{
    "info": {
        "nct_id": "NCT02580994",
        "official_title": "REACTION: A Phase II Study of Etoposide and Cis/Carboplatin With or Without Pembrolizumab in Untreated Extensive Small Cell Lung Cancer",
        "inclusion_criteria": "* Histologically or cytologically confirmed SCLC\n* Extended disease according to the criteria of the Veteran's Administration - Lung Cancer Group (VALG): disease extended beyond a hemithorax and the supraclavicular node area. Pleural involvement will be considered as extended disease\n* Assessment of adequate tissue availability for Program Cell Death-Ligand 1 (PD-L1) immunohistochemistry testing\n* Before patient registration, written informed consent must be given according to International Conference of Harmonization-Good Clinical Practice (ICH-GCP), and national/local regulations\n* Tumor assessment performed within 10 days before randomization. Patient may or may not have measurable disease\n* Previous palliative brain radiotherapy is allowed if terminated at least 3 weeks before randomization\n* Partial or complete response according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 after 2 cycles of any platinum-based induction chemotherapy regimen\n* Adequate hematopoietic, hepatic and renal function within 10 days before randomization defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1.5 x 10E9/L, Hemoglobin (Hb) ≥ 9 g/dL and platelet count ≥ 100 x 10E9/L\n  * Serum creatinine clearance ≥ 60 mL/min as calculated with Cockcroft-Gault formula\n  * Bilirubin ≤ 1.5 x Upper Limit Normal (ULN), Alanine Aminotransferase (ALT) (SGTP) and Aspartate Transaminase (AST) (SGOT) ≤ 3 x ULN\n  * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n  * Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as a PTT is within therapeutic range of intended use of anticoagulants N.B. Lactate Dehydrogenase (LDH) level assessment is mandatory for randomization\n* Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 72 hours before randomization\n* Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by investigator, during the study treatment period and for at least 120 days after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n* Female subjects who are breast feeding should discontinue nursing before randomization and until 120 days after the last study treatment\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior systemic therapy for SCLC; previous treatment with platinum and etoposide concomitant with radiotherapy (RT) for limited disease is allowed if terminated at least 1 year before patient randomization\n* known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (i.e. without evidence of progression by imaging and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not received steroids for at least 7 days before randomization\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 3-4 (at registration) (patients who are judged by the investigator to be PS 2 due to primary disease are the only PS 2 patients who are eligible)\n* ECOG PS 2-4 (at randomization)\n* Less than 3 month life expectancy\n* History of interstitial lung disease (ILD) or a history of (non-infectious) pneumonitis that required oral or IV steroids (other than Chronic Obstructive Pulmonary Disease [COPD] exacerbation) or current pneumonitis or current evidence of ILD\n* Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs), any replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed\n* Previous allogeneic tissue/solid organ transplant\n* Active infection requiring therapy\n* Known history of Human Immunodeficiency Virus (HIV) (known HIV 1/2 antibodies positive). No known active Hepatitis B or C. Active Hepatitis B is defined as a known positive HBsAg results. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative Hepatitis C Virus (HCV) RNA results greater than the lower limits of detection of the assay\n* Ongoing grade ≥ 2 peripheral neuropathy\n* Prior treatment with platinum, anti-PD-1, anti-PD-L1/2, anti interleukin-7 receptor-alpha (anti-CD127), Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) modulators\n* Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the 3 days before randomization:\n* Corticosteroid use on study for management of pembrolizumab Events of Clinical Interest (ECIs), as pre-medication for the administration of chemotherapies, and/or a pre-medication for contrast allergies/reactions is allowed\n* Daily prednisone at doses of 5-7.5 mg is allowed as an example of replacement therapy. Equivalent hydrocortisone doses are also permitted if administered as a replacement therapy\n* Prior use of live vaccines within 30 days before randomization. Examples of live vaccines include, but are not limited to, the following : measles, mumps, rubella, chicken pox, shingles, yellow fever, influenza A virus subtype (H1N1) flu, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine\n* Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\n* Concurrent treatment with any investigational agent within 4 weeks before randomization",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Histologically or cytologically confirmed SCLC",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed SCLC",
                        "criterion": "SCLC",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed SCLC",
                        "criterion": "SCLC",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Assessment of adequate tissue availability for Program Cell Death-Ligand 1 (PD-L1) immunohistochemistry testing",
                "criterions": [
                    {
                        "exact_snippets": "adequate tissue availability for Program Cell Death-Ligand 1 (PD-L1) immunohistochemistry testing",
                        "criterion": "tissue availability for PD-L1 testing",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "adequate tissue availability for Program Cell Death-Ligand 1 (PD-L1) immunohistochemistry testing",
                        "criterion": "tissue availability for PD-L1 testing",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Before patient registration, written informed consent must be given according to International Conference of Harmonization-Good Clinical Practice (ICH-GCP), and national/local regulations",
                "criterions": [
                    {
                        "exact_snippets": "written informed consent must be given",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "according to International Conference of Harmonization-Good Clinical Practice (ICH-GCP), and national/local regulations",
                        "criterion": "compliance with ICH-GCP and national/local regulations",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "written informed consent must be given",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "according to International Conference of Harmonization-Good Clinical Practice (ICH-GCP), and national/local regulations",
                        "criterion": "compliance with ICH-GCP and national/local regulations",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Tumor assessment performed within 10 days before randomization. Patient may or may not have measurable disease",
                "criterions": [
                    {
                        "exact_snippets": "Tumor assessment performed within 10 days before randomization.",
                        "criterion": "tumor assessment",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patient may or may not have measurable disease",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "may",
                                "may not"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Tumor assessment performed within 10 days before randomization.",
                        "criterion": "tumor assessment",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patient may or may not have measurable disease",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "may",
                                "may not"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Previous palliative brain radiotherapy is allowed if terminated at least 3 weeks before randomization",
                "criterions": [
                    {
                        "exact_snippets": "Previous palliative brain radiotherapy is allowed if terminated at least 3 weeks before randomization",
                        "criterion": "palliative brain radiotherapy",
                        "requirement": {
                            "requirement_type": "time since termination",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Previous palliative brain radiotherapy is allowed if terminated at least 3 weeks before randomization",
                    "criterion": "palliative brain radiotherapy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Previous palliative brain radiotherapy is allowed if terminated at least 3 weeks before randomization",
                    "criterion": "palliative brain radiotherapy",
                    "requirement": {
                        "requirement_type": "time since termination",
                        "expected_value": {
                            "operator": ">=",
                            "value": 3,
                            "unit": "weeks"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Partial or complete response according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 after 2 cycles of any platinum-based induction chemotherapy regimen",
                "criterions": [
                    {
                        "exact_snippets": "Partial or complete response according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1",
                        "criterion": "tumor response",
                        "requirement": {
                            "requirement_type": "response type",
                            "expected_value": [
                                "partial",
                                "complete"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Partial or complete response according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1",
                        "criterion": "tumor response",
                        "requirement": {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    },
                    {
                        "exact_snippets": "after 2 cycles of any platinum-based induction chemotherapy regimen",
                        "criterion": "platinum-based induction chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "cycles",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "cycles"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Partial or complete response according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1",
                                "criterion": "tumor response",
                                "requirement": {
                                    "requirement_type": "response type",
                                    "expected_value": [
                                        "partial",
                                        "complete"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "Partial or complete response according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1",
                                "criterion": "tumor response",
                                "requirement": {
                                    "requirement_type": "evaluation criteria",
                                    "expected_value": "RECIST 1.1"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "after 2 cycles of any platinum-based induction chemotherapy regimen",
                        "criterion": "platinum-based induction chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "cycles",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "cycles"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate hematopoietic, hepatic and renal function within 10 days before randomization defined as follows:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate hematopoietic ... function",
                        "criterion": "hematopoietic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... hepatic ... function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate hematopoietic ... function",
                        "criterion": "hematopoietic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... hepatic ... function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count (ANC) ≥ 1.5 x 10E9/L, Hemoglobin (Hb) ≥ 9 g/dL and platelet count ≥ 100 x 10E9/L",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 x 10E9/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10E9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hemoglobin (Hb) ≥ 9 g/dL",
                        "criterion": "hemoglobin (Hb)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelet count ≥ 100 x 10E9/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10E9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 x 10E9/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10E9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hemoglobin (Hb) ≥ 9 g/dL",
                        "criterion": "hemoglobin (Hb)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelet count ≥ 100 x 10E9/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10E9/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serum creatinine clearance ≥ 60 mL/min as calculated with Cockcroft-Gault formula",
                "criterions": [
                    {
                        "exact_snippets": "Serum creatinine clearance ≥ 60 mL/min",
                        "criterion": "serum creatinine clearance",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serum creatinine clearance ≥ 60 mL/min",
                        "criterion": "serum creatinine clearance",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Bilirubin ≤ 1.5 x Upper Limit Normal (ULN), Alanine Aminotransferase (ALT) (SGTP) and Aspartate Transaminase (AST) (SGOT) ≤ 3 x ULN",
                "criterions": [
                    {
                        "exact_snippets": "Bilirubin ≤ 1.5 x Upper Limit Normal (ULN)",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alanine Aminotransferase (ALT) (SGTP) ... ≤ 3 x ULN",
                        "criterion": "alanine aminotransferase (ALT) level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate Transaminase (AST) (SGOT) ≤ 3 x ULN",
                        "criterion": "aspartate transaminase (AST) level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Bilirubin ≤ 1.5 x Upper Limit Normal (ULN)",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alanine Aminotransferase (ALT) (SGTP) ... ≤ 3 x ULN",
                        "criterion": "alanine aminotransferase (ALT) level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate Transaminase (AST) (SGOT) ≤ 3 x ULN",
                        "criterion": "aspartate transaminase (AST) level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 72 hours before randomization",
                "criterions": [
                    {
                        "exact_snippets": "Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 72 hours before randomization",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 72 hours before randomization",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 72 hours before randomization"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 72 hours before randomization",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 72 hours before randomization",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 72 hours before randomization"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by investigator, during the study treatment period and for at least 120 days after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.",
                "criterions": [
                    {
                        "exact_snippets": "Patients of childbearing / reproductive potential",
                        "criterion": "childbearing/reproductive potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "should use adequate birth control measures",
                        "criterion": "birth control measures",
                        "requirement": {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "during the study treatment period and for at least 120 days after the last study treatment",
                        "criterion": "duration of birth control usage",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the study treatment period and for at least 120 days after the last study treatment"
                        }
                    },
                    {
                        "exact_snippets": "A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year)",
                        "criterion": "effectiveness of birth control method",
                        "requirement": {
                            "requirement_type": "failure rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "% per year"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Patients of childbearing / reproductive potential",
                    "criterion": "childbearing/reproductive potential",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "should use adequate birth control measures",
                            "criterion": "birth control measures",
                            "requirement": {
                                "requirement_type": "usage",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "during the study treatment period and for at least 120 days after the last study treatment",
                            "criterion": "duration of birth control usage",
                            "requirement": {
                                "requirement_type": "duration",
                                "expected_value": "during the study treatment period and for at least 120 days after the last study treatment"
                            }
                        },
                        {
                            "exact_snippets": "A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year)",
                            "criterion": "effectiveness of birth control method",
                            "requirement": {
                                "requirement_type": "failure rate",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 1,
                                    "unit": "% per year"
                                }
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Female subjects who are breast feeding should discontinue nursing before randomization and until 120 days after the last study treatment",
                "criterions": [
                    {
                        "exact_snippets": "Female subjects who are breast feeding",
                        "criterion": "breast feeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "until 120 days after the last study treatment",
                        "criterion": "breast feeding",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 120,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "condition": {
                            "exact_snippets": "Female subjects who are breast feeding",
                            "criterion": "breast feeding",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        "then_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Female subjects who are breast feeding",
                                    "criterion": "breast feeding",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "exact_snippets": "until 120 days after the last study treatment",
                                    "criterion": "breast feeding",
                                    "requirement": {
                                        "requirement_type": "duration",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 120,
                                            "unit": "days"
                                        }
                                    }
                                }
                            ]
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "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"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Prior systemic therapy for SCLC; previous treatment with platinum and etoposide concomitant with radiotherapy (RT) for limited disease is allowed if terminated at least 1 year before patient randomization",
                "criterions": [
                    {
                        "exact_snippets": "Prior systemic therapy for SCLC",
                        "criterion": "prior systemic therapy for SCLC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "previous treatment with platinum and etoposide concomitant with radiotherapy (RT) for limited disease is allowed if terminated at least 1 year before patient randomization",
                        "criterion": "previous treatment with platinum and etoposide concomitant with radiotherapy (RT) for limited disease",
                        "requirement": {
                            "requirement_type": "termination time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Prior systemic therapy for SCLC",
                    "criterion": "prior systemic therapy for SCLC",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "not_criteria": {
                        "condition": {
                            "exact_snippets": "previous treatment with platinum and etoposide concomitant with radiotherapy (RT) for limited disease is allowed if terminated at least 1 year before patient randomization",
                            "criterion": "previous treatment with platinum and etoposide concomitant with radiotherapy (RT) for limited disease",
                            "requirement": {
                                "requirement_type": "termination time",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 1,
                                    "unit": "year"
                                }
                            }
                        },
                        "then_criteria": null,
                        "else_criteria": null
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (i.e. without evidence of progression by imaging and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not received steroids for at least 7 days before randomization",
                "criterions": [
                    {
                        "exact_snippets": "known active central nervous system (CNS) metastases",
                        "criterion": "active CNS metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "carcinomatous meningitis",
                        "criterion": "carcinomatous meningitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "previously treated brain metastases ... stable (i.e. without evidence of progression by imaging",
                        "criterion": "stability of previously treated brain metastases",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "previously treated brain metastases ... any neurologic symptoms have returned to baseline",
                        "criterion": "neurologic symptoms",
                        "requirement": {
                            "requirement_type": "baseline",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "no evidence of new or enlarging brain metastases",
                        "criterion": "new or enlarging brain metastases",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "have not received steroids for at least 7 days before randomization",
                        "criterion": "steroid use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "known active central nervous system (CNS) metastases",
                                        "criterion": "active CNS metastases",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "carcinomatous meningitis",
                                        "criterion": "carcinomatous meningitis",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "not_criteria": {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "previously treated brain metastases ... stable (i.e. without evidence of progression by imaging",
                                            "criterion": "stability of previously treated brain metastases",
                                            "requirement": {
                                                "requirement_type": "progression",
                                                "expected_value": false
                                            }
                                        },
                                        {
                                            "exact_snippets": "previously treated brain metastases ... any neurologic symptoms have returned to baseline",
                                            "criterion": "neurologic symptoms",
                                            "requirement": {
                                                "requirement_type": "baseline",
                                                "expected_value": true
                                            }
                                        },
                                        {
                                            "exact_snippets": "no evidence of new or enlarging brain metastases",
                                            "criterion": "new or enlarging brain metastases",
                                            "requirement": {
                                                "requirement_type": "evidence",
                                                "expected_value": false
                                            }
                                        },
                                        {
                                            "exact_snippets": "have not received steroids for at least 7 days before randomization",
                                            "criterion": "steroid use",
                                            "requirement": {
                                                "requirement_type": "duration",
                                                "expected_value": {
                                                    "operator": ">=",
                                                    "value": 7,
                                                    "unit": "days"
                                                }
                                            }
                                        }
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 3-4 (at registration) (patients who are judged by the investigator to be PS 2 due to primary disease are the only PS 2 patients who are eligible)",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 3-4 (at registration)",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "patients who are judged by the investigator to be PS 2 due to primary disease are the only PS 2 patients who are eligible",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "specific condition",
                            "expected_value": "PS 2 due to primary disease"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 3-4 (at registration)",
                                    "criterion": "ECOG Performance Status",
                                    "requirement": {
                                        "requirement_type": "range",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": ">=",
                                                    "value": 3,
                                                    "unit": "N/A"
                                                },
                                                {
                                                    "operator": "<=",
                                                    "value": 4,
                                                    "unit": "N/A"
                                                }
                                            ]
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "patients who are judged by the investigator to be PS 2 due to primary disease are the only PS 2 patients who are eligible",
                                        "criterion": "ECOG Performance Status",
                                        "requirement": {
                                            "requirement_type": "specific condition",
                                            "expected_value": "PS 2 due to primary disease"
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG PS 2-4 (at randomization)",
                "criterions": [
                    {
                        "exact_snippets": "ECOG PS 2-4",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG PS 2-4",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Less than 3 month life expectancy",
                "criterions": [
                    {
                        "exact_snippets": "Less than 3 month life expectancy",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "month"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Less than 3 month life expectancy",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "month"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of interstitial lung disease (ILD) or a history of (non-infectious) pneumonitis that required oral or IV steroids (other than Chronic Obstructive Pulmonary Disease [COPD] exacerbation) or current pneumonitis or current evidence of ILD",
                "criterions": [
                    {
                        "exact_snippets": "History of interstitial lung disease (ILD)",
                        "criterion": "interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of (non-infectious) pneumonitis that required oral or IV steroids",
                        "criterion": "(non-infectious) pneumonitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of (non-infectious) pneumonitis that required oral or IV steroids",
                        "criterion": "(non-infectious) pneumonitis",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "oral or IV steroids"
                        }
                    },
                    {
                        "exact_snippets": "current pneumonitis",
                        "criterion": "pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "current evidence of ILD",
                        "criterion": "interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "history of (non-infectious) pneumonitis that required oral or IV steroids",
                                "criterion": "(non-infectious) pneumonitis",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "history of (non-infectious) pneumonitis that required oral or IV steroids",
                                "criterion": "(non-infectious) pneumonitis",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "oral or IV steroids"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "History of interstitial lung disease (ILD)",
                        "criterion": "interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "current pneumonitis",
                        "criterion": "pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "current evidence of ILD",
                        "criterion": "interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs), any replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed",
                "criterions": [
                    {
                        "exact_snippets": "Active autoimmune disease that has required systemic treatment in past 2 years",
                        "criterion": "active autoimmune disease",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed",
                        "criterion": "replacement therapy",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Active autoimmune disease that has required systemic treatment in past 2 years",
                                    "criterion": "active autoimmune disease",
                                    "requirement": {
                                        "requirement_type": "treatment history",
                                        "expected_value": {
                                            "operator": "=",
                                            "value": 2,
                                            "unit": "years"
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed",
                                        "criterion": "replacement therapy",
                                        "requirement": {
                                            "requirement_type": "allowance",
                                            "expected_value": true
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Previous allogeneic tissue/solid organ transplant",
                "criterions": [
                    {
                        "exact_snippets": "Previous allogeneic tissue/solid organ transplant",
                        "criterion": "allogeneic tissue/solid organ transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Previous allogeneic tissue/solid organ transplant",
                    "criterion": "allogeneic tissue/solid organ transplant",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Active infection requiring therapy",
                "criterions": [
                    {
                        "exact_snippets": "Active infection requiring therapy",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "Active infection requiring therapy",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "treatment necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Active infection requiring therapy",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "Active infection requiring therapy",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "treatment necessity",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ongoing grade ≥ 2 peripheral neuropathy",
                "criterions": [
                    {
                        "exact_snippets": "grade ≥ 2 peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "grade ≥ 2 peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Ongoing",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior treatment with platinum, anti-PD-1, anti-PD-L1/2, anti interleukin-7 receptor-alpha (anti-CD127), Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) modulators",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with platinum",
                        "criterion": "prior treatment with platinum",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... anti-PD-1",
                        "criterion": "prior treatment with anti-PD-1",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... anti-PD-L1/2",
                        "criterion": "prior treatment with anti-PD-L1/2",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... anti interleukin-7 receptor-alpha (anti-CD127)",
                        "criterion": "prior treatment with anti interleukin-7 receptor-alpha (anti-CD127)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) modulators",
                        "criterion": "prior treatment with Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) modulators",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Prior treatment with platinum",
                        "criterion": "prior treatment with platinum",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... anti-PD-1",
                        "criterion": "prior treatment with anti-PD-1",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... anti-PD-L1/2",
                        "criterion": "prior treatment with anti-PD-L1/2",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... anti interleukin-7 receptor-alpha (anti-CD127)",
                        "criterion": "prior treatment with anti interleukin-7 receptor-alpha (anti-CD127)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) modulators",
                        "criterion": "prior treatment with Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) modulators",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the 3 days before randomization:",
                "criterions": [
                    {
                        "exact_snippets": "Chronic use of immunosuppressive agents",
                        "criterion": "use of immunosuppressive agents",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "chronic"
                        }
                    },
                    {
                        "exact_snippets": "systemic corticosteroids",
                        "criterion": "use of systemic corticosteroids",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "chronic"
                        }
                    },
                    {
                        "exact_snippets": "any use in the 3 days before randomization",
                        "criterion": "use of immunosuppressive agents",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "3 days before randomization"
                        }
                    },
                    {
                        "exact_snippets": "any use in the 3 days before randomization",
                        "criterion": "use of systemic corticosteroids",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "3 days before randomization"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Chronic use of immunosuppressive agents",
                                        "criterion": "use of immunosuppressive agents",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": "chronic"
                                        }
                                    },
                                    {
                                        "exact_snippets": "systemic corticosteroids",
                                        "criterion": "use of systemic corticosteroids",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": "chronic"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "any use in the 3 days before randomization",
                                        "criterion": "use of immunosuppressive agents",
                                        "requirement": {
                                            "requirement_type": "timeframe",
                                            "expected_value": "3 days before randomization"
                                        }
                                    },
                                    {
                                        "exact_snippets": "any use in the 3 days before randomization",
                                        "criterion": "use of systemic corticosteroids",
                                        "requirement": {
                                            "requirement_type": "timeframe",
                                            "expected_value": "3 days before randomization"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Corticosteroid use on study for management of pembrolizumab Events of Clinical Interest (ECIs), as pre-medication for the administration of chemotherapies, and/or a pre-medication for contrast allergies/reactions is allowed",
                "criterions": [
                    {
                        "exact_snippets": "Corticosteroid use on study for management of pembrolizumab Events of Clinical Interest (ECIs) ... is allowed",
                        "criterion": "corticosteroid use for pembrolizumab ECIs",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Corticosteroid use ... as pre-medication for the administration of chemotherapies ... is allowed",
                        "criterion": "corticosteroid use as pre-medication for chemotherapies",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Corticosteroid use ... a pre-medication for contrast allergies/reactions is allowed",
                        "criterion": "corticosteroid use as pre-medication for contrast allergies/reactions",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Corticosteroid use on study for management of pembrolizumab Events of Clinical Interest (ECIs) ... is allowed",
                            "criterion": "corticosteroid use for pembrolizumab ECIs",
                            "requirement": {
                                "requirement_type": "allowance",
                                "expected_value": true
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Corticosteroid use ... as pre-medication for the administration of chemotherapies ... is allowed",
                            "criterion": "corticosteroid use as pre-medication for chemotherapies",
                            "requirement": {
                                "requirement_type": "allowance",
                                "expected_value": true
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Corticosteroid use ... a pre-medication for contrast allergies/reactions is allowed",
                            "criterion": "corticosteroid use as pre-medication for contrast allergies/reactions",
                            "requirement": {
                                "requirement_type": "allowance",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Daily prednisone at doses of 5-7.5 mg is allowed as an example of replacement therapy. Equivalent hydrocortisone doses are also permitted if administered as a replacement therapy",
                "criterions": [
                    {
                        "exact_snippets": "Daily prednisone at doses of 5-7.5 mg is allowed",
                        "criterion": "prednisone dose",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "mg"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 7.5,
                                        "unit": "mg"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Equivalent hydrocortisone doses are also permitted",
                        "criterion": "hydrocortisone dose",
                        "requirement": {
                            "requirement_type": "equivalence",
                            "expected_value": "equivalent to 5-7.5 mg of prednisone"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Daily prednisone at doses of 5-7.5 mg is allowed",
                                "criterion": "prednisone dose",
                                "requirement": {
                                    "requirement_type": "range",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 5,
                                                "unit": "mg"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 7.5,
                                                "unit": "mg"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Equivalent hydrocortisone doses are also permitted",
                                "criterion": "hydrocortisone dose",
                                "requirement": {
                                    "requirement_type": "equivalence",
                                    "expected_value": "equivalent to 5-7.5 mg of prednisone"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior use of live vaccines within 30 days before randomization. Examples of live vaccines include, but are not limited to, the following : measles, mumps, rubella, chicken pox, shingles, yellow fever, influenza A virus subtype (H1N1) flu, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine",
                "criterions": [
                    {
                        "exact_snippets": "Prior use of live vaccines within 30 days before randomization",
                        "criterion": "use of live vaccines",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior use of live vaccines within 30 days before randomization",
                        "criterion": "use of live vaccines",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Examples of live vaccines include, but are not limited to, the following : measles",
                                "criterion": "live vaccine type",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "measles"
                                }
                            },
                            {
                                "exact_snippets": "Examples of live vaccines include, but are not limited to, the following : mumps",
                                "criterion": "live vaccine type",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "mumps"
                                }
                            },
                            {
                                "exact_snippets": "Examples of live vaccines include, but are not limited to, the following : rubella",
                                "criterion": "live vaccine type",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "rubella"
                                }
                            },
                            {
                                "exact_snippets": "Examples of live vaccines include, but are not limited to, the following : chicken pox",
                                "criterion": "live vaccine type",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "chicken pox"
                                }
                            },
                            {
                                "exact_snippets": "Examples of live vaccines include, but are not limited to, the following : shingles",
                                "criterion": "live vaccine type",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "shingles"
                                }
                            },
                            {
                                "exact_snippets": "Examples of live vaccines include, but are not limited to, the following : yellow fever",
                                "criterion": "live vaccine type",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "yellow fever"
                                }
                            },
                            {
                                "exact_snippets": "Examples of live vaccines include, but are not limited to, the following : influenza A virus subtype (H1N1) flu",
                                "criterion": "live vaccine type",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "influenza A virus subtype (H1N1) flu"
                                }
                            },
                            {
                                "exact_snippets": "Examples of live vaccines include, but are not limited to, the following : rabies",
                                "criterion": "live vaccine type",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "rabies"
                                }
                            },
                            {
                                "exact_snippets": "Examples of live vaccines include, but are not limited to, the following : Bacillus Calmette-Guerin (BCG)",
                                "criterion": "live vaccine type",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "Bacillus Calmette-Guerin (BCG)"
                                }
                            },
                            {
                                "exact_snippets": "Examples of live vaccines include, but are not limited to, the following : typhoid vaccine",
                                "criterion": "live vaccine type",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "typhoid vaccine"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial",
                "criterions": [
                    {
                        "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                        "criterion": "clinical condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                        "criterion": "psychological condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                        "criterion": "familial condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                        "criterion": "sociological condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                        "criterion": "geographical condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                                "criterion": "clinical condition",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                                "criterion": "compliance with the study protocol and follow-up schedule",
                                "requirement": {
                                    "requirement_type": "potentially hampering",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                                "criterion": "psychological condition",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                                "criterion": "compliance with the study protocol and follow-up schedule",
                                "requirement": {
                                    "requirement_type": "potentially hampering",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                                "criterion": "familial condition",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                                "criterion": "compliance with the study protocol and follow-up schedule",
                                "requirement": {
                                    "requirement_type": "potentially hampering",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                                "criterion": "sociological condition",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                                "criterion": "compliance with the study protocol and follow-up schedule",
                                "requirement": {
                                    "requirement_type": "potentially hampering",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                                "criterion": "geographical condition",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Presence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
                                "criterion": "compliance with the study protocol and follow-up schedule",
                                "requirement": {
                                    "requirement_type": "potentially hampering",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Concurrent treatment with any investigational agent within 4 weeks before randomization",
                "criterions": [
                    {
                        "exact_snippets": "Concurrent treatment with any investigational agent within 4 weeks before randomization",
                        "criterion": "concurrent treatment with investigational agent",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Concurrent treatment with any investigational agent within 4 weeks before randomization",
                    "criterion": "concurrent treatment with investigational agent",
                    "requirement": {
                        "requirement_type": "time frame",
                        "expected_value": {
                            "operator": "<",
                            "value": 4,
                            "unit": "weeks"
                        }
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Extended disease according to the criteria of the Veteran's Administration - Lung Cancer Group (VALG): disease extended beyond a hemithorax and the supraclavicular node area. Pleural involvement will be considered as extended disease",
                "criterions": [
                    {
                        "exact_snippets": "Extended disease according to the criteria of the Veteran's Administration - Lung Cancer Group (VALG)",
                        "criterion": "extended disease",
                        "requirement": {
                            "requirement_type": "criteria",
                            "expected_value": "Veteran's Administration - Lung Cancer Group (VALG)"
                        }
                    },
                    {
                        "exact_snippets": "disease extended beyond a hemithorax",
                        "criterion": "disease extension",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "beyond a hemithorax"
                        }
                    },
                    {
                        "exact_snippets": "disease extended beyond ... the supraclavicular node area",
                        "criterion": "disease extension",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "beyond the supraclavicular node area"
                        }
                    },
                    {
                        "exact_snippets": "Pleural involvement will be considered as extended disease",
                        "criterion": "pleural involvement",
                        "requirement": {
                            "requirement_type": "consideration",
                            "expected_value": "extended disease"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants",
                "criterions": [
                    {
                        "exact_snippets": "International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x ULN",
                        "criterion": "INR or PT",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "unless subject is receiving anticoagulant therapy",
                        "criterion": "anticoagulant therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "as long as PT or PTT is within therapeutic range of intended use of anticoagulants",
                        "criterion": "PT or PTT",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "therapeutic range of intended use of anticoagulants"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "International Normalized Ratio (INR) or Prothrombin Time (PT) \u001f 1.5 x ULN",
                                    "criterion": "INR or PT",
                                    "requirement": {
                                        "requirement_type": "value",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 1.5,
                                            "unit": "x ULN"
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "unless subject is receiving anticoagulant therapy",
                                        "criterion": "anticoagulant therapy",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "unless subject is receiving anticoagulant therapy",
                            "criterion": "anticoagulant therapy",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "as long as PT or PTT is within therapeutic range of intended use of anticoagulants",
                            "criterion": "PT or PTT",
                            "requirement": {
                                "requirement_type": "range",
                                "expected_value": "therapeutic range of intended use of anticoagulants"
                            }
                        }
                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "* Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as a PTT is within therapeutic range of intended use of anticoagulants N.B. Lactate Dehydrogenase (LDH) level assessment is mandatory for randomization",
                "criterions": [
                    {
                        "exact_snippets": "Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN",
                        "criterion": "Activated Partial Thromboplastin Time (aPTT)",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "subject is receiving anticoagulant therapy",
                        "criterion": "anticoagulant therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "a PTT is within therapeutic range of intended use of anticoagulants",
                        "criterion": "a PTT within therapeutic range",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "therapeutic range of intended use of anticoagulants"
                        }
                    },
                    {
                        "exact_snippets": "Lactate Dehydrogenase (LDH) level assessment is mandatory for randomization",
                        "criterion": "Lactate Dehydrogenase (LDH) level assessment",
                        "requirement": {
                            "requirement_type": "mandatory",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Activated Partial Thromboplastin Time (aPTT) \u0010 1.5 x ULN",
                                        "criterion": "Activated Partial Thromboplastin Time (aPTT)",
                                        "requirement": {
                                            "requirement_type": "comparison",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1.5,
                                                "unit": "x ULN"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Lactate Dehydrogenase (LDH) level assessment is mandatory for randomization",
                                        "criterion": "Lactate Dehydrogenase (LDH) level assessment",
                                        "requirement": {
                                            "requirement_type": "mandatory",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "subject is receiving anticoagulant therapy",
                                        "criterion": "anticoagulant therapy",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "a PTT is within therapeutic range of intended use of anticoagulants",
                                        "criterion": "a PTT within therapeutic range",
                                        "requirement": {
                                            "requirement_type": "range",
                                            "expected_value": "therapeutic range of intended use of anticoagulants"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Lactate Dehydrogenase (LDH) level assessment is mandatory for randomization",
                                        "criterion": "Lactate Dehydrogenase (LDH) level assessment",
                                        "requirement": {
                                            "requirement_type": "mandatory",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Known history of Human Immunodeficiency Virus (HIV) (known HIV 1/2 antibodies positive). No known active Hepatitis B or C. Active Hepatitis B is defined as a known positive HBsAg results. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative Hepatitis C Virus (HCV) RNA results greater than the lower limits of detection of the assay",
                "criterions": [
                    {
                        "exact_snippets": "Known history of Human Immunodeficiency Virus (HIV) (known HIV 1/2 antibodies positive)",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No known active Hepatitis B ... known positive HBsAg results",
                        "criterion": "active Hepatitis B",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No known active Hepatitis C ... known positive Hep C Ab result and known quantitative Hepatitis C Virus (HCV) RNA results greater than the lower limits of detection of the assay",
                        "criterion": "active Hepatitis C",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No known active Hepatitis B ... known positive HBsAg results",
                                "criterion": "active Hepatitis B",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "No known active Hepatitis C ... known positive Hep C Ab result and known quantitative Hepatitis C Virus (HCV) RNA results greater than the lower limits of detection of the assay",
                                "criterion": "active Hepatitis C",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Known history of Human Immunodeficiency Virus (HIV) (known HIV 1/2 antibodies positive)",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}