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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002610-13 | EudraCT Number |
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The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will be in the dosing period of the study for 12 weeks in order to evaluate the incidence of hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and all 12 will receive paricalcitol capsules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol | Experimental | Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paricalcitol | Drug | Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Hypercalcemia | The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values > 10.2 mg/dL (2.55 mmol/L). | Day 1 to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL | Baseline (last measurement collected prior to the first dose) to Week 12 | |
| Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline |
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Inclusion Criteria:
Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening
Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism
For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor [VDR] Activators or those who have completed a 2 to 12 week washout), the subject must meet the following laboratory criteria prior to enrollment:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Eldred, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28332096 | Result | Webb NJA, Lerner G, Warady BA, Dell KM, Greenbaum LA, Ariceta G, Hoppe B, Linde P, Lee HJ, Eldred A, Dufek MB. Efficacy and safety of paricalcitol in children with stages 3 to 5 chronic kidney disease. Pediatr Nephrol. 2017 Jul;32(7):1221-1232. doi: 10.1007/s00467-017-3579-6. Epub 2017 Mar 22. |
| Label | URL |
|---|---|
| Prescribing Information | View source |
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A total of 26 subjects were screened and 13 pediatric subjects (between 10 and 16 years of age) were enrolled; 1 subject was 16 years of age at the time of Screening and turned 17 by the time treatment began.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol | Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline (last measurement collected prior to the first dose) to Week 12 |
| Hemoglobin: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Hematocrit: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Red Blood Cells: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit | n=subjects with evaluable Baseline and Post-baseline data for each parameter. | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | n=subjects with evaluable Baseline and Post-baseline data for each parameter. | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Alkaline Phosphatase: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Total Protein and Albumin: Mean Change From Baseline to Final Visit | n=subjects with evaluable Baseline and Post-baseline data for each parameter. | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit | n=subjects with evaluable Baseline and Post-baseline data for each parameter. | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Osteocalcin: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Number of Subjects With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section. | From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks). |
| Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings | 12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented. | Baseline (Day 1) to Final Visit (up to Week 12) |
| Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit | Blood pressure was measured after the subject had been sitting for at least 3 minutes. | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Heart Rate: Mean Change From Baseline to Final Visit | Heart rate was measured after the subject had been sitting for at least 3 minutes. | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Oral Body Temperature: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
| Number of Subjects With Potentially Clinically Significant Physical Examination Findings | Baseline (Day 1) and Final Visit (up to Week 12) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paricalcitol | Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks. |
| Units | Counts |
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| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percentage of Subjects With Hypercalcemia | The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values > 10.2 mg/dL (2.55 mmol/L). | All-treated data set: all subjects enrolled and administered at least 1 dose of paricalcitol | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to Week 12 |
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| Secondary | Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL | All-treated data set | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (last measurement collected prior to the first dose) to Week 12 |
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| Secondary | Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline | All-treated data set | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (last measurement collected prior to the first dose) to Week 12 |
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| Secondary | Hemoglobin: Mean Change From Baseline to Final Visit | All subjects in the all-treated data set with evaluable data | Posted | Mean | Standard Deviation | g/dL | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Hematocrit: Mean Change From Baseline to Final Visit | All subjects in the all-treated data set with evaluable data | Posted | Mean | Standard Deviation | percent | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Red Blood Cells: Mean Change From Baseline to Final Visit | All subjects in the all-treated data set with evaluable data | Posted | Mean | Standard Deviation | cells x 10^6/µL | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit | All subjects in the all-treated data set with evaluable data | Posted | Mean | Standard Deviation | cells x 10^3/µL | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit | All subjects in the all-treated data set with evaluable data | Posted | Mean | Standard Deviation | cells x 10^9/µL | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit | n=subjects with evaluable Baseline and Post-baseline data for each parameter. | All subjects in the all-treated data set with evaluable data | Posted | Mean | Standard Deviation | U/L | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | n=subjects with evaluable Baseline and Post-baseline data for each parameter. | All subjects in the all-treated data set with evaluable data | Posted | Mean | Standard Deviation | mg/dL | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Alkaline Phosphatase: Mean Change From Baseline to Final Visit | All subjects in the all-treated data set with evaluable data | Posted | Mean | Standard Deviation | IU/L | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit | All subjects in the all-treated data set with evaluable data | Posted | Mean | Standard Deviation | mEq/L | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Total Protein and Albumin: Mean Change From Baseline to Final Visit | n=subjects with evaluable Baseline and Post-baseline data for each parameter. | All-treated data set | Posted | Mean | Standard Deviation | g/dL | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit | n=subjects with evaluable Baseline and Post-baseline data for each parameter. | All-treated data set | Posted | Mean | Standard Deviation | pg/mL | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Osteocalcin: Mean Change From Baseline to Final Visit | All subjects in the all-treated data set with evaluable data | Posted | Mean | Standard Deviation | ng/mL | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Number of Subjects With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section. | All-treated data set | Posted | Number | participants | From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks). |
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| Secondary | Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings | 12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented. | All-treated data set | Posted | Number | participants | Baseline (Day 1) to Final Visit (up to Week 12) |
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| Secondary | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit | Blood pressure was measured after the subject had been sitting for at least 3 minutes. | All-treated data set | Posted | Mean | Standard Deviation | mm Hg | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Heart Rate: Mean Change From Baseline to Final Visit | Heart rate was measured after the subject had been sitting for at least 3 minutes. | All-treated data set | Posted | Mean | Standard Deviation | bpm | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Oral Body Temperature: Mean Change From Baseline to Final Visit | All-treated data set | Posted | Mean | Standard Deviation | degrees Celsius | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) |
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| Secondary | Number of Subjects With Potentially Clinically Significant Physical Examination Findings | All-treated data set | Posted | Number | participants | Baseline (Day 1) and Final Visit (up to Week 12) |
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Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
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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 | Paricalcitol | Open-label paricalcitol (maximum dose of 16 μg), 3 times weekly (no more frequently than every other day) for 12 weeks. | 2 | 13 | 10 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PERITONEAL DIALYSIS COMPLICATION | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| FLUID OVERLOAD | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 17.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 17.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| ARTERIOVENOUS FISTULA SITE COMPLICATION | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| PROCEDURAL VOMITING | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| BLOOD CALCIUM INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
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| HAEMOGLOBIN DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
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| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| THROAT IRRITATION | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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The sample size of the study was limited to 13 subjects and there was no comparator group, so the study was not designed to analyze efficacy.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
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