{
    "info": {
        "nct_id": "NCT06089382",
        "official_title": "A Phase III Trial of Sintilimab Plus Lenvatinib in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection",
        "inclusion_criteria": "* Subjects with a histopathological diagnosis of HCC\n* Undergone a curative resection\n* Pathologically confirmed HCC with portal vein tumor thrombus (PVTT)\n* Aged 18-75 years\n* No previous systematic treatment and locoregional therapy for HCC prior to randomization\n* No extrahepatic spread\n* Full recovery from Curative resection within 4 weeks prior to randomization\n* Child-Pugh: Grade A or B(7)\n* ECOG-PS score: 0 or 1\n* Adequate organ function\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC\n* Any preoperative treatment for HCC including local and systemic therapy\n* Have received more than 1 cycle of adjuvant TACE following surgical resection\n* Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency\n* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug\n* Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy\n* Active or history of autoimmune disease\n* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment\n* Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months\n* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment\n* Inability or refusal to comply with the treatment and monitoring",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Subjects with a histopathological diagnosis of HCC",
                "criterions": [
                    {
                        "exact_snippets": "histopathological diagnosis of HCC",
                        "criterion": "HCC diagnosis",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "histopathological"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "histopathological diagnosis of HCC",
                        "criterion": "HCC diagnosis",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "histopathological"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Undergone a curative resection",
                "criterions": [
                    {
                        "exact_snippets": "Undergone a curative resection",
                        "criterion": "curative resection",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Undergone a curative resection",
                        "criterion": "curative resection",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pathologically confirmed HCC with portal vein tumor thrombus (PVTT)",
                "criterions": [
                    {
                        "exact_snippets": "Pathologically confirmed HCC",
                        "criterion": "HCC",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "portal vein tumor thrombus (PVTT)",
                        "criterion": "portal vein tumor thrombus",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Pathologically confirmed HCC",
                        "criterion": "HCC",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "portal vein tumor thrombus (PVTT)",
                        "criterion": "portal vein tumor thrombus",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Aged 18-75 years",
                "criterions": [
                    {
                        "exact_snippets": "Aged 18-75 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Aged 18-75 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No previous systematic treatment and locoregional therapy for HCC prior to randomization",
                "criterions": [
                    {
                        "exact_snippets": "No previous systematic treatment",
                        "criterion": "previous systematic treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "locoregional therapy for HCC prior to randomization",
                        "criterion": "locoregional therapy for HCC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No previous systematic treatment",
                        "criterion": "previous systematic treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "locoregional therapy for HCC prior to randomization",
                        "criterion": "locoregional therapy for HCC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No extrahepatic spread",
                "criterions": [
                    {
                        "exact_snippets": "No extrahepatic spread",
                        "criterion": "extrahepatic spread",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No extrahepatic spread",
                        "criterion": "extrahepatic spread",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Full recovery from Curative resection within 4 weeks prior to randomization",
                "criterions": [
                    {
                        "exact_snippets": "Full recovery from Curative resection",
                        "criterion": "recovery from curative resection",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "full"
                        }
                    },
                    {
                        "exact_snippets": "within 4 weeks prior to randomization",
                        "criterion": "time since curative resection",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Full recovery from Curative resection",
                        "criterion": "recovery from curative resection",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "full"
                        }
                    },
                    {
                        "exact_snippets": "within 4 weeks prior to randomization",
                        "criterion": "time since curative resection",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate organ function",
                "criterions": [
                    {
                        "exact_snippets": "Adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
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                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC",
                "criterions": [
                    {
                        "exact_snippets": "Known fibrolamellar HCC",
                        "criterion": "fibrolamellar HCC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "sarcomatoid HCC",
                        "criterion": "sarcomatoid HCC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "mixed cholangiocarcinom",
                        "criterion": "mixed cholangiocarcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "recurrent HCC",
                        "criterion": "recurrent HCC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Known fibrolamellar HCC",
                        "criterion": "fibrolamellar HCC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "sarcomatoid HCC",
                        "criterion": "sarcomatoid HCC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "mixed cholangiocarcinom",
                        "criterion": "mixed cholangiocarcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "recurrent HCC",
                        "criterion": "recurrent HCC",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any preoperative treatment for HCC including local and systemic therapy",
                "criterions": [
                    {
                        "exact_snippets": "Any preoperative treatment for HCC including local and systemic therapy",
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                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    "criterion": "preoperative treatment for HCC",
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                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Have received more than 1 cycle of adjuvant TACE following surgical resection",
                "criterions": [
                    {
                        "exact_snippets": "received more than 1 cycle of adjuvant TACE",
                        "criterion": "adjuvant TACE cycles",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "cycle"
                            }
                        }
                    },
                    {
                        "exact_snippets": "following surgical resection",
                        "criterion": "surgical resection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "received more than 1 cycle of adjuvant TACE",
                        "criterion": "adjuvant TACE cycles",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "cycle"
                            }
                        }
                    },
                    {
                        "exact_snippets": "following surgical resection",
                        "criterion": "surgical resection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency",
                "criterions": [
                    {
                        "exact_snippets": "acute active infectious diseases",
                        "criterion": "acute active infectious diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "active or history of autoimmune disease",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "immune deficiency",
                        "criterion": "immune deficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "acute active infectious diseases",
                                "criterion": "acute active infectious diseases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "active or history of autoimmune disease",
                                "criterion": "autoimmune disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "immune deficiency",
                        "criterion": "immune deficiency",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug",
                "criterions": [
                    {
                        "exact_snippets": "Known history of serious allergy to any monoclonal antibody",
                        "criterion": "serious allergy to monoclonal antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known history of serious allergy to any ... targeted anti-angiogenic drug",
                        "criterion": "serious allergy to targeted anti-angiogenic drug",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Known history of serious allergy to any monoclonal antibody",
                        "criterion": "serious allergy to monoclonal antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known history of serious allergy to any ... targeted anti-angiogenic drug",
                        "criterion": "serious allergy to targeted anti-angiogenic drug",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy",
                "criterions": [
                    {
                        "exact_snippets": "inadequately controlled hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "inadequately controlled"
                        }
                    },
                    {
                        "exact_snippets": "history of hypertensive crisis",
                        "criterion": "hypertensive crisis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of ... hypertensive encephalopathy",
                        "criterion": "hypertensive encephalopathy",
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                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "inadequately controlled hypertension",
                                "criterion": "hypertension",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": "inadequately controlled"
                                }
                            }
                        ]
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                    {
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                            {
                                "exact_snippets": "history of hypertensive crisis",
                                "criterion": "hypertensive crisis",
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                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "history of ... hypertensive encephalopathy",
                                "criterion": "hypertensive encephalopathy",
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                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
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                "criterions": [
                    {
                        "exact_snippets": "Active or history of autoimmune disease",
                        "criterion": "autoimmune disease",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Active or history of autoimmune disease",
                        "criterion": "autoimmune disease",
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                            "expected_value": true
                        }
                    }
                ]
            },
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                        "exact_snippets": "Active or history of autoimmune disease",
                        "criterion": "autoimmune disease",
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                            "expected_value": true
                        }
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                    {
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                        "criterion": "autoimmune disease",
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment",
                "criterions": [
                    {
                        "exact_snippets": "Thrombosis or thromboembolic event within 6 months prior to the start of study treatment",
                        "criterion": "thrombosis or thromboembolic event",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    "exact_snippets": "Thrombosis or thromboembolic event within 6 months prior to the start of study treatment",
                    "criterion": "thrombosis or thromboembolic event",
                    "requirement": {
                        "requirement_type": "time frame",
                        "expected_value": {
                            "operator": "<=",
                            "value": 6,
                            "unit": "months"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months",
                "criterions": [
                    {
                        "exact_snippets": "Any persistent serious surgery-related complications",
                        "criterion": "surgery-related complications",
                        "requirement": {
                            "requirement_type": "persistence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Any persistent serious surgery-related complications",
                        "criterion": "surgery-related complications",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "esophageal and/or gastric variceal bleeding within 6 months",
                        "criterion": "esophageal and/or gastric variceal bleeding",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any persistent serious surgery-related complications",
                                "criterion": "surgery-related complications",
                                "requirement": {
                                    "requirement_type": "persistence",
                                    "expected_value": true
                                }
                            },
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                                "exact_snippets": "Any persistent serious surgery-related complications",
                                "criterion": "surgery-related complications",
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                                    "requirement_type": "severity",
                                    "expected_value": "serious"
                                }
                            }
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                            "requirement_type": "time frame",
                            "expected_value": "within 6 months"
                        }
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            }
        },
        {
            "identified_line": {
                "line": "* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment",
                "criterions": [
                    {
                        "exact_snippets": "Abdominal fistula ... within 6 months prior to the start of study treatment",
                        "criterion": "abdominal fistula",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "gastrointestinal perforation ... within 6 months prior to the start of study treatment",
                        "criterion": "gastrointestinal perforation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "intraperitoneal abscess within 6 months prior to the start of study treatment",
                        "criterion": "intraperitoneal abscess",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
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                    {
                        "exact_snippets": "Abdominal fistula ... within 6 months prior to the start of study treatment",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "gastrointestinal perforation ... within 6 months prior to the start of study treatment",
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                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "intraperitoneal abscess within 6 months prior to the start of study treatment",
                        "criterion": "intraperitoneal abscess",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
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                "criterions": [
                    {
                        "exact_snippets": "Inability ... to comply with the treatment and monitoring",
                        "criterion": "compliance with treatment and monitoring",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "refusal to comply with the treatment and monitoring",
                        "criterion": "compliance with treatment and monitoring",
                        "requirement": {
                            "requirement_type": "willingness",
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                        }
                    }
                ]
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                            }
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                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Child-Pugh: Grade A or B(7)",
                "criterions": [
                    {
                        "exact_snippets": "Child-Pugh: Grade A or B(7)",
                        "criterion": "Child-Pugh score",
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    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}