |
|
| Day 15, n=17, 17 |
|
| Day 15, n=17, 17 |
|
| Day 15 |
|
| Day 3 Score 6- 10 Moderate effect |
|
| Day 3 Score 11- 20 Very large effect |
|
| Day 8 Score 0 -1 No effect |
|
| Day 8 Score 2- 5 Small effect |
|
| Day 8 Score 6- 10 Moderate effect |
|
| Day 8 Score 11- 20 Very large effect |
|
| Day 15 Score 0 -1 No effect |
|
| Day 15 Score 2- 5 Small effect |
|
| Day 15 Score 6- 10 Moderate effect |
|
| Day 15 Score 11- 20 Very large effect |
|