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EGF is a polypeptide that promotes cell differentiation and collagen production while decreasing melanin production. This study is designed to study its effectiveness in improving the texture and appearance of facial skin after daily topical application. We hypothesized that EGF would improve facial skin hydration, elasticity, pigmentation, and wrinkles.
All patients gave written informed consent for epidermal growth factor serum application on the face. The pilot study enrolls thirty patients compared to pre and post-serum used to evaluate facial skin hydration, transepidermal water loss, elasticity, pigmentation, and wrinkles measured by corneometer, tewameter, cutometer, visioscan, and mexameter respectively on day 0, then 8, 12, and 16 weeks. The study evaluates subject satisfaction and side effects after serum application as secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidermal Growth Factor Serum Application | Experimental | Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidermal Growth Factor | Drug | Apply facial twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Facial Skin Hydration | Facial skin hydration was measured using a Corneometer, which provides readings in arbitrary units (a.u.). Measurements were taken at baseline (Day 0), Week 8, Week 12, and Week 16 under standardized environmental and procedural conditions to ensure reliability and accuracy. Higher values indicate better skin hydration, while lower values indicate increased dryness. | 4 months (Baseline, Week 8, Week 12, Week 16) |
| Transepidermal Water Loss | measured by tewameter on day 0, then at 8, 12, and 16 weeks. | 4 months |
| Facial Skin Elasticity (R2 Parameter Via Cutometer) | Skin elasticity was assessed using a Cutometer with the R2 parameter (Ua/Uf), which measures gross elasticity. R2 values range from 0 to 1.0, with higher values indicating better skin elasticity. Measurements were collected under standardized conditions at Baseline (Day 0), Week 8, Week 12, and Week 16. | Baseline, Week 8, Week 12, Week 16 |
| Facial Skin Wrinkles | Visioscan measurements were taken at baseline, then at 8, 12, and 16 weeks by using a 4-grade percentage wrinkle improvement scale. | 4 months |
| Facial Melanin Index | Facial pigmentation was assessed using the Mexameter, which measures melanin content via light absorption and reflection. The device reports values on a scale from 0 to 999, where higher values represent greater melanin concentration. Measurements were collected at standardized facial sites at Baseline, Week 8, Week 12, and Week 16. Higher scores indicate worse pigmentation. | 4 months |
| Overall Facial Skin Appearance (Photo Evaluation Using SGAIS) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation | Using a quartile grading system, (0 = unsatisfied), (1 = slightly satisfied), (2 = satisfied), and (3 = very satisfied) | 4 months |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chumsaeng Chumsaengsri | Institute of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Dermatology | Bangkok | 10400 | Thailand |
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Pre-assignment Details of 28 enrolled participants, all met inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Epidermal Growth Factor Serum Application | Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality. Epidermal Growth Factor: Apply facial twice daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Twenty-eight patients participated in a pilot study. The study involved pre- and post-serum assessments at four different time points (0, 8, 12, and 16 weeks). Various instruments, including tewameter, corneometer, cutometer, mexameter, and visioscan, were used for measurements.
| ID | Title | Description |
|---|---|---|
| BG000 | Epidermal Growth Factor Serum Application | Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality. Epidermal Growth Factor: Apply facial twice daily. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Facial Skin Hydration | Facial skin hydration was measured using a Corneometer, which provides readings in arbitrary units (a.u.). Measurements were taken at baseline (Day 0), Week 8, Week 12, and Week 16 under standardized environmental and procedural conditions to ensure reliability and accuracy. Higher values indicate better skin hydration, while lower values indicate increased dryness. | The analysis population included 28 subjects initially recruited for this study. Participants were assessed at four time points: baseline (Day 0), Week 8, Week 12, and Week 16. One participant was lost to follow-up after Week 12 and Week 16. | Posted | Mean | Standard Deviation | arbitrary units | 4 months (Baseline, Week 8, Week 12, Week 16) | face | face |
|
Baseline, Week 8, Week 12, Week 16
Adverse events, including erythema, edema, hyperpigmentation, skin infection, itching, irritation, burning sensation, papules, and acne, were monitored at multiple time points. No adverse events were reported. All 28 enrolled participants were monitored for adverse events, and therefore the Total Number of Participants at Risk is 28 across all adverse event tables.
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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 | Epidermal Growth Factor Serum Application | Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality. Epidermal Growth Factor: Apply facial twice daily. |
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The small sample size should be considered. Further research involving a larger population or control group is recommended for conclusive insights into the efficacy of EGF serum.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Supawee Phanmamuang | Institute of Dermatology, Thailand | 6623545222 | dewsupawee@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2023 | Jan 9, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D004815 | Epidermal Growth Factor |
| ID | Term |
|---|---|
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D066255 | EGF Family of Proteins |
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Facial skin appearance was evaluated using the Subject Global Aesthetic Improvement Scale (SGAIS), a 5-point scale where higher scores indicate greater improvement. Scores were assigned by two board-certified dermatologists who assessed photographs taken by the Visia-CR imaging system at Baseline, Week 8, Week 12, and Week 16. SGAIS scoring definition: 1 = Worse, 2 = Mild improvement (<25%), 3 = Moderate (25-49%), 4 = Much improved (50-74%), 5 = Very much improved (≥75%). |
| 4 months |
Adverse events were systematically monitored at 2, 4, 8, 12, and 16 weeks post-treatment initiation.
| 4 months |
| face |
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| ัyears |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| Underlying disease | Count of Participants | Participants | Participants |
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| Occupation | Count of Participants | Participants | Participants |
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| Fitzpatrick skin type | Participants were classified using the Fitzpatrick Skin Type Scale, which ranges from Type I (very fair skin, always burns, never tans) to Type VI (deeply pigmented skin, never burns). Classification was based on self-reported skin response to sun exposure and visual assessment. In this study, Types I-II were considered more sensitive to treatment-related skin reactions (worse outcomes), while Types V-VI, with higher melanin levels, were considered less prone to visible reactions (better outcomes). | Count of Participants | Participants | Participants |
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| Hormone use | Count of Participants | Participants | Participants |
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| Pregnancy | Count of Participants | Participants | Participants |
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| Menopause | Count of Participants | Participants | Participants |
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| Smoking | Count of Participants | Participants | Participants |
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| Alcohol drinking | Count of Participants | Participants | Participants |
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| Regular sun expose | Count of Participants | Participants | Participants |
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| Primary | Transepidermal Water Loss | measured by tewameter on day 0, then at 8, 12, and 16 weeks. | The analysis population for this study on Transepidermal Water Loss (TEWL) utilizing Tewameter measurements comprised a total of 28 initially recruited subjects. These participants were assessed at four distinct time points: day 0 (baseline), 8 weeks, 12 weeks, and 16 weeks. One subject loss follow-up at week 12 and week 16. | Posted | Mean | Standard Deviation | g/m²·h | 4 months | face | face |
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| Primary | Facial Skin Elasticity (R2 Parameter Via Cutometer) | Skin elasticity was assessed using a Cutometer with the R2 parameter (Ua/Uf), which measures gross elasticity. R2 values range from 0 to 1.0, with higher values indicating better skin elasticity. Measurements were collected under standardized conditions at Baseline (Day 0), Week 8, Week 12, and Week 16. | 28 participants were assessed at Baseline and Week 8. One participant was lost to follow-up after Week 8, resulting in 27 participants at Weeks 12 and 16. Skin elasticity was measured using the R2 parameter from Cutometer readings at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8, Week 12, Week 16 | face | face |
|
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| Primary | Facial Skin Wrinkles | Visioscan measurements were taken at baseline, then at 8, 12, and 16 weeks by using a 4-grade percentage wrinkle improvement scale. | The analysis population for this study on facial skin wrinkles using Visioscan included 28 subjects, assessed at Day 0 (baseline), Week 8, Week 12, and Week 16. One subject dropped out at Week 12 and another at Week 16, leaving data from 27 participants for Weeks 12 and 16. Wrinkle improvement was assessed on a 4-grade scale: Grade 1 (0-25%) = slight, Grade 2 (25-50%) = moderate, Grade 3 (50-75%) = marked, Grade 4 (>75%) = significant. Data are presented as mean grades with standard deviation. | Posted | Mean | Standard Deviation | units on a scale | 4 months | face | face |
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| Primary | Facial Melanin Index | Facial pigmentation was assessed using the Mexameter, which measures melanin content via light absorption and reflection. The device reports values on a scale from 0 to 999, where higher values represent greater melanin concentration. Measurements were collected at standardized facial sites at Baseline, Week 8, Week 12, and Week 16. Higher scores indicate worse pigmentation. | The analysis population for this study on facial skin pigmentation utilizing Mexameter measurements comprised a total of 28 initially recruited subjects. These participants were assessed at four distinct time points: day 0 (baseline), 8 weeks, 12 weeks, and 16 weeks. One subject loss follow-up at week 12 and week 16. | Posted | Mean | Standard Deviation | unitless index | 4 months | face | face |
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| Primary | Overall Facial Skin Appearance (Photo Evaluation Using SGAIS) | Facial skin appearance was evaluated using the Subject Global Aesthetic Improvement Scale (SGAIS), a 5-point scale where higher scores indicate greater improvement. Scores were assigned by two board-certified dermatologists who assessed photographs taken by the Visia-CR imaging system at Baseline, Week 8, Week 12, and Week 16. SGAIS scoring definition: 1 = Worse, 2 = Mild improvement (<25%), 3 = Moderate (25-49%), 4 = Much improved (50-74%), 5 = Very much improved (≥75%). | The analysis population included 28 subjects assessed at baseline, 8, 12, and 16 weeks. One participant was lost to follow-up after week 12. | Posted | Count of Participants | Participants | 4 months |
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| Secondary | Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation | Using a quartile grading system, (0 = unsatisfied), (1 = slightly satisfied), (2 = satisfied), and (3 = very satisfied) | The assessment of participant satisfaction post-treatment involves all twenty-eight participants, with evaluations at 2, 3, and 4 months using a quartile grading system (0 = unsatisfied, 1 = slightly satisfied, 2 = satisfied, 3 = very satisfied). It is important to note that one subject was lost to follow-up since the 12-week mark. | Posted | Count of Participants | Participants | 4 months |
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| Secondary | Adverse Events | Adverse events were systematically monitored at 2, 4, 8, 12, and 16 weeks post-treatment initiation. | The comprehensive evaluation encompassed a total of 28 subjects. One participant was lost to follow-up at the 12-week mark. Adverse events were systematically monitored through video calls at 2 and 4 weeks post-treatment initiation. On-site evaluations were conducted at 8, 12, and 16 weeks. At each time point, the number of participants analyzed was 28, with one participant lost to follow-up at the 12-week and 16-week evaluations. | Posted | Count of Participants | Participants | 4 months |
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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| 8 weeks |
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| 12 weeks |
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| 16 weeks |
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| 8 wk |
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| 12 wk |
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| 16 wk |
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| Superiority |
The chosen test was designed to assess whether application of the intervention resulted in any statistically significant differences over time in the primary outcome measure, assuming superiority. |
| 8 wk |
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| 12 wk |
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| 16 wk |
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| 8 weeks |
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| 12 weeks |
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| 16 weeks |
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| Superiority |
Repeated measures ANOVA was used to detect any change in facial melanin levels due to the intervention. |
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| 8 weeks Doctor 1 : score 3 |
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| 8 weeks Doctor 1 : score 4 |
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| 8 weeks Doctor 2 : score 1 |
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| 8 weeks Doctor 2 : score 2 |
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| 8 weeks Doctor 2 : score 3 |
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| 8 weeks Doctor 2 : score 4 |
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| 12 weeks Doctor 1 : score 1 |
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| 12 weeks Doctor 1 : score 2 |
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| 12 weeks Doctor 1 : score 3 |
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| 12 weeks Doctor 1 : score 4 |
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| 12 weeks Doctor 2 : score 1 |
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| 12 weeks Doctor 2 : score 2 |
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| 12 weeks Doctor 2 : score 3 |
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| 12 weeks Doctor 2 : score 4 |
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| 16 weeks Doctor 1 : score 1 |
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| 16 weeks Doctor 1 : score 2 |
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| 16 weeks Doctor 1 : score 3 |
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| 16 weeks Doctor 1 : score 4 |
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| 16 weeks Doctor 2 : score 1 |
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| 16 weeks Doctor 2 : score 2 |
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| 16 weeks Doctor 2 : score 3 |
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| 16 weeks Doctor 2 : score 4 |
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| Superiority |
A descriptive analysis was performed. No hypothesis testing or power calculation was conducted for this outcome. |
| Title | Measurements |
|---|---|
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| 8 weeks : unsatisfied |
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| 8 weeks : NA (loss follow up) |
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| 12 weeks : very satisfied |
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| 12 weeks : satisfied |
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| 12 weeks : slightly satisfied |
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| 12 weeks : unsatisfied |
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| 12 weeks : NA (loss follow up) |
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| 16 weeks : very satisfied |
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| 16 weeks : satisfied |
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| 16 weeks : slightly satisfied |
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| 16 weeks : unsatisfied |
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| 16 weeks : NA (loss follow up) |
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| Title | Measurements |
|---|---|
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| 4 weeks : No adverse event |
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| 4 weeks : Yes adverse event |
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| 4 weeks :Data missing |
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| 8 weeks : No adverse event |
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| 8 weeks : Yes adverse event |
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| 8 weeks : Data missing |
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| 12 weeks : No adverse event |
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| 12 weeks : Yes adverse event |
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| 12 weeks : Data missing |
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| 16 weeks : No adverse event |
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| 16 weeks : Yes adverse event |
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| 16 weeks : Data missing |
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