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This study is to evaluate available local data in Iraqi patients with moderate to severe psoriasis on Enbrel treatment with regards to efficacy, treatment regimen adherence and patient characterization (i.e. age, gender, smoking status) using data from the Dermatologists in Baghdad Teaching Hospital registry
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with moderate to severe plaque psoriasis | Iraqi patients diagnosed with moderate to severe plaque psoriasis that received Enbrel as treatment for disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enbrel | Drug | As provided in real world practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percent Body Surface Area (BSA) at Month 12 | Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint equal to (=) 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. | Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study) |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12 | DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. | Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study) |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12 | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of body region was counted. Maximum number of handprints were 10 for head and neck,20 for upper limbs,30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. % BSA for body region=total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA=greater severity of psoriasis. This outcome measure evaluated comparison in % BSA between participants adherent and not adherent to treatment at Baseline, Month 4 and 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percent Body Surface Area (BSA) at Month 4 | Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. |
Inclusion Criteria:
Exclusion Criteria:
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Patients data from the local registry at the Dermatology Center of Baghdad Teaching Hospital registry.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Baghdad | Iraq |
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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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Data of Iraq's participants aged greater than or equal to (>=) 18 years, who received etanercept for at least 1 year for treatment of moderate to severe plaque psoriasis at dermatology center in the Baghdad teaching hospital were included in the study. Available data of maximum 5 years were evaluated in approximately 2.8 months of this retrospective, observational study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept [Enbrel] is 25 milligrams [mg] administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis was performed on all participants whose data were included in this study for retrospective observation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study. |
| 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 | Change From Baseline in Percent Body Surface Area (BSA) at Month 12 | Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint equal to (=) 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. | Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent BSA | Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study) |
Not applicable as adverse events were not collected for the study
Due to non-interventional nature of study, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not meet, hence adverse events were not collected and reported.
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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 | Etanercept | Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study. |
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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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| 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 | Jul 28, 2021 | Sep 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study) |
| Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study) |
| Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment | DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison in DLQI score between participants adherent and not adherent to treatment at Baseline, Month 4 and 12. | Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study) |
| Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison in PASI score between participants adherent and not adherent to treatment at Baseline, Month 4 and 12. | Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study) |
| Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study) |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4 | DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. | Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study) |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4 | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. | Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Etanercept | Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study. |
|
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| Primary | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12 | DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. | Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study) |
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| Primary | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12 | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. | Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study) |
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| Secondary | Percent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment | Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of body region was counted. Maximum number of handprints were 10 for head and neck,20 for upper limbs,30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. % BSA for body region=total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA=greater severity of psoriasis. This outcome measure evaluated comparison in % BSA between participants adherent and not adherent to treatment at Baseline, Month 4 and 12. | Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Number Analyzed" signifies participants evaluable at specific time points. | Posted | Mean | Standard Deviation | Percent BSA | Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study) |
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| Secondary | Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment | DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison in DLQI score between participants adherent and not adherent to treatment at Baseline, Month 4 and 12. | Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Number Analyzed" signifies participants evaluable at specific time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study) |
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| Secondary | Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison in PASI score between participants adherent and not adherent to treatment at Baseline, Month 4 and 12. | Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Number Analyzed" signifies participants evaluable at specific time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study) |
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| Other Pre-specified | Change From Baseline in Percent Body Surface Area (BSA) at Month 4 | Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. | Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent BSA | Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study) |
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| Other Pre-specified | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4 | DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. | Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study) |
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| Other Pre-specified | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4 | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. | Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study) |
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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.
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| Month 4 |
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| Month 12 |
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| Other |
| Month 12 | Student's t-test | 0.0001 | Other |
| Month 4 |
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| Month 12 |
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| Other |
| Month 12 | Student's t-test | 0.0001 | Other |
| Month 4 |
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| Month 12 |
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| Other |
| Month 12 | Student's t-test | 0.0001 | Other |