{
"info": {
"nct_id": "NCT00093548",
"official_title": "A Phase I/II Trial Testing Immunization With AFP + GM-CSF Plasmid Prime And AFP Adenoviral Vector Boost In Patients With Hepatocellular Carcinoma (AFP Prime-Boost Protocol)",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of hepatocellular carcinoma\n\n * Stage II-IVA disease\n\n * No active disease after local or regional therapy (e.g., surgical resection, radiofrequency ablation, cryoablation, or ethanol injection)\n* Serum alpha fetoprotein > upper limit of normal\n* HLA-A*0201 positive by DNA subtyping\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Hemoglobin > 9.0 g/dL (transfusion independent)\n* Platelet count > 50,000/mm^3\n* Absolute neutrophil count > 1,000/mm^3\n\nHepatic\n\n* Child Pugh class A or B liver function\n* Hepatitis B or C viral infection allowed\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* No New York Heart Association class III or IV cardiac insufficiency\n* No coronary artery disease\n\nImmunologic\n\n* HIV negative\n* No other acute viral, bacterial, or fungal infection requiring therapy\n* No allergy to study agents\n* No history of opportunistic infection\n* No high serum titer of neutralizing anti-adenoviral antibodies\n* No congenital or acquired condition resulting in an inability to generate an immune response\n\nOther\n\n* Not pregnant\n* Negative pregnancy test\n* Fertile patients must use effective double-method (including a barrier method) contraception\n* No other condition that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* At least 30 days since prior chemotherapy\n* No concurrent cytotoxic chemotherapy\n\nEndocrine therapy\n\n* At least 30 days since prior steroid therapy\n* No concurrent steroid therapy, including corticosteroids\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* See Disease Characteristics\n* No prior organ allograft\n\nOther\n\n* At least 2 weeks since prior therapy for acute infection\n* No concurrent immunosuppressive therapy\n* No concurrent cyclosporine"
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
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{
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"expected_value": "healthy"
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Healthy volunteers allowed",
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
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{
"exact_snippets": "minimum age of 18 Years",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
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"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "DISEASE CHARACTERISTICS:",
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{
"exact_snippets": "DISEASE CHARACTERISTICS",
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"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
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"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* Diagnosis of hepatocellular carcinoma",
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{
"exact_snippets": "Diagnosis of hepatocellular carcinoma",
"criterion": "hepatocellular carcinoma",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Diagnosis of hepatocellular carcinoma",
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}
}
]
}
},
{
"identified_line": {
"line": "* Stage II-IVA disease",
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{
"exact_snippets": "Stage II-IVA disease",
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "stage"
},
{
"operator": "<=",
"value": 4,
"unit": "stage"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Stage II-IVA disease",
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{
"operator": ">=",
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},
{
"operator": "<=",
"value": 4,
"unit": "stage"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* No active disease after local or regional therapy (e.g., surgical resection, radiofrequency ablation, cryoablation, or ethanol injection)",
"criterions": [
{
"exact_snippets": "No active disease after local or regional therapy",
"criterion": "active disease",
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}
},
{
"exact_snippets": "local or regional therapy (e.g., surgical resection, radiofrequency ablation, cryoablation, or ethanol injection)",
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},
"logical_structure": {
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}
},
{
"exact_snippets": "local or regional therapy (e.g., surgical resection, radiofrequency ablation, cryoablation, or ethanol injection)",
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}
}
]
}
},
{
"identified_line": {
"line": "* Serum alpha fetoprotein > upper limit of normal",
"criterions": [
{
"exact_snippets": "Serum alpha fetoprotein > upper limit of normal",
"criterion": "serum alpha fetoprotein",
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"requirement_type": "level",
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"operator": ">",
"value": 1,
"unit": "ULN"
}
}
}
]
},
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"exact_snippets": "Serum alpha fetoprotein > upper limit of normal",
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"operator": ">",
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"unit": "ULN"
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}
}
]
}
},
{
"identified_line": {
"line": "* HLA-A*0201 positive by DNA subtyping",
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{
"exact_snippets": "HLA-A*0201 positive by DNA subtyping",
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"requirement": {
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"expected_value": "positive"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "HLA-A*0201 positive by DNA subtyping",
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}
}
]
}
},
{
"identified_line": {
"line": "Age",
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{
"exact_snippets": "Age",
"criterion": "age",
"requirement": {
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"expected_value": "N/A"
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Age",
"criterion": "age",
"requirement": {
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"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* Over 18",
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{
"exact_snippets": "Over 18",
"criterion": "age",
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"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Over 18",
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"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Performance status",
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{
"exact_snippets": "Performance status",
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"expected_value": "N/A"
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Performance status",
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}
}
]
}
},
{
"identified_line": {
"line": "* Karnofsky 70-100%",
"criterions": [
{
"exact_snippets": "Karnofsky 70-100%",
"criterion": "Karnofsky performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 70,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Karnofsky 70-100%",
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{
"operator": ">=",
"value": 70,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "Life expectancy",
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{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
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"expected_value": "N/A"
}
}
]
},
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"exact_snippets": "Life expectancy",
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic",
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"expected_value": true
}
}
]
},
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{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic",
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}
}
]
}
},
{
"identified_line": {
"line": "* Hemoglobin > 9.0 g/dL (transfusion independent)",
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{
"exact_snippets": "Hemoglobin > 9.0 g/dL",
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"operator": ">",
"value": 9.0,
"unit": "g/dL"
}
}
},
{
"exact_snippets": "transfusion independent",
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"requirement_type": "independence",
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}
}
]
},
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"exact_snippets": "Hemoglobin > 9.0 g/dL",
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"operator": ">",
"value": 9.0,
"unit": "g/dL"
}
}
},
{
"exact_snippets": "transfusion independent",
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}
}
]
}
},
{
"identified_line": {
"line": "* Platelet count > 50,000/mm^3",
"criterions": [
{
"exact_snippets": "Platelet count > 50,000/mm^3",
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"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 50000,
"unit": "mm^3"
}
}
}
]
},
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{
"exact_snippets": "Platelet count > 50,000/mm^3",
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},
{
"identified_line": {
"line": "* Absolute neutrophil count > 1,000/mm^3",
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{
"exact_snippets": "Absolute neutrophil count > 1,000/mm^3",
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"operator": ">",
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"unit": "mm^3"
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}
}
]
},
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{
"exact_snippets": "Absolute neutrophil count > 1,000/mm^3",
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}
}
}
]
}
},
{
"identified_line": {
"line": "Hepatic",
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{
"exact_snippets": "Hepatic",
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"expected_value": "N/A"
}
}
]
},
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"exact_snippets": "Hepatic",
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}
]
}
},
{
"identified_line": {
"line": "* Hepatitis B or C viral infection allowed",
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}
},
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"exact_snippets": "Hepatitis B or C viral infection allowed",
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}
}
]
},
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"exact_snippets": "Hepatitis B or C viral infection allowed",
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}
},
{
"exact_snippets": "Hepatitis B or C viral infection allowed",
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}
]
}
},
{
"identified_line": {
"line": "Renal",
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{
"exact_snippets": "Renal",
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Renal",
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}
}
]
}
},
{
"identified_line": {
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}
}
]
},
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"exact_snippets": "Cardiovascular",
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}
}
]
}
},
{
"identified_line": {
"line": "* No New York Heart Association class III or IV cardiac insufficiency",
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{
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"requirement": {
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"unit": "class"
}
}
}
]
},
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"unit": "class"
}
}
}
}
},
{
"identified_line": {
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"exact_snippets": "Immunologic",
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}
}
]
},
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"exact_snippets": "Immunologic",
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}
]
}
},
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}
}
]
},
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"exact_snippets": "HIV negative",
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "No other acute viral ... infection requiring therapy",
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}
},
{
"exact_snippets": "No other ... bacterial ... infection requiring therapy",
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}
},
{
"exact_snippets": "No other ... fungal infection requiring therapy",
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}
}
]
},
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}
},
{
"exact_snippets": "No other ... bacterial ... infection requiring therapy",
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}
},
{
"exact_snippets": "No other ... fungal infection requiring therapy",
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
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}
}
]
},
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}
}
]
}
},
{
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{
"exact_snippets": "high serum titer of neutralizing anti-adenoviral antibodies",
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"value": 1,
"unit": "high"
}
}
}
]
},
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}
}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "No congenital or acquired condition resulting in an inability to generate an immune response",
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"requirement": {
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}
}
]
},
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"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Negative pregnancy test",
"criterions": [
{
"exact_snippets": "Negative pregnancy test",
"criterion": "pregnancy test",
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"requirement_type": "result",
"expected_value": "negative"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Negative pregnancy test",
"criterion": "pregnancy test",
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}
}
]
}
},
{
"identified_line": {
"line": "* Fertile patients must use effective double-method (including a barrier method) contraception",
"criterions": [
{
"exact_snippets": "Fertile patients",
"criterion": "fertility",
"requirement": {
"requirement_type": "status",
"expected_value": "fertile"
}
},
{
"exact_snippets": "must use effective double-method (including a barrier method) contraception",
"criterion": "contraception",
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"requirement_type": "method",
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}
}
]
},
"logical_structure": {
"condition": {
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"criterion": "fertility",
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"expected_value": "fertile"
}
},
"then_criteria": {
"exact_snippets": "must use effective double-method (including a barrier method) contraception",
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}
},
"else_criteria": null
}
},
{
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},
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},
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"and_criteria": []
}
},
{
"identified_line": {
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{
"identified_line": {
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}
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}
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]
}