Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is aimed at evaluating the efficacy and tolerability of systemic pharmacotherapy as a part of combination treatment, and its influence on the overall treatment outcomes in patients with skin changes (CEAP class C4a and C4b).
Primary goal:
To study the efficacy of systemic pharmacotherapy as part of combination therapy and its impact on the:
Secondary goals:
To study the efficacy of systemic pharmacotherapy as part of combination therapy and its impact on the:
To evaluate the changes in the quality of life using the CIVIQ-14 questionnaire (global index score [GIS]) .
To study the tolerability of systemic pharmacotherapy as part of combination therapy in patients with skin changes of CEAP class C4a or C4b.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Subcutaneous Adipose Tissue Thickness Changes (mm) Between the Visit 3 and Baseline by Ultrasound Examination. | Ultrasound examination was used to get:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Changes VCSS for Pain (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale | Was used four-point scale the Venous Clinical Severity Score(VCSS ). It uses a number of clinical signs, which are assigned a point equivalent depending on their severity (pain, varicose veins, edema, hyperpigmentation, inflammation, induration, the number of ulcers, the presence of active ulcers, the use of compression therapy). The sum of points reflects the severity of the pathology: the more points, the more severe the course of chronic venous disease. Changing the amount of points over time allows you to assess the degree of disease progression or the effectiveness of treatment measures. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Treatment with drugs potentially causing leg edema (calcium channel blockers, hormonal drugs, NSAIDs, etc.) History of deep vein thrombosis (within the past year) History of superficial thrombophlebitis (within the past 3 months) History of surgical intervention (within the past 3 months) Patient cannot walk (regardless of the cause) Predictable poor adherence to treatment Participation of a patient in the intervention study within the previous 3 months For women: pregnancy or breastfeeding, the desire to become pregnant within at least 2 months after the study Patients with a contraindication to diosmin-containing agents, including Detralex Patient uses the topical treatments contraindicated in case of skin integrity violation.
Not provided
Not provided
Not provided
patients with chronic venous diseases of CEAP class C4a and C4b
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Olga Linnik | Medical manager | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Medical and Surgical Center. N.I. Pirogov | Moscow | 105203 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41776914 | Derived | Bogachev VY, Boldin BV, Turkin PY, Varich GA, Samenkov AY; VAP-PRO-C4 Study Investigators Group. [Objective control over efficacy of therapy for trophic skin disorders in chronic venous insufficiency of lower limbs]. Angiol Sosud Khir. 2023 Jun 21;29(2):143-149. doi: 10.33029/1027-6661-2023-29-2-143-149. Russian. | |
| 36004765 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice | The study enrolled adults (≥18 years old) with CVD of CEAP class C4 (a or b) severity whose physicians recommended the initiation of MPFF (1000 mg/day) in addition to conservative treatment according to routine clinical practice, and for whom surgical intervention for their CVD was not currently planned |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice | According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Mean Subcutaneous Adipose Tissue Thickness Changes (mm) Between the Visit 3 and Baseline by Ultrasound Examination. | Ultrasound examination was used to get:
| Posted | Mean | Standard Deviation | mm | 6 months |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice | According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Manager-Olga Linnik | ServierRussia | 8-495-93707-00 | 1316 | olga.linnik@servier.com |
Not provided
| 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 | Oct 2, 2019 | Jun 21, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 2, 2019 | Jun 21, 2021 | ICF_001.pdf |
Not provided
Not provided
Not provided
Not provided
| 6 months |
| The Mean Changes VCSS for Hyperpigmentation (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale | Was used four-point scale the Venous Clinical Severity Score(VCSS ). It uses a number of clinical signs, which are assigned a point equivalent depending on their severity (pain, varicose veins, edema, hyperpigmentation, inflammation, induration, the number of ulcers, the presence of active ulcers, the use of compression therapy). The sum of points reflects the severity of the pathology: the more points, the more severe the course of chronic venous disease. Changing the amount of points over time allows you to assess the degree of disease progression or the effectiveness of treatment measures. | 6 months |
| The Mean Changes VCSS for Inflammation (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale | Was used four-point scale the Venous Clinical Severity Score(VCSS ). It uses a number of clinical signs, which are assigned a point equivalent depending on their severity (pain, varicose veins, edema, hyperpigmentation, inflammation, induration, the number of ulcers, the presence of active ulcers, the use of compression therapy). The sum of points reflects the severity of the pathology: the more points, the more severe the course of chronic venous disease. Changing the amount of points over time allows you to assess the degree of disease progression or the effectiveness of treatment measures. | 6 months |
| Outcome Measure Title: The Mean Changes VCSS for Subcutaneous Tissue Induration (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale | Was used four-point scale the Venous Clinical Severity Score(VCSS ). It uses a number of clinical signs, which are assigned a point equivalent depending on their severity (pain, varicose veins, edema, hyperpigmentation, inflammation, induration, the number of ulcers, the presence of active ulcers, the use of compression therapy). The sum of points reflects the severity of the pathology: the more points, the more severe the course of chronic venous disease. Changing the amount of points over time allows you to assess the degree of disease progression or the effectiveness of treatment measures. | 6 months |
| The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). -Skin Tightening | Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine." Visual analogue scale technique: The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his symptom intensity. The ruler measures the distance (mm) between "no symptom" and "the worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity. | 6 months |
| The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Intensity of Burning Sensation | Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine." Visual analogue scale technique: The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his symptom intensity. The ruler measures the distance (mm) between "no symptom" and "the worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity. | 6 months |
| The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Skin Itching | Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine." Visual analogue scale technique: The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his symptom intensity. The ruler measures the distance (mm) between "no symptom" and "the worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity. | 6 months |
| The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Pain | Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine." Visual analogue scale technique: The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his symptom intensity. The ruler measures the distance (mm) between "no symptom" and "the worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity. | 6 months |
| The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Exudation | Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine." Visual analogue scale technique: The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his symptom intensity. The ruler measures the distance (mm) between "no symptom" and "the worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity. | 6 months |
| The Mean Changes of Global Index CIVIQ-14 Score (GIS) Between the Visit 3 and Baseline Evaluated | CIVIQ-14 - Chronic Venous Insufficiency Questionnaire (CIVIQ-14) is a specific questionnaire for venous disease. It was used to evaluate the changes in the quality of life (global index score - GIS) There are 14 questions in the CIVIQ-14, each with 5 possible answers (1 to 5), the minimum possible score being 14 and the maximum 70. In order to calculate the GIS, the difference between the final score and the minimum possible score is to be divided by the difference between the theoretical maximum and minimum scores (70-14=56), multiplied by 100. GIS = ([Final score - minimal possible score] / [Theoretical maximal - minimal score]) x 100 GIS = ([Final score - minimal possible score] / 56) x 100 GIS = ([Final score - 14] / 56) x 100 The least GIS corresponds with the best quality of life, the largest GIS corresponds with the worst. | 6 months |
| The Mean Lesion Area Changes Between the Visit 3 and Baseline Evaluated by Curvimetry Technique | This technique was used in only in Selected Centers That Use This Technique Routinely: technique is measured length of the border of modified skin, using a measuring device called a curvimetr. The quality of treatment is assessed by comparing data on Visit 0 and Visit 3 Measurements are carried out 2 times on Visit 0 and Visit 3 (before and after the treatment) in patients with skin changes of CEAP class C4a or C4b A decrease in the figure value (in centimeters) on Visit 3 vs baseline means a good treatment result. | 6 months |
| The Mean Changes of the Skin Density Determined by Durometry Technique Between the Visit 3 and Baseline Evaluated. | Shore Hardness scales is a scale for measuring the hardness of different materials.Total score has a range from 0 (the softest material) to 100 scores (the hardest material). Measurement was performed by Shore durometer (a device for measuring the hardness of a material). The method and scale were proposed by Albert F. Shore. This technique was used in only in Selected Centers That Use This Technique Routinely: technique: repeated measures to compare the scores before and after the treatment. Shore hardness is one of the methods for measuring the hardness of materials. In medicine, it is used to determine the density of the skin. In this study, the method was used to determine the density of the skin in the area of skin lesions in patients with CVD stage C4 (CEAP) | 6 months |
| Bogachev V, Boldin B, Turkin P, Samenkov A, Dzhenina O. Micronized purified flavonoid fraction-based conservative treatment of chronic venous disease in a real-world setting. Future Cardiol. 2022 Sep;18(10):777-785. doi: 10.2217/fca-2022-0026. Epub 2022 Aug 25. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| Region of Enrollment | Number | participants |
|
| Patients with chronic venous diseases of CEAP classes C4a and C4b in real clinical practice | Count of Participants | Participants |
|
|
|
| Secondary | The Mean Changes VCSS for Pain (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale | Was used four-point scale the Venous Clinical Severity Score(VCSS ). It uses a number of clinical signs, which are assigned a point equivalent depending on their severity (pain, varicose veins, edema, hyperpigmentation, inflammation, induration, the number of ulcers, the presence of active ulcers, the use of compression therapy). The sum of points reflects the severity of the pathology: the more points, the more severe the course of chronic venous disease. Changing the amount of points over time allows you to assess the degree of disease progression or the effectiveness of treatment measures. | Posted | Mean | Standard Deviation | point on scale | 6 months |
|
|
|
| Secondary | The Mean Changes VCSS for Hyperpigmentation (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale | Was used four-point scale the Venous Clinical Severity Score(VCSS ). It uses a number of clinical signs, which are assigned a point equivalent depending on their severity (pain, varicose veins, edema, hyperpigmentation, inflammation, induration, the number of ulcers, the presence of active ulcers, the use of compression therapy). The sum of points reflects the severity of the pathology: the more points, the more severe the course of chronic venous disease. Changing the amount of points over time allows you to assess the degree of disease progression or the effectiveness of treatment measures. | Posted | Mean | Standard Deviation | point on scale | 6 months |
|
|
|
| Secondary | The Mean Changes VCSS for Inflammation (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale | Was used four-point scale the Venous Clinical Severity Score(VCSS ). It uses a number of clinical signs, which are assigned a point equivalent depending on their severity (pain, varicose veins, edema, hyperpigmentation, inflammation, induration, the number of ulcers, the presence of active ulcers, the use of compression therapy). The sum of points reflects the severity of the pathology: the more points, the more severe the course of chronic venous disease. Changing the amount of points over time allows you to assess the degree of disease progression or the effectiveness of treatment measures. | Posted | Mean | Standard Deviation | point on scale | 6 months |
|
|
|
| Secondary | Outcome Measure Title: The Mean Changes VCSS for Subcutaneous Tissue Induration (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale | Was used four-point scale the Venous Clinical Severity Score(VCSS ). It uses a number of clinical signs, which are assigned a point equivalent depending on their severity (pain, varicose veins, edema, hyperpigmentation, inflammation, induration, the number of ulcers, the presence of active ulcers, the use of compression therapy). The sum of points reflects the severity of the pathology: the more points, the more severe the course of chronic venous disease. Changing the amount of points over time allows you to assess the degree of disease progression or the effectiveness of treatment measures. | Posted | Mean | Standard Deviation | point on scale | 6 months |
|
|
|
| Secondary | The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). -Skin Tightening | Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine." Visual analogue scale technique: The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his symptom intensity. The ruler measures the distance (mm) between "no symptom" and "the worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity. | Posted | Mean | Standard Deviation | point on scale | 6 months |
|
|
|
| Secondary | The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Intensity of Burning Sensation | Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine." Visual analogue scale technique: The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his symptom intensity. The ruler measures the distance (mm) between "no symptom" and "the worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity. | Posted | Mean | Standard Deviation | point on scale | 6 months |
|
|
|
| Secondary | The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Skin Itching | Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine." Visual analogue scale technique: The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his symptom intensity. The ruler measures the distance (mm) between "no symptom" and "the worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity. | Posted | Mean | Standard Deviation | point on a scale | 6 months |
|
|
|
| Secondary | The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Pain | Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine." Visual analogue scale technique: The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his symptom intensity. The ruler measures the distance (mm) between "no symptom" and "the worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity. | Posted | Mean | Standard Deviation | point on a scale | 6 months |
|
|
|
| Secondary | The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Exudation | Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine." Visual analogue scale technique: The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his symptom intensity. The ruler measures the distance (mm) between "no symptom" and "the worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity. | Posted | Mean | Standard Deviation | point on a scale | 6 months |
|
|
|
| Secondary | The Mean Changes of Global Index CIVIQ-14 Score (GIS) Between the Visit 3 and Baseline Evaluated | CIVIQ-14 - Chronic Venous Insufficiency Questionnaire (CIVIQ-14) is a specific questionnaire for venous disease. It was used to evaluate the changes in the quality of life (global index score - GIS) There are 14 questions in the CIVIQ-14, each with 5 possible answers (1 to 5), the minimum possible score being 14 and the maximum 70. In order to calculate the GIS, the difference between the final score and the minimum possible score is to be divided by the difference between the theoretical maximum and minimum scores (70-14=56), multiplied by 100. GIS = ([Final score - minimal possible score] / [Theoretical maximal - minimal score]) x 100 GIS = ([Final score - minimal possible score] / 56) x 100 GIS = ([Final score - 14] / 56) x 100 The least GIS corresponds with the best quality of life, the largest GIS corresponds with the worst. | Posted | Mean | Standard Deviation | Global Index CIVIQ-14 Score | 6 months |
|
|
|
| Secondary | The Mean Lesion Area Changes Between the Visit 3 and Baseline Evaluated by Curvimetry Technique | This technique was used in only in Selected Centers That Use This Technique Routinely: technique is measured length of the border of modified skin, using a measuring device called a curvimetr. The quality of treatment is assessed by comparing data on Visit 0 and Visit 3 Measurements are carried out 2 times on Visit 0 and Visit 3 (before and after the treatment) in patients with skin changes of CEAP class C4a or C4b A decrease in the figure value (in centimeters) on Visit 3 vs baseline means a good treatment result. | Posted | Mean | Standard Deviation | centimeter | 6 months |
|
|
|
| Secondary | The Mean Changes of the Skin Density Determined by Durometry Technique Between the Visit 3 and Baseline Evaluated. | Shore Hardness scales is a scale for measuring the hardness of different materials.Total score has a range from 0 (the softest material) to 100 scores (the hardest material). Measurement was performed by Shore durometer (a device for measuring the hardness of a material). The method and scale were proposed by Albert F. Shore. This technique was used in only in Selected Centers That Use This Technique Routinely: technique: repeated measures to compare the scores before and after the treatment. Shore hardness is one of the methods for measuring the hardness of materials. In medicine, it is used to determine the density of the skin. In this study, the method was used to determine the density of the skin in the area of skin lesions in patients with CVD stage C4 (CEAP) | Posted | Mean | Standard Deviation | scores on a scale | 6 months |
|
|
|
| 0 |
| 381 |
| 0 |
| 381 |
| 0 |
| 381 |
Not provided
Not provided