{
"info": {
"nct_id": "NCT02399033",
"official_title": "Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy: A Multicenter Randomized Controlled Trial",
"inclusion_criteria": "1. Age: 20-70 years old;\n2. Gender: male or female;\n3. clinical or pathological diagnosis of hepatocellular carcinoma (HCC) in previously untreated patients;\n4. The expected survival> 3 months;\n5. Child-Pugh grade in A-level;\n6. KPS score with 50-100 points;\n7. In two weeks after hepatectomy for R0 resection surgery. Preoperative must meet the following criteria:\n\n * BCLC stage of 0-B;\n * conform to the indications of hepatectomy;\n * Viable tumor resection confirmed by two highly qualified surgical doctors;\n * No other surgical contraindications.\n8. women in the reproductive period must be completely contraception in 28 days before treatment, during the treatment process and in 28 days after treatment;\n9. Men must be completely contraception and prohibited donation and sperm donation during the treatment process and in 28 days after treatment;\n10. All patients must be prohibited donation during the treatment process and in 28 days after treatment;\n11. In addition to the subjects, prohibitting other people taking this product.\n12. patients have a good understanding and could coordinate with investigators for the trial.\n13. Patients enrolled in the trial should sign an informed consent form, to indicate understanding the purpose and procedure of the trial, and patients volunteering to participate in the trial.\nHealthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "1. Because of suffering from any serious illness,laboratory abnormalities or mental abnormalities,the patient is unable to sign an informed consent form;\n2. patients with medical abnormalities may result in that the trial could not be evaluated or have security risks;\n3. persons who are unable to take oral drugs.\n4. coagulation dysfunction;\n5. HIV, syphilis-infected persons;\n6. persons who have a serious heart, liver and renal failure;\n7. persons who are known to allergic to the drug or any component of the drug;\n8. persons who are received experimental therapy in 28 days before the first treatment;\n9. persons who are received radiotherapy or other surgery(including of the other local surgery for cancer treatment,eg. TACE) in addition to hepatectomy in 14 days before the first treatment;\n10. lactating or pregnant women;\n11. patients in the reproductive period are unwilling or unable to contraception;\n12. persons with poor medication compliance;\n13. The researchers considered unsuitable selected patients.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Age: 20-70 years old;",
"criterions": [
{
"exact_snippets": [
"Age: 20-70 years old"
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 20
},
{
"operator": "<=",
"value": 70
}
]
}
}
]
},
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{
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"Age: 20-70 years old"
],
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{
"operator": ">=",
"value": 20
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"value": 70
}
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}
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]
}
},
{
"identified_line": {
"line": "2. Gender: male or female;",
"criterions": [
{
"exact_snippets": [
"Gender: male or female"
],
"criterion": "gender",
"requirement_type": "N/A",
"expected_value": [
"male",
"female"
]
}
]
},
"logical_structure": {
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"Gender: male or female"
],
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"requirement_type": "N/A",
"expected_value": "male"
},
{
"exact_snippets": [
"Gender: male or female"
],
"criterion": "gender",
"requirement_type": "N/A",
"expected_value": "female"
}
]
}
},
{
"identified_line": {
"line": "3. clinical or pathological diagnosis of hepatocellular carcinoma (HCC) in previously untreated patients;",
"criterions": [
{
"exact_snippets": [
"clinical or pathological diagnosis of hepatocellular carcinoma (HCC)"
],
"criterion": "hepatocellular carcinoma (HCC)",
"requirement_type": "diagnosis",
"expected_value": true
},
{
"exact_snippets": [
"previously untreated patients"
],
"criterion": "treatment history",
"requirement_type": "status",
"expected_value": "untreated"
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"clinical or pathological diagnosis of hepatocellular carcinoma (HCC)"
],
"criterion": "hepatocellular carcinoma (HCC)",
"requirement_type": "diagnosis",
"expected_value": true
},
{
"exact_snippets": [
"previously untreated patients"
],
"criterion": "treatment history",
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"expected_value": "untreated"
}
]
}
},
{
"identified_line": {
"line": "4. The expected survival> 3 months;",
"criterions": [
{
"exact_snippets": [
"expected survival> 3 months"
],
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"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3
}
}
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"expected survival> 3 months"
],
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"operator": ">",
"value": 3
}
}
]
}
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{
"identified_line": {
"line": "5. Child-Pugh grade in A-level;",
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{
"exact_snippets": [
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"A-level"
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"expected_value": "A"
}
]
},
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"exact_snippets": [
"Child-Pugh grade",
"A-level"
],
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"requirement_type": "level",
"expected_value": "A"
}
]
}
},
{
"identified_line": {
"line": "6. KPS score with 50-100 points;",
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{
"exact_snippets": [
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"requirement_type": "range",
"expected_value": {
"comparisons": [
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"operator": ">=",
"value": 50
},
{
"operator": "<=",
"value": 100
}
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}
}
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"50-100 points"
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"operator": ">=",
"value": 50
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{
"identified_line": {
"line": "7. In two weeks after hepatectomy for R0 resection surgery. Preoperative must meet the following criteria:",
"criterions": [
{
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"two weeks after hepatectomy"
],
"criterion": "time since hepatectomy",
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"operator": ">=",
"value": 2
}
},
{
"exact_snippets": [
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],
"criterion": "resection surgery type",
"requirement_type": "type",
"expected_value": "R0"
}
]
},
"logical_structure": {
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{
"exact_snippets": [
"two weeks after hepatectomy"
],
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"operator": ">=",
"value": 2
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},
{
"exact_snippets": [
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"expected_value": "R0"
}
]
}
},
{
"identified_line": {
"line": "* BCLC stage of 0-B;",
"criterions": [
{
"exact_snippets": [
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],
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"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0
},
{
"operator": "<=",
"value": 1
}
]
}
}
]
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],
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"operator": ">=",
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},
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}
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}
},
{
"identified_line": {
"line": "* conform to the indications of hepatectomy;",
"criterions": [
{
"exact_snippets": [
"conform to the indications of hepatectomy"
],
"criterion": "hepatectomy indications",
"requirement_type": "conformance",
"expected_value": true
}
]
},
"logical_structure": {
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"exact_snippets": [
"conform to the indications of hepatectomy"
],
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},
{
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"line": "* Viable tumor resection confirmed by two highly qualified surgical doctors;",
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{
"exact_snippets": [
"Viable tumor resection confirmed"
],
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"expected_value": true
},
{
"exact_snippets": [
"confirmed by two highly qualified surgical doctors"
],
"criterion": "confirmation by surgical doctors",
"requirement_type": "quantity",
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}
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],
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{
"exact_snippets": [
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{
"identified_line": {
"line": "* No other surgical contraindications.",
"criterions": [
{
"exact_snippets": [
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],
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"expected_value": false
}
]
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],
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}
]
}
},
{
"identified_line": {
"line": "8. women in the reproductive period must be completely contraception in 28 days before treatment, during the treatment process and in 28 days after treatment;",
"criterions": [
{
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],
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"requirement_type": "specific group",
"expected_value": "women in the reproductive period"
},
{
"exact_snippets": [
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],
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},
{
"exact_snippets": [
"28 days before treatment"
],
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"requirement_type": "duration before treatment",
"expected_value": true
},
{
"exact_snippets": [
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],
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},
{
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}
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},
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"else_criteria": null
}
},
{
"identified_line": {
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{
"exact_snippets": [
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],
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"expected_value": true
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{
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"criterions": [
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}
},
{
"identified_line": {
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{
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}
},
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"identified_line": {
"line": "12. patients have a good understanding and could coordinate with investigators for the trial.",
"criterions": [
{
"exact_snippets": [
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],
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"requirement_type": "quality",
"expected_value": "good"
},
{
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"requirement_type": "ability",
"expected_value": true
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{
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}
},
{
"identified_line": {
"line": "13. Patients enrolled in the trial should sign an informed consent form, to indicate understanding the purpose and procedure of the trial, and patients volunteering to participate in the trial.",
"criterions": [
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],
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"requirement_type": "signature",
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},
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}
},
{
"identified_line": {
"line": "Must have minimum age of 20 Years",
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"exact_snippets": [
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}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 70 Years",
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"exact_snippets": [
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}
}
],
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{
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"line": "1. Because of suffering from any serious illness,laboratory abnormalities or mental abnormalities,the patient is unable to sign an informed consent form;",
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{
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{
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{
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}
]
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}
}
},
{
"identified_line": {
"line": "3. persons who are unable to take oral drugs.",
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{
"exact_snippets": [
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}
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},
{
"identified_line": {
"line": "4. coagulation dysfunction;",
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{
"exact_snippets": [
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"expected_value": true
}
]
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"coagulation dysfunction"
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}
}
},
{
"identified_line": {
"line": "5. HIV, syphilis-infected persons;",
"criterions": [
{
"exact_snippets": [
"HIV"
],
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"expected_value": true
},
{
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}
]
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},
{
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],
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}
]
}
},
{
"identified_line": {
"line": "6. persons who have a serious heart, liver and renal failure;",
"criterions": [
{
"exact_snippets": [
"serious heart"
],
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"requirement_type": "severity",
"expected_value": "serious"
},
{
"exact_snippets": [
"serious",
"liver"
],
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},
{
"exact_snippets": [
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],
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]
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{
"exact_snippets": [
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],
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]
}
},
{
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],
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"requirement_type": "presence",
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},
{
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"requirement_type": "presence",
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}
]
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}
]
}
},
{
"identified_line": {
"line": "8. persons who are received experimental therapy in 28 days before the first treatment;",
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{
"exact_snippets": [
"received experimental therapy in 28 days before the first treatment"
],
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"requirement_type": "recency",
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"operator": "<=",
"value": 28
}
]
}
}
]
},
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"operator": "<=",
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}
]
}
}
}
},
{
"identified_line": {
"line": "9. persons who are received radiotherapy or other surgery(including of the other local surgery for cancer treatment,eg. TACE) in addition to hepatectomy in 14 days before the first treatment;",
"criterions": [
{
"exact_snippets": [
"received radiotherapy"
],
"criterion": "radiotherapy",
"requirement_type": "receipt",
"expected_value": true
},
{
"exact_snippets": [
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],
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"requirement_type": "receipt",
"expected_value": true
},
{
"exact_snippets": [
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],
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"requirement_type": "receipt",
"expected_value": true
},
{
"exact_snippets": [
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"requirement_type": "receipt",
"expected_value": true
},
{
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],
"criterion": "hepatectomy",
"requirement_type": "receipt",
"expected_value": true
},
{
"exact_snippets": [
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],
"criterion": "time since treatment",
"requirement_type": "duration",
"expected_value": {
"comparisons": [
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"operator": "<=",
"value": 14
}
]
}
}
]
},
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},
{
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],
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"operator": "<=",
"value": 14
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]
}
}
]
},
{
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],
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},
{
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],
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},
{
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],
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},
{
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],
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"operator": "<=",
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}
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},
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},
{
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],
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"operator": "<=",
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}
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},
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}
]
}
},
{
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{
"exact_snippets": [
"lactating"
],
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"requirement_type": "status",
"expected_value": false
},
{
"exact_snippets": [
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],
"criterion": "pregnancy",
"requirement_type": "status",
"expected_value": false
}
]
},
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},
{
"exact_snippets": [
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],
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"requirement_type": "status",
"expected_value": false
}
]
}
},
{
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{
"exact_snippets": [
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"requirement_type": "status",
"expected_value": true
},
{
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"expected_value": true
}
]
},
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]
},
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}
},
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}
},
{
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],
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}
]
},
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}
}
},
{
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}
]
},
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}
}
}
],
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"failed_exclusion": [],
"failed_miscellaneous": []
}