{
    "info": {
        "nct_id": "NCT06080776",
        "official_title": "A Phase III, Double-blind, Randomised Study of SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With Sensitizing EGFR Mutations",
        "inclusion_criteria": "* Male or female, aged at least 18 years, younger than 75 years.\n* Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology.\n* Before surgery or randomization, MRI or CT scan of the brain and bone scan must be done to exclude metastases.\n* Complete resection (R0) and systematic lymphadenectomy are mandatory: all surgical margins must be negative for tumor, and there should be no extranodal invasion of the mediastinal lymph nodes or marginal lymph nodes.\n* Patients with postoperative pathological confirmation of stage II, IIIA and IIIB (only T3N2M0) are eligible.\n* Patients must harbor one of the two common sensitizing EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M, the mutations should be confirmed by the central laboratory.\n* Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.\n* A ECOG performance status equal to 0-1 with a minimum life expectancy of 12 weeks and no deterioration over the past 2 weeks.\n* Adequate bone marrow reserve or organ function, as demonstrated by the following laboratory values (no corrective treatment allowed within one week before blood sampling):\n\n  1. Absolute neutrophil count (ANC）≥1.5×10^9 /L\n  2. Platelet count ≥100×10^9 /L\n  3. Hemoglobin ≥90 g/L\n  4. Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases\n  5. Aspartate aminotransferase (AST) ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases\n  6. Total bilirubin (TBL) ≤ 1.5 × ULN if no liver metastases or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases\n  7. Creatinine ≤ 1.5 × ULN concurrent with creatinine clearance ≥ 50 mL/min (measured or calculated by the Cockcroft-Gault equation); confirmation of creatinine clearance is only required when creatinine is ≤ 1.5×ULN\n  8. Serum albumin (ALB) ≥28 g/L\n  9. Coagulation function: International standardized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN\n* Females of child-bearing potential should be using adequate contraceptive measures throughout the study, should not be breast feeding during the study and until 6 months after treatment, and must have a negative pregnancy test prior to start of dosing.\n* Male patients should be willing to use barrier contraception during the study and until 6 months after treatment.\n* Patients must sign and date written informed consent prior to admission to the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Patients with unresectable or metastatic lesions, residual lesions after surgery, or those who have had only segmentectomies or wedge resection.\n* Giant mediastinal lymph node metastasis at a single station or mediastinal lymph node fusion into a cluster at multiple stations; lesions invade the heart, aorta, esophagus, or pulmonary veins; Carcinoma of superior lung sulci.\n* Treatment with any of the following (except for standard platinum -based adjuvant chemotherapy), including any EGFR-TKI, systemic chemotherapy，immunotherapy, targeted therapy and anti-tumor traditional Chinese medicine therapy.\n* Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.\n* The patient is currently using (or cannot discontinue at least 1 week before the first dose of study drug) a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.\n* Severe infections occurred within 4 weeks or active infections that received therapeutic intravenous or oral antibiotics within 2 weeks before the first dose.\n* Any evidence of active infection (including hepatitis B, hepatitis C, and human immunodeficiency virus).\n* Patients received continuous steroid therapy for more than 30 days within 30 days before the first dose; require long-term (≥30 days) steroid therapy; with acquired or congenital immunodeficiency diseases or have a history of organ transplantation.\n* Severe or uncontrolled systemic diseases, including hypertension or diabetes.\n* Any of the following cardiac criteria:\n\n  1. Mean resting corrected QT interval (QTcF) > 470 msec obtained from 3 electrocardiograms (ECGs), using the Screening clinic's ECG machine and Fridericia's formula for QT interval correction.\n  2. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250 msec).\n  3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.\n  4. Left ventricular ejection fraction (LVEF) <50%.\n* Receiving or requiring drugs known to prolong the QT interval or possibly cause tip torsion ventricular tachycardia during the study.\n* History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n* History of any other malignant tumor within five years (except clinically cured cervical carcinoma in situ, basal cells or squamous epithelial skin cancer).\n* Any seriously abnormal gastrointestinal function would affect uptake, transport and absorption of the drug, such as inability to swallow the study medication, refractory nausea and vomiting, previous significant bowel resection, Recurrent diarrhea, atrophic gastritis (age < 60 years), unhealed serious gastric diseases, Crohn's disease or ulcerative colitis.\n* History of hypersensitivity to any active or inactive ingredient of SH-1028 or drug with a similar chemical structure or class to SH-1028.\n* Any severe and uncontrolled ocular disease that may, in the Investigator's opinion, present a specific risk to the patient's safety.\n* Participating in another clinical trial within 4 weeks before the first dose (excluding retrospective observational studies without intervention); within 5 half-lives of other study drugs.\n* Hepatic encephalopathy, hepatorenal syndrome, or ≥Child-Pugh grade B cirrhosis.\n* Lactating Women.\n* Any disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology.",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC)",
                        "criterion": "primary non-small lung cancer (NSCLC)",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "predominantly non-squamous histology",
                        "criterion": "non-squamous histology",
                        "requirement": {
                            "requirement_type": "predominance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC)",
                        "criterion": "primary non-small lung cancer (NSCLC)",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "predominantly non-squamous histology",
                        "criterion": "non-squamous histology",
                        "requirement": {
                            "requirement_type": "predominance",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Before surgery or randomization, MRI or CT scan of the brain and bone scan must be done to exclude metastases.",
                "criterions": [
                    {
                        "exact_snippets": "MRI or CT scan of the brain ... must be done to exclude metastases.",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "bone scan must be done to exclude metastases.",
                        "criterion": "bone metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "MRI or CT scan of the brain ... must be done to exclude metastases.",
                                "criterion": "brain metastases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "bone scan must be done to exclude metastases.",
                                "criterion": "brain metastases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "bone scan must be done to exclude metastases.",
                        "criterion": "bone metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Complete resection (R0) and systematic lymphadenectomy are mandatory: all surgical margins must be negative for tumor, and there should be no extranodal invasion of the mediastinal lymph nodes or marginal lymph nodes.",
                "criterions": [
                    {
                        "exact_snippets": "Complete resection (R0) ... all surgical margins must be negative for tumor",
                        "criterion": "surgical margins",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "negative for tumor"
                        }
                    },
                    {
                        "exact_snippets": "systematic lymphadenectomy ... there should be no extranodal invasion of the mediastinal lymph nodes or marginal lymph nodes",
                        "criterion": "extranodal invasion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Complete resection (R0) ... all surgical margins must be negative for tumor",
                                "criterion": "surgical margins",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "negative for tumor"
                                }
                            },
                            {
                                "exact_snippets": "systematic lymphadenectomy ... there should be no extranodal invasion of the mediastinal lymph nodes or marginal lymph nodes",
                                "criterion": "extranodal invasion",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with postoperative pathological confirmation of stage II, IIIA and IIIB (only T3N2M0) are eligible.",
                "criterions": [
                    {
                        "exact_snippets": "postoperative pathological confirmation",
                        "criterion": "postoperative pathological confirmation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stage II, IIIA and IIIB (only T3N2M0)",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "allowed_stages",
                            "expected_value": [
                                "II",
                                "IIIA",
                                "IIIB (only T3N2M0)"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "postoperative pathological confirmation",
                        "criterion": "postoperative pathological confirmation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stage II, IIIA and IIIB (only T3N2M0)",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "allowed_stages",
                            "expected_value": [
                                "II",
                                "IIIA",
                                "IIIB (only T3N2M0)"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must harbor one of the two common sensitizing EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M, the mutations should be confirmed by the central laboratory.",
                "criterions": [
                    {
                        "exact_snippets": "Patients must harbor one of the two common sensitizing EGFR mutations (Ex19del, L858R)",
                        "criterion": "EGFR mutations",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "Ex19del",
                                "L858R"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "either alone or in combination with other EGFR mutations including T790M",
                        "criterion": "EGFR mutations",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "T790M"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "the mutations should be confirmed by the central laboratory",
                        "criterion": "mutation confirmation",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "central laboratory"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients must harbor one of the two common sensitizing EGFR mutations (Ex19del, L858R)",
                                        "criterion": "EGFR mutations",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": [
                                                "Ex19del",
                                                "L858R"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "either alone or in combination with other EGFR mutations including T790M",
                                        "criterion": "EGFR mutations",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": []
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients must harbor one of the two common sensitizing EGFR mutations (Ex19del, L858R)",
                                        "criterion": "EGFR mutations",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": [
                                                "Ex19del",
                                                "L858R"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "either alone or in combination with other EGFR mutations including T790M",
                                        "criterion": "EGFR mutations",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": [
                                                "T790M"
                                            ]
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "the mutations should be confirmed by the central laboratory",
                        "criterion": "mutation confirmation",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "central laboratory"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.",
                "criterions": [
                    {
                        "exact_snippets": "Complete recovery from surgery",
                        "criterion": "recovery from surgery",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "complete"
                        }
                    },
                    {
                        "exact_snippets": "Complete recovery from ... standard post-operative therapy (if applicable)",
                        "criterion": "recovery from standard post-operative therapy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "complete"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Complete recovery from surgery",
                        "criterion": "recovery from surgery",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "complete"
                        }
                    },
                    {
                        "exact_snippets": "Complete recovery from ... standard post-operative therapy (if applicable)",
                        "criterion": "recovery from standard post-operative therapy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "complete"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* A ECOG performance status equal to 0-1 with a minimum life expectancy of 12 weeks and no deterioration over the past 2 weeks.",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status equal to 0-1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "minimum life expectancy of 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "no deterioration over the past 2 weeks",
                        "criterion": "deterioration",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "ECOG performance status equal to 0-1",
                                        "criterion": "ECOG performance status",
                                        "requirement": {
                                            "requirement_type": "value",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "=",
                                                        "value": 0,
                                                        "unit": "N/A"
                                                    },
                                                    {
                                                        "operator": "=",
                                                        "value": 1,
                                                        "unit": "N/A"
                                                    }
                                                ]
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "minimum life expectancy of 12 weeks",
                                        "criterion": "life expectancy",
                                        "requirement": {
                                            "requirement_type": "minimum",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 12,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "no deterioration over the past 2 weeks",
                                "criterion": "deterioration",
                                "requirement": {
                                    "requirement_type": "absence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Aspartate aminotransferase (AST) ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases",
                "criterions": [
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ≤ 2.5 × ULN if no demonstrable liver metastases",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "× ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ≤ 2.5 × ULN if no demonstrable liver metastases",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "no demonstrable liver metastases"
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... ≤ 5 × ULN in the presence of liver metastases",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "× ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... ≤ 5 × ULN in the presence of liver metastases",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "presence of liver metastases"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "condition": {
                        "exact_snippets": "Aspartate aminotransferase (AST) ≤ 2.5 × ULN if no demonstrable liver metastases",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "no demonstrable liver metastases"
                        }
                    },
                    "then_criteria": {
                        "exact_snippets": "Aspartate aminotransferase (AST) ≤ 2.5 × ULN if no demonstrable liver metastases",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "× ULN"
                                    }
                                ]
                            }
                        }
                    },
                    "else_criteria": {
                        "condition": {
                            "condition": {
                                "exact_snippets": "Aspartate aminotransferase (AST) ... ≤ 5 × ULN in the presence of liver metastases",
                                "criterion": "aspartate aminotransferase (AST)",
                                "requirement": {
                                    "requirement_type": "condition",
                                    "expected_value": "presence of liver metastases"
                                }
                            },
                            "then_criteria": {
                                "exact_snippets": "Aspartate aminotransferase (AST) ... ≤ 5 × ULN in the presence of liver metastases",
                                "criterion": "aspartate aminotransferase (AST)",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 5,
                                                "unit": "× ULN"
                                            }
                                        ]
                                    }
                                }
                            },
                            "else_criteria": null
                        },
                        "then_criteria": null,
                        "else_criteria": null
                    }
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "7. Creatinine ≤ 1.5 × ULN concurrent with creatinine clearance ≥ 50 mL/min (measured or calculated by the Cockcroft-Gault equation); confirmation of creatinine clearance is only required when creatinine is ≤ 1.5×ULN",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine ≤ 1.5 × ULN",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance ≥ 50 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "clearance rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "confirmation of creatinine clearance is only required when creatinine is ≤ 1.5×ULN",
                        "criterion": "confirmation of creatinine clearance",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "only required when creatinine is ≤ 1.5×ULN"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Creatinine ≤ 1.5 × ULN",
                            "criterion": "creatinine level",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 1.5,
                                    "unit": "× ULN"
                                }
                            }
                        },
                        {
                            "exact_snippets": "creatinine clearance ≥ 50 mL/min",
                            "criterion": "creatinine clearance",
                            "requirement": {
                                "requirement_type": "clearance rate",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 50,
                                    "unit": "mL/min"
                                }
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "confirmation of creatinine clearance is only required when creatinine is ≤ 1.5×ULN",
                    "criterion": "confirmation of creatinine clearance",
                    "requirement": {
                        "requirement_type": "condition",
                        "expected_value": "only required when creatinine is ≤ 1.5×ULN"
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "8. Serum albumin (ALB) ≥28 g/L",
                "criterions": [
                    {
                        "exact_snippets": "Serum albumin (ALB) ≥28 g/L",
                        "criterion": "serum albumin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "g/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serum albumin (ALB) ≥28 g/L",
                        "criterion": "serum albumin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "g/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Coagulation function: International standardized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN",
                "criterions": [
                    {
                        "exact_snippets": "Coagulation function: International standardized ratio (INR) ≤1.5",
                        "criterion": "International standardized ratio (INR)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Coagulation function: ... activated partial thromboplastin time (APTT) ≤1.5×ULN",
                        "criterion": "activated partial thromboplastin time (APTT)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "×ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Coagulation function: International standardized ratio (INR) ≤1.5",
                        "criterion": "International standardized ratio (INR)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Coagulation function: ... activated partial thromboplastin time (APTT) ≤1.5×ULN",
                        "criterion": "activated partial thromboplastin time (APTT)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "×ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Females of child-bearing potential should be using adequate contraceptive measures throughout the study, should not be breast feeding during the study and until 6 months after treatment, and must have a negative pregnancy test prior to start of dosing.",
                "criterions": [
                    {
                        "exact_snippets": "Females of child-bearing potential",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Females of child-bearing potential",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "reproductive status",
                            "expected_value": "child-bearing potential"
                        }
                    },
                    {
                        "exact_snippets": "using adequate contraceptive measures throughout the study",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "throughout the study"
                        }
                    },
                    {
                        "exact_snippets": "using adequate contraceptive measures throughout the study",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    },
                    {
                        "exact_snippets": "should not be breast feeding during the study and until 6 months after treatment",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "should not be breast feeding during the study and until 6 months after treatment",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the study and until 6 months after treatment"
                        }
                    },
                    {
                        "exact_snippets": "must have a negative pregnancy test prior to start of dosing",
                        "criterion": "pregnancy test result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "must have a negative pregnancy test prior to start of dosing",
                        "criterion": "pregnancy test result",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "prior to start of dosing"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Females of child-bearing potential",
                                "criterion": "gender and reproductive status",
                                "requirement": {
                                    "requirement_type": "gender",
                                    "expected_value": "female"
                                }
                            },
                            {
                                "exact_snippets": "Females of child-bearing potential",
                                "criterion": "gender and reproductive status",
                                "requirement": {
                                    "requirement_type": "reproductive status",
                                    "expected_value": "child-bearing potential"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "using adequate contraceptive measures throughout the study",
                                        "criterion": "contraceptive use",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": "throughout the study"
                                        }
                                    },
                                    {
                                        "exact_snippets": "using adequate contraceptive measures throughout the study",
                                        "criterion": "contraceptive use",
                                        "requirement": {
                                            "requirement_type": "adequacy",
                                            "expected_value": "adequate"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "should not be breast feeding during the study and until 6 months after treatment",
                                                "criterion": "breastfeeding status",
                                                "requirement": {
                                                    "requirement_type": "prohibition",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "should not be breast feeding during the study and until 6 months after treatment",
                                                "criterion": "breastfeeding status",
                                                "requirement": {
                                                    "requirement_type": "duration",
                                                    "expected_value": "during the study and until 6 months after treatment"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "must have a negative pregnancy test prior to start of dosing",
                                                "criterion": "pregnancy test result",
                                                "requirement": {
                                                    "requirement_type": "result",
                                                    "expected_value": "negative"
                                                }
                                            },
                                            {
                                                "exact_snippets": "must have a negative pregnancy test prior to start of dosing",
                                                "criterion": "pregnancy test result",
                                                "requirement": {
                                                    "requirement_type": "timing",
                                                    "expected_value": "prior to start of dosing"
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Male patients should be willing to use barrier contraception during the study and until 6 months after treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Male patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": "willing to use barrier contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "during the study and until 6 months after treatment",
                        "criterion": "contraception use duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the study and until 6 months after treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Male patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": "willing to use barrier contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "during the study and until 6 months after treatment",
                        "criterion": "contraception use duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the study and until 6 months after treatment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must sign and date written informed consent prior to admission to the study.",
                "criterions": [
                    {
                        "exact_snippets": "Patients must sign and date written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must sign and date written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "completion",
                            "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": {
                "and_criteria": [
                    {
                        "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",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate bone marrow reserve or organ function, as demonstrated by the following laboratory values (no corrective treatment allowed within one week before blood sampling):",
                "criterions": [
                    {
                        "exact_snippets": "Adequate bone marrow reserve",
                        "criterion": "bone marrow reserve",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate ... organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Adequate bone marrow reserve",
                        "criterion": "bone marrow reserve",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate ... organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients with unresectable or metastatic lesions, residual lesions after surgery, or those who have had only segmentectomies or wedge resection.",
                "criterions": [
                    {
                        "exact_snippets": "unresectable or metastatic lesions",
                        "criterion": "lesions",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unresectable or metastatic lesions",
                        "criterion": "lesions",
                        "requirement": {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "residual lesions after surgery",
                        "criterion": "lesions",
                        "requirement": {
                            "requirement_type": "residual",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "residual lesions after surgery",
                        "criterion": "lesions",
                        "requirement": {
                            "requirement_type": "post-surgery",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "only segmentectomies or wedge resection",
                        "criterion": "surgical history",
                        "requirement": {
                            "requirement_type": "surgery type",
                            "expected_value": [
                                "segmentectomy",
                                "wedge resection"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "unresectable or metastatic lesions",
                                        "criterion": "lesions",
                                        "requirement": {
                                            "requirement_type": "resectability",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "unresectable or metastatic lesions",
                                        "criterion": "lesions",
                                        "requirement": {
                                            "requirement_type": "metastasis",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "residual lesions after surgery",
                                        "criterion": "lesions",
                                        "requirement": {
                                            "requirement_type": "residual",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "residual lesions after surgery",
                                        "criterion": "lesions",
                                        "requirement": {
                                            "requirement_type": "post-surgery",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "only segmentectomies or wedge resection",
                        "criterion": "surgical history",
                        "requirement": {
                            "requirement_type": "surgery type",
                            "expected_value": [
                                "segmentectomy",
                                "wedge resection"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Giant mediastinal lymph node metastasis at a single station or mediastinal lymph node fusion into a cluster at multiple stations; lesions invade the heart, aorta, esophagus, or pulmonary veins; Carcinoma of superior lung sulci.",
                "criterions": [
                    {
                        "exact_snippets": "Giant mediastinal lymph node metastasis",
                        "criterion": "mediastinal lymph node metastasis",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": "giant"
                        }
                    },
                    {
                        "exact_snippets": "mediastinal lymph node fusion into a cluster",
                        "criterion": "mediastinal lymph node fusion",
                        "requirement": {
                            "requirement_type": "formation",
                            "expected_value": "cluster"
                        }
                    },
                    {
                        "exact_snippets": "lesions invade the heart",
                        "criterion": "lesion invasion",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "heart"
                        }
                    },
                    {
                        "exact_snippets": "lesions invade the ... aorta",
                        "criterion": "lesion invasion",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "aorta"
                        }
                    },
                    {
                        "exact_snippets": "lesions invade the ... esophagus",
                        "criterion": "lesion invasion",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "esophagus"
                        }
                    },
                    {
                        "exact_snippets": "lesions invade the ... pulmonary veins",
                        "criterion": "lesion invasion",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "pulmonary veins"
                        }
                    },
                    {
                        "exact_snippets": "Carcinoma of superior lung sulci",
                        "criterion": "carcinoma",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "superior lung sulci"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Giant mediastinal lymph node metastasis",
                                        "criterion": "mediastinal lymph node metastasis",
                                        "requirement": {
                                            "requirement_type": "size",
                                            "expected_value": "giant"
                                        }
                                    },
                                    {
                                        "exact_snippets": "mediastinal lymph node fusion into a cluster",
                                        "criterion": "mediastinal lymph node fusion",
                                        "requirement": {
                                            "requirement_type": "formation",
                                            "expected_value": "cluster"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "mediastinal lymph node fusion into a cluster",
                                        "criterion": "mediastinal lymph node fusion",
                                        "requirement": {
                                            "requirement_type": "formation",
                                            "expected_value": "cluster"
                                        }
                                    },
                                    {
                                        "exact_snippets": "lesions invade the heart",
                                        "criterion": "lesion invasion",
                                        "requirement": {
                                            "requirement_type": "location",
                                            "expected_value": "heart"
                                        }
                                    },
                                    {
                                        "exact_snippets": "lesions invade the ... aorta",
                                        "criterion": "lesion invasion",
                                        "requirement": {
                                            "requirement_type": "location",
                                            "expected_value": "aorta"
                                        }
                                    },
                                    {
                                        "exact_snippets": "lesions invade the ... esophagus",
                                        "criterion": "lesion invasion",
                                        "requirement": {
                                            "requirement_type": "location",
                                            "expected_value": "esophagus"
                                        }
                                    },
                                    {
                                        "exact_snippets": "lesions invade the ... pulmonary veins",
                                        "criterion": "lesion invasion",
                                        "requirement": {
                                            "requirement_type": "location",
                                            "expected_value": "pulmonary veins"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Carcinoma of superior lung sulci",
                        "criterion": "carcinoma",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "superior lung sulci"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Treatment with any of the following (except for standard platinum -based adjuvant chemotherapy), including any EGFR-TKI, systemic chemotherapy，immunotherapy, targeted therapy and anti-tumor traditional Chinese medicine therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Treatment with any of the following ... including any EGFR-TKI",
                        "criterion": "EGFR-TKI treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Treatment with any of the following ... systemic chemotherapy",
                        "criterion": "systemic chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Treatment with any of the following ... immunotherapy",
                        "criterion": "immunotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Treatment with any of the following ... targeted therapy",
                        "criterion": "targeted therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Treatment with any of the following ... anti-tumor traditional Chinese medicine therapy",
                        "criterion": "anti-tumor traditional Chinese medicine therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Treatment with any of the following ... including any EGFR-TKI",
                            "criterion": "EGFR-TKI treatment",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Treatment with any of the following ... systemic chemotherapy",
                            "criterion": "systemic chemotherapy",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Treatment with any of the following ... immunotherapy",
                            "criterion": "immunotherapy",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Treatment with any of the following ... targeted therapy",
                            "criterion": "targeted therapy",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Treatment with any of the following ... anti-tumor traditional Chinese medicine therapy",
                            "criterion": "anti-tumor traditional Chinese medicine therapy",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.",
                    "criterion": "major surgery",
                    "requirement": {
                        "requirement_type": "time since surgery",
                        "expected_value": {
                            "operator": "<",
                            "value": 4,
                            "unit": "weeks"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* The patient is currently using (or cannot discontinue at least 1 week before the first dose of study drug) a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                "criterions": [
                    {
                        "exact_snippets": "The patient is currently using ... a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                        "criterion": "use of a drug or herbal supplement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The patient is currently using ... a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                        "criterion": "use of a drug or herbal supplement",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "potent inhibitor or inducer of CYP3A4"
                        }
                    },
                    {
                        "exact_snippets": "cannot discontinue at least 1 week before the first dose of study drug ... a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                        "criterion": "discontinuation of a drug or herbal supplement",
                        "requirement": {
                            "requirement_type": "time before first dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    },
                    {
                        "exact_snippets": "cannot discontinue at least 1 week before the first dose of study drug ... a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                        "criterion": "discontinuation of a drug or herbal supplement",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "potent inhibitor or inducer of CYP3A4"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "The patient is currently using ... a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                                        "criterion": "use of a drug or herbal supplement",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "The patient is currently using ... a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                                        "criterion": "use of a drug or herbal supplement",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "potent inhibitor or inducer of CYP3A4"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "cannot discontinue at least 1 week before the first dose of study drug ... a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                                        "criterion": "discontinuation of a drug or herbal supplement",
                                        "requirement": {
                                            "requirement_type": "time before first dose",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 1,
                                                "unit": "week"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "cannot discontinue at least 1 week before the first dose of study drug ... a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                                        "criterion": "discontinuation of a drug or herbal supplement",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "potent inhibitor or inducer of CYP3A4"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Severe infections occurred within 4 weeks or active infections that received therapeutic intravenous or oral antibiotics within 2 weeks before the first dose.",
                "criterions": [
                    {
                        "exact_snippets": "Severe infections occurred within 4 weeks",
                        "criterion": "severe infections",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "active infections that received therapeutic intravenous or oral antibiotics within 2 weeks",
                        "criterion": "active infections",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "therapeutic intravenous antibiotics",
                                "therapeutic oral antibiotics"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "active infections that received therapeutic intravenous or oral antibiotics within 2 weeks",
                        "criterion": "active infections",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Severe infections occurred within 4 weeks",
                                "criterion": "severe infections",
                                "requirement": {
                                    "requirement_type": "timeframe",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "active infections that received therapeutic intravenous or oral antibiotics within 2 weeks",
                                "criterion": "active infections",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": [
                                        "therapeutic intravenous antibiotics",
                                        "therapeutic oral antibiotics"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "active infections that received therapeutic intravenous or oral antibiotics within 2 weeks",
                                "criterion": "active infections",
                                "requirement": {
                                    "requirement_type": "timeframe",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any evidence of active infection (including hepatitis B, hepatitis C, and human immunodeficiency virus).",
                "criterions": [
                    {
                        "exact_snippets": "evidence of active infection",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hepatitis B",
                        "criterion": "hepatitis B",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hepatitis C",
                        "criterion": "hepatitis C",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "human immunodeficiency virus",
                        "criterion": "human immunodeficiency virus",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "evidence of active infection",
                                "criterion": "active infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "hepatitis B",
                                        "criterion": "hepatitis B",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "hepatitis C",
                                        "criterion": "hepatitis C",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "human immunodeficiency virus",
                                        "criterion": "human immunodeficiency virus",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients received continuous steroid therapy for more than 30 days within 30 days before the first dose; require long-term (≥30 days) steroid therapy; with acquired or congenital immunodeficiency diseases or have a history of organ transplantation.",
                "criterions": [
                    {
                        "exact_snippets": "Patients received continuous steroid therapy for more than 30 days within 30 days before the first dose",
                        "criterion": "continuous steroid therapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients received continuous steroid therapy for more than 30 days within 30 days before the first dose",
                        "criterion": "continuous steroid therapy",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "within 30 days before the first dose"
                        }
                    },
                    {
                        "exact_snippets": "require long-term (≥30 days) steroid therapy",
                        "criterion": "long-term steroid therapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "with acquired or congenital immunodeficiency diseases",
                        "criterion": "immunodeficiency diseases",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "acquired",
                                "congenital"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "have a history of organ transplantation",
                        "criterion": "history of organ transplantation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients received continuous steroid therapy for more than 30 days within 30 days before the first dose",
                                "criterion": "continuous steroid therapy",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Patients received continuous steroid therapy for more than 30 days within 30 days before the first dose",
                                "criterion": "continuous steroid therapy",
                                "requirement": {
                                    "requirement_type": "timeframe",
                                    "expected_value": "within 30 days before the first dose"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "require long-term (≥30 days) steroid therapy",
                        "criterion": "long-term steroid therapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "with acquired or congenital immunodeficiency diseases",
                        "criterion": "immunodeficiency diseases",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "acquired",
                                "congenital"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "have a history of organ transplantation",
                        "criterion": "history of organ transplantation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Severe or uncontrolled systemic diseases, including hypertension or diabetes.",
                "criterions": [
                    {
                        "exact_snippets": "Severe or uncontrolled systemic diseases, including hypertension",
                        "criterion": "systemic diseases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Severe or uncontrolled systemic diseases, including hypertension",
                        "criterion": "systemic diseases",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Severe or uncontrolled systemic diseases, including ... diabetes",
                        "criterion": "diabetes",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Severe or uncontrolled systemic diseases, including hypertension",
                                "criterion": "systemic diseases",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "Severe or uncontrolled systemic diseases, including hypertension",
                                "criterion": "systemic diseases",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Severe or uncontrolled systemic diseases, including ... diabetes",
                        "criterion": "diabetes",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any of the following cardiac criteria:",
                "criterions": [
                    {
                        "exact_snippets": "Any of the following cardiac criteria",
                        "criterion": "cardiac criteria",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Any of the following cardiac criteria",
                        "criterion": "cardiac criteria",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Mean resting corrected QT interval (QTcF) > 470 msec obtained from 3 electrocardiograms (ECGs), using the Screening clinic's ECG machine and Fridericia's formula for QT interval correction.",
                "criterions": [
                    {
                        "exact_snippets": "Mean resting corrected QT interval (QTcF) > 470 msec",
                        "criterion": "mean resting corrected QT interval (QTcF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Mean resting corrected QT interval (QTcF) > 470 msec",
                        "criterion": "mean resting corrected QT interval (QTcF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250 msec).",
                "criterions": [
                    {
                        "exact_snippets": "clinically important abnormalities in rhythm",
                        "criterion": "ECG rhythm",
                        "requirement": {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "clinically important abnormalities in ... conduction",
                        "criterion": "ECG conduction",
                        "requirement": {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "clinically important abnormalities in ... morphology of the resting ECG",
                        "criterion": "ECG morphology",
                        "requirement": {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "complete left bundle branch block",
                        "criterion": "left bundle branch block",
                        "requirement": {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "third-degree heart block",
                        "criterion": "heart block",
                        "requirement": {
                            "requirement_type": "degree",
                            "expected_value": "third-degree"
                        }
                    },
                    {
                        "exact_snippets": "second-degree heart block",
                        "criterion": "heart block",
                        "requirement": {
                            "requirement_type": "degree",
                            "expected_value": "second-degree"
                        }
                    },
                    {
                        "exact_snippets": "PR interval >250 msec",
                        "criterion": "PR interval",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 250,
                                "unit": "msec"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "clinically important abnormalities in rhythm",
                                "criterion": "ECG rhythm",
                                "requirement": {
                                    "requirement_type": "abnormality",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "clinically important abnormalities in ... conduction",
                                "criterion": "ECG conduction",
                                "requirement": {
                                    "requirement_type": "abnormality",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "clinically important abnormalities in ... morphology of the resting ECG",
                                "criterion": "ECG morphology",
                                "requirement": {
                                    "requirement_type": "abnormality",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "complete left bundle branch block",
                        "criterion": "left bundle branch block",
                        "requirement": {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "third-degree heart block",
                        "criterion": "heart block",
                        "requirement": {
                            "requirement_type": "degree",
                            "expected_value": "third-degree"
                        }
                    },
                    {
                        "exact_snippets": "second-degree heart block",
                        "criterion": "heart block",
                        "requirement": {
                            "requirement_type": "degree",
                            "expected_value": "second-degree"
                        }
                    },
                    {
                        "exact_snippets": "PR interval >250 msec",
                        "criterion": "PR interval",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 250,
                                "unit": "msec"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.",
                "criterions": [
                    {
                        "exact_snippets": "factors that increase the risk of QTc prolongation or risk of arrhythmic events",
                        "criterion": "risk factors for QTc prolongation or arrhythmic events",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "heart failure",
                        "criterion": "heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hypokalemia",
                        "criterion": "hypokalemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "congenital long QT syndrome",
                        "criterion": "congenital long QT syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "family history of long QT syndrome",
                        "criterion": "family history of long QT syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unexplained sudden death under 40 years of age in first degree relatives",
                        "criterion": "unexplained sudden death under 40 years of age in first degree relatives",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "any concomitant medication known to prolong the QT interval",
                        "criterion": "concomitant medication known to prolong the QT interval",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "factors that increase the risk of QTc prolongation or risk of arrhythmic events",
                        "criterion": "risk factors for QTc prolongation or arrhythmic events",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "heart failure",
                        "criterion": "heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hypokalemia",
                        "criterion": "hypokalemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "congenital long QT syndrome",
                        "criterion": "congenital long QT syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "family history of long QT syndrome",
                        "criterion": "family history of long QT syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unexplained sudden death under 40 years of age in first degree relatives",
                        "criterion": "unexplained sudden death under 40 years of age in first degree relatives",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "any concomitant medication known to prolong the QT interval",
                        "criterion": "concomitant medication known to prolong the QT interval",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Left ventricular ejection fraction (LVEF) <50%.",
                "criterions": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction (LVEF) <50%",
                        "criterion": "left ventricular ejection fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction (LVEF) <50%",
                        "criterion": "left ventricular ejection fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.",
                "criterions": [
                    {
                        "exact_snippets": "History of interstitial lung disease (ILD)",
                        "criterion": "interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "drug-induced ILD",
                        "criterion": "drug-induced interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "radiation pneumonitis which required steroid treatment",
                        "criterion": "radiation pneumonitis",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "steroid"
                        }
                    },
                    {
                        "exact_snippets": "any evidence of clinically active ILD",
                        "criterion": "clinically active interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of interstitial lung disease (ILD)",
                        "criterion": "interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "drug-induced ILD",
                        "criterion": "drug-induced interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "radiation pneumonitis which required steroid treatment",
                        "criterion": "radiation pneumonitis",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "steroid"
                        }
                    },
                    {
                        "exact_snippets": "any evidence of clinically active ILD",
                        "criterion": "clinically active interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of any other malignant tumor within five years (except clinically cured cervical carcinoma in situ, basal cells or squamous epithelial skin cancer).",
                "criterions": [
                    {
                        "exact_snippets": "History of any other malignant tumor within five years",
                        "criterion": "history of malignant tumor",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "except clinically cured cervical carcinoma in situ",
                        "criterion": "clinically cured cervical carcinoma in situ",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "except ... basal cells or squamous epithelial skin cancer",
                        "criterion": "basal cells or squamous epithelial skin cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "except clinically cured cervical carcinoma in situ",
                                    "criterion": "clinically cured cervical carcinoma in situ",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "exact_snippets": "except ... basal cells or squamous epithelial skin cancer",
                                    "criterion": "basal cells or squamous epithelial skin cancer",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": "History of any other malignant tumor within five years",
                        "criterion": "history of malignant tumor",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any seriously abnormal gastrointestinal function would affect uptake, transport and absorption of the drug, such as inability to swallow the study medication, refractory nausea and vomiting, previous significant bowel resection, Recurrent diarrhea, atrophic gastritis (age < 60 years), unhealed serious gastric diseases, Crohn's disease or ulcerative colitis.",
                "criterions": [
                    {
                        "exact_snippets": "seriously abnormal gastrointestinal function",
                        "criterion": "gastrointestinal function",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "seriously abnormal"
                        }
                    },
                    {
                        "exact_snippets": "inability to swallow the study medication",
                        "criterion": "ability to swallow study medication",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "refractory nausea and vomiting",
                        "criterion": "nausea and vomiting",
                        "requirement": {
                            "requirement_type": "refractory",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "previous significant bowel resection",
                        "criterion": "bowel resection",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Recurrent diarrhea",
                        "criterion": "diarrhea",
                        "requirement": {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "atrophic gastritis (age < 60 years)",
                        "criterion": "atrophic gastritis",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "unhealed serious gastric diseases",
                        "criterion": "serious gastric diseases",
                        "requirement": {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        }
                    },
                    {
                        "exact_snippets": "Crohn's disease",
                        "criterion": "Crohn's disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ulcerative colitis",
                        "criterion": "ulcerative colitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "seriously abnormal gastrointestinal function",
                                "criterion": "gastrointestinal function",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "seriously abnormal"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "inability to swallow the study medication",
                                        "criterion": "ability to swallow study medication",
                                        "requirement": {
                                            "requirement_type": "ability",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "refractory nausea and vomiting",
                                        "criterion": "nausea and vomiting",
                                        "requirement": {
                                            "requirement_type": "refractory",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "previous significant bowel resection",
                                        "criterion": "bowel resection",
                                        "requirement": {
                                            "requirement_type": "history",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Recurrent diarrhea",
                                        "criterion": "diarrhea",
                                        "requirement": {
                                            "requirement_type": "recurrence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "atrophic gastritis (age < 60 years)",
                                        "criterion": "atrophic gastritis",
                                        "requirement": {
                                            "requirement_type": "age",
                                            "expected_value": {
                                                "operator": "<",
                                                "value": 60,
                                                "unit": "years"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "unhealed serious gastric diseases",
                                        "criterion": "serious gastric diseases",
                                        "requirement": {
                                            "requirement_type": "healing status",
                                            "expected_value": "unhealed"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Crohn's disease",
                                        "criterion": "Crohn's disease",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "ulcerative colitis",
                                        "criterion": "ulcerative colitis",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of hypersensitivity to any active or inactive ingredient of SH-1028 or drug with a similar chemical structure or class to SH-1028.",
                "criterions": [
                    {
                        "exact_snippets": "History of hypersensitivity to any active or inactive ingredient of SH-1028",
                        "criterion": "hypersensitivity to SH-1028 ingredients",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity to ... drug with a similar chemical structure or class to SH-1028",
                        "criterion": "hypersensitivity to similar drugs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of hypersensitivity to any active or inactive ingredient of SH-1028",
                        "criterion": "hypersensitivity to SH-1028 ingredients",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity to ... drug with a similar chemical structure or class to SH-1028",
                        "criterion": "hypersensitivity to similar drugs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any severe and uncontrolled ocular disease that may, in the Investigator's opinion, present a specific risk to the patient's safety.",
                "criterions": [
                    {
                        "exact_snippets": "severe and uncontrolled ocular disease",
                        "criterion": "ocular disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "severe and uncontrolled ocular disease",
                        "criterion": "ocular disease",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "present a specific risk to the patient's safety",
                        "criterion": "risk to patient's safety",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "severe and uncontrolled ocular disease",
                                "criterion": "ocular disease",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "severe and uncontrolled ocular disease",
                                "criterion": "ocular disease",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "present a specific risk to the patient's safety",
                        "criterion": "risk to patient's safety",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participating in another clinical trial within 4 weeks before the first dose (excluding retrospective observational studies without intervention); within 5 half-lives of other study drugs.",
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                    {
                        "exact_snippets": "Participating in another clinical trial within 4 weeks before the first dose",
                        "criterion": "participation in another clinical trial",
                        "requirement": {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "within 5 half-lives of other study drugs",
                        "criterion": "time since last dose of other study drugs",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participating in another clinical trial within 4 weeks before the first dose",
                                "criterion": "participation in another clinical trial",
                                "requirement": {
                                    "requirement_type": "time since last participation",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "Participating in another clinical trial within 4 weeks before the first dose",
                                    "criterion": "participation in another clinical trial",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": "retrospective observational study without intervention"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "within 5 half-lives of other study drugs",
                        "criterion": "time since last dose of other study drugs",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hepatic encephalopathy, hepatorenal syndrome, or ≥Child-Pugh grade B cirrhosis.",
                "criterions": [
                    {
                        "exact_snippets": "Hepatic encephalopathy",
                        "criterion": "hepatic encephalopathy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hepatorenal syndrome",
                        "criterion": "hepatorenal syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "≥Child-Pugh grade B cirrhosis",
                        "criterion": "Child-Pugh grade cirrhosis",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "Child-Pugh score"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Hepatic encephalopathy",
                        "criterion": "hepatic encephalopathy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hepatorenal syndrome",
                        "criterion": "hepatorenal syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "≥Child-Pugh grade B cirrhosis",
                        "criterion": "Child-Pugh grade cirrhosis",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "Child-Pugh score"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Lactating Women.",
                "criterions": [
                    {
                        "exact_snippets": "Lactating Women",
                        "criterion": "lactation status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "lactating"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Lactating Women",
                        "criterion": "lactation status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "lactating"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.",
                "criterions": [
                    {
                        "exact_snippets": "Any disease or condition ... would compromise the safety of the patient",
                        "criterion": "disease or condition",
                        "requirement": {
                            "requirement_type": "impact on safety",
                            "expected_value": "compromise"
                        }
                    },
                    {
                        "exact_snippets": "Any disease or condition ... interfere with study assessments",
                        "criterion": "disease or condition",
                        "requirement": {
                            "requirement_type": "impact on study assessments",
                            "expected_value": "interfere"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any disease or condition ... would compromise the safety of the patient",
                                "criterion": "disease or condition",
                                "requirement": {
                                    "requirement_type": "impact on safety",
                                    "expected_value": "compromise"
                                }
                            },
                            {
                                "exact_snippets": "Any disease or condition ... interfere with study assessments",
                                "criterion": "disease or condition",
                                "requirement": {
                                    "requirement_type": "impact on study assessments",
                                    "expected_value": "interfere"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Male or female, aged at least 18 years, younger than 75 years.",
                "criterions": [
                    {
                        "exact_snippets": "Male or female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "aged at least 18 years, younger than 75 years",
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                            "requirement_type": "range",
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                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Male or female",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "N/A",
                                    "expected_value": [
                                        "male"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "Male or female",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "N/A",
                                    "expected_value": [
                                        "female"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "aged at least 18 years, younger than 75 years",
                        "criterion": "age",
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                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Absolute neutrophil count (ANC）≥1.5×10^9 /L",
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                    {
                        "exact_snippets": "Absolute neutrophil count (ANC）≥1.5×10^9 /L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9 /L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
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                    "requirement_type": "failed",
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            }
        },
        {
            "identified_line": {
                "line": "2. Platelet count ≥100×10^9 /L",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count ≥100×10^9 /L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9 /L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
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                    "requirement_type": "failed",
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            }
        },
        {
            "identified_line": {
                "line": "3. Hemoglobin ≥90 g/L",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin ≥90 g/L",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
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                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases",
                "criterions": [
                    {
                        "exact_snippets": "Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases",
                        "criterion": "Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "× ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases",
                        "criterion": "Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "no demonstrable liver metastases"
                        }
                    },
                    {
                        "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 5 × ULN in the presence of liver metastases",
                        "criterion": "Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "× ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 5 × ULN in the presence of liver metastases",
                        "criterion": "Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "presence of liver metastases"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Total bilirubin (TBL) ≤ 1.5 × ULN if no liver metastases or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin (TBL) ≤ 1.5 × ULN if no liver metastases",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "× ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Total bilirubin (TBL) ... ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "× ULN"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
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                        "exact_snippets": "no liver metastases",
                        "criterion": "liver metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    "then_criteria": {
                        "exact_snippets": "Total bilirubin (TBL) ≤ 1.5 × ULN if no liver metastases",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "× ULN"
                                    }
                                ]
                            }
                        }
                    },
                    "else_criteria": {
                        "condition": {
                            "condition": {
                                "exact_snippets": "documented Gilbert's Syndrome (unconjugated hyperbilirubinemia)",
                                "criterion": "Gilbert's Syndrome",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            "then_criteria": {
                                "exact_snippets": "Total bilirubin (TBL) ... ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia)",
                                "criterion": "total bilirubin",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 3,
                                                "unit": "× ULN"
                                            }
                                        ]
                                    }
                                }
                            },
                            "else_criteria": {
                                "exact_snippets": "Total bilirubin (TBL) ... ≤ 3 × ULN ... liver metastases",
                                "criterion": "total bilirubin",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 3,
                                                "unit": "× ULN"
                                            }
                                        ]
                                    }
                                }
                            }
                        },
                        "then_criteria": null,
                        "else_criteria": null
                    }
                },
                "then_criteria": null,
                "else_criteria": null
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Receiving or requiring drugs known to prolong the QT interval or possibly cause tip torsion ventricular tachycardia during the study.",
                "criterions": [
                    {
                        "exact_snippets": "Receiving or requiring drugs known to prolong the QT interval",
                        "criterion": "drugs known to prolong the QT interval",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Receiving or requiring drugs ... possibly cause tip torsion ventricular tachycardia",
                        "criterion": "drugs possibly causing tip torsion ventricular tachycardia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Receiving or requiring drugs known to prolong the QT interval",
                                "criterion": "drugs known to prolong the QT interval",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Receiving or requiring drugs ... possibly cause tip torsion ventricular tachycardia",
                                "criterion": "drugs possibly causing tip torsion ventricular tachycardia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}