{
    "info": {
        "nct_id": "NCT05245682",
        "official_title": "Early-Phase Open-label Study of Tolinapant and Radiation in Cisplatin-Ineligible Patients With Previously Untreated, Locally Advanced Head and Neck Cancer",
        "inclusion_criteria": "1. Male or Female.\n2. Age ≥18 years.\n3. ECOG performance status ≤1 (see Appendix A).\n4. Patients with histologically or cytologically confirmed diagnosis of HNSCC, previously untreated and locally advanced, for whom definitive or adjuvant radiation is planned but cisplatin chemotherapy is contraindicated.\n\n   For the purposes of trial eligibility, anatomic subsites of HNSCC may include the larynx, oropharynx, hypopharynx, nasopharynx, or unknown primary site presenting with neck lymph nodal disease.\n\n   Patients must have a contraindication to cisplatin as defined below. The scores must be recorded on a CRF:\n\n   Age ≥ 70 with moderate to severe comorbidity, defined as having one or more of the following conditions within 30 days prior to registration:\n   * Modified Charlson Comorbidity Index ≥ 1\n   * ACE-27 Index ≥ 1\n   * G-8 score ≤ 14\n   * CARG Toxicity Score ≥ 30%\n   * CIRS-G Score ≥ 4 -OR-\n\n   Age ≥ 18 with an absolute or relative contraindication to cisplatin, defined as one or more of the following criterion within 30 days prior to registration:\n   * Pre-existing peripheral neuropathy grade ≥ 1;\n   * History of hearing loss, defined as either an existing need of a hearing aid OR moderate hearing loss as defined by the American Speech and Hearing Association (pretreatment audiogram showing 40-55 db HL hearing loss)\n   * Creatinine clearance (CrCl) must be > 30 and < 50 mL/min. For this calculation, use the Cockroft-Gault formula: CrCl = 0.85 (if female)* ((140-Age) / (Serum Creatinine)) * (Weight in kg / 72).\n5. Acceptable organ function, as evidenced by the following laboratory data:\n\n   * Absolute neutrophil count [ANC] ≥ 1,500 cells/l; hemoglobin ≥ 9 g/dl, platelets ≥ 100,000/l.\n   * Serum creatinine ≤ 1.5 mg/dl, or calculated creatinine clearance ≥ 60 ml/min.\n   * Bilirubin ≤ upper limit normal [ULN], alanine aminotransferase [ALT] ≤ 1.5 x ULN and/or aspartate aminotransferase [AST] ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN.\n   * Prothrombin time (PT)/international normalized ratio (INR) ≤ 1.5 x ULN.\n   * Activated partial thromboplastin (aPTT) time ≤ 1.5 x ULN. Amylase and lipase ≤ ULN.\n6. The effects of tolinapant on the developing human fetus are unknown. For this reason and because tolinapant as well as other therapeutic agents used in this trial are known to be teratogenic, females of child-bearing potential (FCBP) must have a negative serum pregnancy test prior to starting therapy.\n7. Female patients of childbearing potential and men must agree to use adequate contraception (at least one highly effective method and one additional method of birth control at the same time or complete abstinence) prior to study entry, for the duration of study participation and for at least 6 months following study drug discontinuation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (if age > 55 years); if the female subject is < 55 years and she has been naturally postmenopausal for > 1 year her reproductive status has to be verified by additional lab tests (< 20 estradiol OR estradiol < 40 with FSH > 40 in women not on estrogen replacement therapy).\n8. Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol specified laboratory tests, other study procedures, and study restrictions.\n9. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients who have had prior radiotherapy to the head and neck region\n2. Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs.\n3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to tolinapant.\n4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n5. Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure (or ejection fraction <50%); or uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive therapy.\n6. Contraindications to radiotherapy (e.g. uncontrolled connective tissue disorder).\n7. Women who are pregnant or breast feeding.\n8. Vulnerable populations including prisoners and adults who are unable to consent.\n9. Known history of human immunodeficiency virus (HIV) infection, or seropositive results consistent with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.\n10. Grade 3 or greater neuropathy.\n11. Known distant metastases (i.e., outside of the neck).\n12. Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol treatment or assessments.\n13. Concurrent second malignancy requiring active therapy.\n14. Patients with a history of allogenic transplant must not have ≥Grade 3 graft-versus-host disease (GVHD) or any clinically significant GVHD requiring systemic immunosuppression.\n15. Systemic corticosteroids >20 mg daily prednisone equivalent (unless patient has been taking a continuous dose for >3 weeks prior to study entry).\n16. Medications known to cause QT prolongation including some antipsychotics (chlorpromazine, haloperidol, droperidol, quetiapine, olanzapine, amisulpride, thioridazine), antiarrhythmics (quinidine, procainamide, disopyramide, flecanide, encainide, sotalol, amiodarone), antidipressants (amitriptyline, doxepin, imipramine, nortriptyline, desipramine), mianserin, citalopram, escitalopram, venlafaxine, bupropion, moclobemide), and antihistamines (diphenhydramine, astemizole, loratadine, terfenadine), macrolide antibiotics (erythromycin, clarithromycin), and antimalarials (chloroquine, hydroxychloroquine, quinine), unless the use of these drugs cannot be avoided.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "2. Age ≥18 years.",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. ECOG performance status ≤1 (see Appendix A).",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status ≤1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status ≤1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Patients with histologically or cytologically confirmed diagnosis of HNSCC, previously untreated and locally advanced, for whom definitive or adjuvant radiation is planned but cisplatin chemotherapy is contraindicated.",
                "criterions": [
                    {
                        "exact_snippets": "histologically or cytologically confirmed diagnosis of HNSCC",
                        "criterion": "HNSCC diagnosis",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "previously untreated",
                        "criterion": "treatment history",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "locally advanced",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    },
                    {
                        "exact_snippets": "definitive or adjuvant radiation is planned",
                        "criterion": "radiation therapy plan",
                        "requirement": {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "cisplatin chemotherapy is contraindicated",
                        "criterion": "cisplatin chemotherapy",
                        "requirement": {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "histologically or cytologically confirmed diagnosis of HNSCC",
                                                "criterion": "HNSCC diagnosis",
                                                "requirement": {
                                                    "requirement_type": "confirmation method",
                                                    "expected_value": [
                                                        "histologically",
                                                        "cytologically"
                                                    ]
                                                }
                                            },
                                            {
                                                "exact_snippets": "previously untreated",
                                                "criterion": "treatment history",
                                                "requirement": {
                                                    "requirement_type": "previous treatment",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "locally advanced",
                                        "criterion": "cancer stage",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": "locally advanced"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "definitive or adjuvant radiation is planned",
                                "criterion": "radiation therapy plan",
                                "requirement": {
                                    "requirement_type": "planned",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "cisplatin chemotherapy is contraindicated",
                        "criterion": "cisplatin chemotherapy",
                        "requirement": {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "For the purposes of trial eligibility, anatomic subsites of HNSCC may include the larynx, oropharynx, hypopharynx, nasopharynx, or unknown primary site presenting with neck lymph nodal disease.",
                "criterions": [
                    {
                        "exact_snippets": "anatomic subsites of HNSCC may include the larynx",
                        "criterion": "anatomic subsite of HNSCC",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "larynx"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "anatomic subsites of HNSCC may include the ... oropharynx",
                        "criterion": "anatomic subsite of HNSCC",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "oropharynx"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "anatomic subsites of HNSCC may include the ... hypopharynx",
                        "criterion": "anatomic subsite of HNSCC",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "hypopharynx"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "anatomic subsites of HNSCC may include the ... nasopharynx",
                        "criterion": "anatomic subsite of HNSCC",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "nasopharynx"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "anatomic subsites of HNSCC may include the ... unknown primary site presenting with neck lymph nodal disease",
                        "criterion": "anatomic subsite of HNSCC",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "unknown primary site presenting with neck lymph nodal disease"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "anatomic subsites of HNSCC may include the larynx",
                                "criterion": "anatomic subsite of HNSCC",
                                "requirement": {
                                    "requirement_type": "inclusion",
                                    "expected_value": [
                                        "larynx"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "anatomic subsites of HNSCC may include the ... oropharynx",
                                "criterion": "anatomic subsite of HNSCC",
                                "requirement": {
                                    "requirement_type": "inclusion",
                                    "expected_value": [
                                        "oropharynx"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "anatomic subsites of HNSCC may include the ... hypopharynx",
                                "criterion": "anatomic subsite of HNSCC",
                                "requirement": {
                                    "requirement_type": "inclusion",
                                    "expected_value": [
                                        "hypopharynx"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "anatomic subsites of HNSCC may include the ... nasopharynx",
                                "criterion": "anatomic subsite of HNSCC",
                                "requirement": {
                                    "requirement_type": "inclusion",
                                    "expected_value": [
                                        "nasopharynx"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "anatomic subsites of HNSCC may include the ... unknown primary site presenting with neck lymph nodal disease",
                                "criterion": "anatomic subsite of HNSCC",
                                "requirement": {
                                    "requirement_type": "inclusion",
                                    "expected_value": [
                                        "unknown primary site presenting with neck lymph nodal disease"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Patients must have a contraindication to cisplatin as defined below. The scores must be recorded on a CRF:",
                "criterions": [
                    {
                        "exact_snippets": "contraindication to cisplatin",
                        "criterion": "contraindication to cisplatin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "contraindication to cisplatin",
                        "criterion": "contraindication to cisplatin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Age ≥ 70 with moderate to severe comorbidity, defined as having one or more of the following conditions within 30 days prior to registration:",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥ 70",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "moderate to severe comorbidity",
                        "criterion": "comorbidity",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "moderate",
                                "severe"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "having one or more of the following conditions within 30 days prior to registration",
                        "criterion": "conditions within 30 days prior to registration",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Age ≥ 70",
                                "criterion": "age",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "moderate to severe comorbidity",
                                "criterion": "comorbidity",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": [
                                        "moderate",
                                        "severe"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "having one or more of the following conditions within 30 days prior to registration",
                        "criterion": "conditions within 30 days prior to registration",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Modified Charlson Comorbidity Index ≥ 1",
                "criterions": [
                    {
                        "exact_snippets": "Modified Charlson Comorbidity Index ≥ 1",
                        "criterion": "Modified Charlson Comorbidity Index",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Modified Charlson Comorbidity Index ≥ 1",
                        "criterion": "Modified Charlson Comorbidity Index",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ACE-27 Index ≥ 1",
                "criterions": [
                    {
                        "exact_snippets": "ACE-27 Index ≥ 1",
                        "criterion": "ACE-27 Index",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ACE-27 Index ≥ 1",
                        "criterion": "ACE-27 Index",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* G-8 score ≤ 14",
                "criterions": [
                    {
                        "exact_snippets": "G-8 score ≤ 14",
                        "criterion": "G-8 score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "G-8 score ≤ 14",
                        "criterion": "G-8 score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* CARG Toxicity Score ≥ 30%",
                "criterions": [
                    {
                        "exact_snippets": "CARG Toxicity Score ≥ 30%",
                        "criterion": "CARG Toxicity Score",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "CARG Toxicity Score ≥ 30%",
                        "criterion": "CARG Toxicity Score",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* CIRS-G Score ≥ 4 -OR-",
                "criterions": [
                    {
                        "exact_snippets": "CIRS-G Score ≥ 4",
                        "criterion": "CIRS-G Score",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "CIRS-G Score ≥ 4",
                        "criterion": "CIRS-G Score",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Age ≥ 18 with an absolute or relative contraindication to cisplatin, defined as one or more of the following criterion within 30 days prior to registration:",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥ 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "absolute or relative contraindication to cisplatin",
                        "criterion": "contraindication to cisplatin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥ 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "absolute or relative contraindication to cisplatin",
                        "criterion": "contraindication to cisplatin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pre-existing peripheral neuropathy grade ≥ 1;",
                "criterions": [
                    {
                        "exact_snippets": "Pre-existing peripheral neuropathy grade ≥ 1",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Pre-existing peripheral neuropathy grade ≥ 1",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of hearing loss, defined as either an existing need of a hearing aid OR moderate hearing loss as defined by the American Speech and Hearing Association (pretreatment audiogram showing 40-55 db HL hearing loss)",
                "criterions": [
                    {
                        "exact_snippets": "History of hearing loss, defined as either an existing need of a hearing aid",
                        "criterion": "hearing loss",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "moderate hearing loss as defined by the American Speech and Hearing Association (pretreatment audiogram showing 40-55 db HL hearing loss)",
                        "criterion": "moderate hearing loss",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "40-55 db HL"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of hearing loss, defined as either an existing need of a hearing aid",
                                "criterion": "hearing loss",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "moderate hearing loss as defined by the American Speech and Hearing Association (pretreatment audiogram showing 40-55 db HL hearing loss)",
                                "criterion": "moderate hearing loss",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "40-55 db HL"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Creatinine clearance (CrCl) must be > 30 and < 50 mL/min. For this calculation, use the Cockroft-Gault formula: CrCl = 0.85 (if female)* ((140-Age) / (Serum Creatinine)) * (Weight in kg / 72).",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine clearance (CrCl) must be > 30 and < 50 mL/min.",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 30,
                                        "unit": "mL/min"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "mL/min"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Creatinine clearance (CrCl) must be > 30 and < 50 mL/min.",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 30,
                                        "unit": "mL/min"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "mL/min"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Acceptable organ function, as evidenced by the following laboratory data:",
                "criterions": [
                    {
                        "exact_snippets": "Acceptable organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "acceptable"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Acceptable organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "acceptable"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count [ANC] ≥ 1,500 cells/l; hemoglobin ≥ 9 g/dl, platelets ≥ 100,000/l.",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count [ANC] ≥ 1,500 cells/l",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "cells/l"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hemoglobin ≥ 9 g/dl",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets ≥ 100,000/l",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "l"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count [ANC] ≥ 1,500 cells/l",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "cells/l"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hemoglobin ≥ 9 g/dl",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets ≥ 100,000/l",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "l"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Bilirubin ≤ upper limit normal [ULN], alanine aminotransferase [ALT] ≤ 1.5 x ULN and/or aspartate aminotransferase [AST] ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN.",
                "criterions": [
                    {
                        "exact_snippets": "Bilirubin ≤ upper limit normal [ULN]",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase [ALT] ≤ 1.5 x ULN",
                        "criterion": "alanine aminotransferase (ALT) level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "aspartate aminotransferase [AST] ≤ 1.5 x ULN",
                        "criterion": "aspartate aminotransferase (AST) level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alkaline phosphatase ≤ 2.5 x ULN",
                        "criterion": "alkaline phosphatase level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Bilirubin ≤ upper limit normal [ULN]",
                                "criterion": "bilirubin level",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "ULN"
                                    }
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "alanine aminotransferase [ALT] ≤ 1.5 x ULN",
                                        "criterion": "alanine aminotransferase (ALT) level",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1.5,
                                                "unit": "ULN"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "aspartate aminotransferase [AST] ≤ 1.5 x ULN",
                                        "criterion": "aspartate aminotransferase (AST) level",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1.5,
                                                "unit": "ULN"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "alkaline phosphatase ≤ 2.5 x ULN",
                        "criterion": "alkaline phosphatase level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Activated partial thromboplastin (aPTT) time ≤ 1.5 x ULN. Amylase and lipase ≤ ULN.",
                "criterions": [
                    {
                        "exact_snippets": "Activated partial thromboplastin (aPTT) time ≤ 1.5 x ULN",
                        "criterion": "activated partial thromboplastin (aPTT) time",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Amylase and lipase ≤ ULN",
                        "criterion": "amylase",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Amylase and lipase ≤ ULN",
                        "criterion": "lipase",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Activated partial thromboplastin (aPTT) time ≤ 1.5 x ULN",
                        "criterion": "activated partial thromboplastin (aPTT) time",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Amylase and lipase ≤ ULN",
                                "criterion": "amylase",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Amylase and lipase ≤ ULN",
                                "criterion": "lipase",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "ULN"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. The effects of tolinapant on the developing human fetus are unknown. For this reason and because tolinapant as well as other therapeutic agents used in this trial are known to be teratogenic, females of child-bearing potential (FCBP) must have a negative serum pregnancy test prior to starting therapy.",
                "criterions": [
                    {
                        "exact_snippets": "females of child-bearing potential (FCBP) must have a negative serum pregnancy test",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "females of child-bearing potential (FCBP) must have a negative serum pregnancy test",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.",
                "criterions": [
                    {
                        "exact_snippets": "personally signed informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "aware of the neoplastic nature of the disease",
                        "criterion": "awareness of disease nature",
                        "requirement": {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "informed of the procedures to be followed",
                        "criterion": "awareness of procedures",
                        "requirement": {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "informed of ... the experimental nature of the therapy",
                        "criterion": "awareness of experimental nature",
                        "requirement": {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "informed of ... alternatives",
                        "criterion": "awareness of alternatives",
                        "requirement": {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "informed of ... potential risks and discomforts",
                        "criterion": "awareness of risks and discomforts",
                        "requirement": {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "informed of ... potential benefits",
                        "criterion": "awareness of potential benefits",
                        "requirement": {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "informed of ... other pertinent aspects of study participation",
                        "criterion": "awareness of study participation aspects",
                        "requirement": {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "personally signed informed consent",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "aware of the neoplastic nature of the disease",
                                "criterion": "awareness of disease nature",
                                "requirement": {
                                    "requirement_type": "awareness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "informed of the procedures to be followed",
                                "criterion": "awareness of procedures",
                                "requirement": {
                                    "requirement_type": "awareness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "informed of ... the experimental nature of the therapy",
                                "criterion": "awareness of experimental nature",
                                "requirement": {
                                    "requirement_type": "awareness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "informed of ... alternatives",
                                "criterion": "awareness of alternatives",
                                "requirement": {
                                    "requirement_type": "awareness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "informed of ... potential risks and discomforts",
                                "criterion": "awareness of risks and discomforts",
                                "requirement": {
                                    "requirement_type": "awareness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "informed of ... potential benefits",
                                "criterion": "awareness of potential benefits",
                                "requirement": {
                                    "requirement_type": "awareness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "informed of ... other pertinent aspects of study participation",
                                "criterion": "awareness of study participation aspects",
                                "requirement": {
                                    "requirement_type": "awareness",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Patients who have had prior radiotherapy to the head and neck region",
                "criterions": [
                    {
                        "exact_snippets": "prior radiotherapy to the head and neck region",
                        "criterion": "prior radiotherapy",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "head and neck region"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "prior radiotherapy to the head and neck region",
                        "criterion": "prior radiotherapy",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "head and neck region"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to tolinapant.",
                "criterions": [
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to tolinapant.",
                        "criterion": "allergic reactions to compounds similar to tolinapant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to tolinapant.",
                        "criterion": "allergic reactions to compounds similar to tolinapant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... ongoing or active infection",
                        "criterion": "ongoing or active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                        "criterion": "symptomatic congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... unstable angina pectoris",
                        "criterion": "unstable angina pectoris",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                        "criterion": "psychiatric illness/social situations",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would not limit compliance"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... ongoing or active infection",
                                "criterion": "ongoing or active infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                                "criterion": "symptomatic congestive heart failure",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... unstable angina pectoris",
                                "criterion": "unstable angina pectoris",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
                                "criterion": "cardiac arrhythmia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                        "criterion": "psychiatric illness/social situations",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would not limit compliance"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure (or ejection fraction <50%); or uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy",
                        "criterion": "significant cardiovascular disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "angina requiring therapy",
                        "criterion": "angina",
                        "requirement": {
                            "requirement_type": "requirement for therapy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "symptomatic peripheral vascular disease",
                        "criterion": "symptomatic peripheral vascular disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association Class 3 or 4 congestive heart failure",
                        "criterion": "New York Heart Association Class 3 or 4 congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "ejection fraction <50%",
                        "criterion": "ejection fraction",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive therapy",
                        "criterion": "uncontrolled Grade ≥3 hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "diastolic blood pressure ≥100 mmHg",
                        "criterion": "diastolic blood pressure",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "systolic blood pressure ≥160 mmHg",
                        "criterion": "systolic blood pressure",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 160,
                                "unit": "mmHg"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy",
                                "criterion": "significant cardiovascular disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "angina requiring therapy",
                                "criterion": "angina",
                                "requirement": {
                                    "requirement_type": "requirement for therapy",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "symptomatic peripheral vascular disease",
                                "criterion": "symptomatic peripheral vascular disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "New York Heart Association Class 3 or 4 congestive heart failure",
                                "criterion": "New York Heart Association Class 3 or 4 congestive heart failure",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "ejection fraction <50%",
                                "criterion": "ejection fraction",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "%"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive therapy",
                                "criterion": "uncontrolled Grade ≥3 hypertension",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "diastolic blood pressure ≥100 mmHg",
                                        "criterion": "diastolic blood pressure",
                                        "requirement": {
                                            "requirement_type": "value",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 100,
                                                "unit": "mmHg"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "systolic blood pressure ≥160 mmHg",
                                        "criterion": "systolic blood pressure",
                                        "requirement": {
                                            "requirement_type": "value",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 160,
                                                "unit": "mmHg"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Contraindications to radiotherapy (e.g. uncontrolled connective tissue disorder).",
                "criterions": [
                    {
                        "exact_snippets": "Contraindications to radiotherapy (e.g. uncontrolled connective tissue disorder)",
                        "criterion": "contraindications to radiotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Contraindications to radiotherapy (e.g. uncontrolled connective tissue disorder)",
                        "criterion": "contraindications to radiotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Vulnerable populations including prisoners and adults who are unable to consent.",
                "criterions": [
                    {
                        "exact_snippets": "Vulnerable populations including prisoners",
                        "criterion": "vulnerable populations",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "prisoners"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Vulnerable populations including ... adults who are unable to consent",
                        "criterion": "vulnerable populations",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "adults who are unable to consent"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Vulnerable populations including prisoners",
                        "criterion": "vulnerable populations",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "prisoners"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Vulnerable populations including ... adults who are unable to consent",
                        "criterion": "vulnerable populations",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "adults who are unable to consent"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Grade 3 or greater neuropathy.",
                "criterions": [
                    {
                        "exact_snippets": "Grade 3 or greater neuropathy",
                        "criterion": "neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Grade 3 or greater neuropathy",
                        "criterion": "neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Known distant metastases (i.e., outside of the neck).",
                "criterions": [
                    {
                        "exact_snippets": "Known distant metastases (i.e., outside of the neck)",
                        "criterion": "distant metastases",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "outside of the neck"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Known distant metastases (i.e., outside of the neck)",
                        "criterion": "distant metastases",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "outside of the neck"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol treatment or assessments.",
                "criterions": [
                    {
                        "exact_snippets": "Known significant mental illness",
                        "criterion": "mental illness",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "active alcohol or other substance abuse",
                        "criterion": "substance abuse",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Known significant mental illness",
                                "criterion": "mental illness",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "significant"
                                }
                            },
                            {
                                "exact_snippets": "active alcohol or other substance abuse",
                                "criterion": "substance abuse",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "active"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "... predisposes the subject to high risk of noncompliance with the protocol treatment or assessments.",
                        "criterion": "risk of noncompliance",
                        "requirement": {
                            "requirement_type": "predisposition",
                            "expected_value": "high"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Concurrent second malignancy requiring active therapy.",
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                    {
                        "exact_snippets": "Concurrent second malignancy requiring active therapy",
                        "criterion": "second malignancy",
                        "requirement": {
                            "requirement_type": "concurrent",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Concurrent second malignancy requiring active therapy",
                        "criterion": "second malignancy",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "active therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Concurrent second malignancy requiring active therapy",
                        "criterion": "second malignancy",
                        "requirement": {
                            "requirement_type": "concurrent",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Concurrent second malignancy requiring active therapy",
                        "criterion": "second malignancy",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "active therapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "14. Patients with a history of allogenic transplant must not have ≥Grade 3 graft-versus-host disease (GVHD) or any clinically significant GVHD requiring systemic immunosuppression.",
                "criterions": [
                    {
                        "exact_snippets": "history of allogenic transplant",
                        "criterion": "history of allogenic transplant",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "≥Grade 3 graft-versus-host disease (GVHD)",
                        "criterion": "graft-versus-host disease (GVHD)",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "clinically significant GVHD requiring systemic immunosuppression",
                        "criterion": "clinically significant GVHD",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "not requiring systemic immunosuppression"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "history of allogenic transplant",
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                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
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                        {
                            "exact_snippets": "≥Grade 3 graft-versus-host disease (GVHD)",
                            "criterion": "graft-versus-host disease (GVHD)",
                            "requirement": {
                                "requirement_type": "severity",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 3,
                                    "unit": "Grade"
                                }
                            }
                        },
                        {
                            "exact_snippets": "clinically significant GVHD requiring systemic immunosuppression",
                            "criterion": "clinically significant GVHD",
                            "requirement": {
                                "requirement_type": "treatment",
                                "expected_value": "not requiring systemic immunosuppression"
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "16. Medications known to cause QT prolongation including some antipsychotics (chlorpromazine, haloperidol, droperidol, quetiapine, olanzapine, amisulpride, thioridazine), antiarrhythmics (quinidine, procainamide, disopyramide, flecanide, encainide, sotalol, amiodarone), antidipressants (amitriptyline, doxepin, imipramine, nortriptyline, desipramine), mianserin, citalopram, escitalopram, venlafaxine, bupropion, moclobemide), and antihistamines (diphenhydramine, astemizole, loratadine, terfenadine), macrolide antibiotics (erythromycin, clarithromycin), and antimalarials (chloroquine, hydroxychloroquine, quinine), unless the use of these drugs cannot be avoided.",
                "criterions": [
                    {
                        "exact_snippets": "Medications known to cause QT prolongation",
                        "criterion": "medications causing QT prolongation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "antipsychotics (chlorpromazine, haloperidol, droperidol, quetiapine, olanzapine, amisulpride, thioridazine)",
                        "criterion": "antipsychotics",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "antiarrhythmics (quinidine, procainamide, disopyramide, flecanide, encainide, sotalol, amiodarone)",
                        "criterion": "antiarrhythmics",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "antidipressants (amitriptyline, doxepin, imipramine, nortriptyline, desipramine)",
                        "criterion": "antidepressants",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "mianserin, citalopram, escitalopram, venlafaxine, bupropion, moclobemide",
                        "criterion": "specific antidepressants",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "antihistamines (diphenhydramine, astemizole, loratadine, terfenadine)",
                        "criterion": "antihistamines",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "macrolide antibiotics (erythromycin, clarithromycin)",
                        "criterion": "macrolide antibiotics",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "antimalarials (chloroquine, hydroxychloroquine, quinine)",
                        "criterion": "antimalarials",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
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                        {
                            "and_criteria": [
                                {
                                    "and_criteria": [
                                        {
                                            "and_criteria": [
                                                {
                                                    "and_criteria": [
                                                        {
                                                            "and_criteria": [
                                                                {
                                                                    "and_criteria": [
                                                                        {
                                                                            "exact_snippets": "Medications known to cause QT prolongation",
                                                                            "criterion": "medications causing QT prolongation",
                                                                            "requirement": {
                                                                                "requirement_type": "presence",
                                                                                "expected_value": false
                                                                            }
                                                                        },
                                                                        {
                                                                            "exact_snippets": "antipsychotics (chlorpromazine, haloperidol, droperidol, quetiapine, olanzapine, amisulpride, thioridazine)",
                                                                            "criterion": "antipsychotics",
                                                                            "requirement": {
                                                                                "requirement_type": "presence",
                                                                                "expected_value": false
                                                                            }
                                                                        }
                                                                    ]
                                                                },
                                                                {
                                                                    "exact_snippets": "antiarrhythmics (quinidine, procainamide, disopyramide, flecanide, encainide, sotalol, amiodarone)",
                                                                    "criterion": "antiarrhythmics",
                                                                    "requirement": {
                                                                        "requirement_type": "presence",
                                                                        "expected_value": false
                                                                    }
                                                                }
                                                            ]
                                                        },
                                                        {
                                                            "exact_snippets": "antidipressants (amitriptyline, doxepin, imipramine, nortriptyline, desipramine)",
                                                            "criterion": "antidepressants",
                                                            "requirement": {
                                                                "requirement_type": "presence",
                                                                "expected_value": false
                                                            }
                                                        }
                                                    ]
                                                },
                                                {
                                                    "exact_snippets": "mianserin, citalopram, escitalopram, venlafaxine, bupropion, moclobemide",
                                                    "criterion": "specific antidepressants",
                                                    "requirement": {
                                                        "requirement_type": "presence",
                                                        "expected_value": false
                                                    }
                                                }
                                            ]
                                        },
                                        {
                                            "exact_snippets": "antihistamines (diphenhydramine, astemizole, loratadine, terfenadine)",
                                            "criterion": "antihistamines",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": false
                                            }
                                        }
                                    ]
                                },
                                {
                                    "exact_snippets": "macrolide antibiotics (erythromycin, clarithromycin)",
                                    "criterion": "macrolide antibiotics",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            ]
                        },
                        {
                            "exact_snippets": "antimalarials (chloroquine, hydroxychloroquine, quinine)",
                            "criterion": "antimalarials",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": {
                    "exact_snippets": "unless the use of these drugs cannot be avoided",
                    "criterion": "use of medications causing QT prolongation",
                    "requirement": {
                        "requirement_type": "avoidance",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Known history of human immunodeficiency virus (HIV) infection, or seropositive results consistent with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.",
                "criterions": [
                    {
                        "exact_snippets": "Known history of human immunodeficiency virus (HIV) infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "seropositive results consistent with active hepatitis B virus (HBV) infection",
                        "criterion": "active hepatitis B virus (HBV) infection",
                        "requirement": {
                            "requirement_type": "seropositive",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "seropositive results consistent with active hepatitis C virus (HCV) infection",
                        "criterion": "active hepatitis C virus (HCV) infection",
                        "requirement": {
                            "requirement_type": "seropositive",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "and_criteria": [
                            {
                                "exact_snippets": "Known history of human immunodeficiency virus (HIV) infection",
                                "criterion": "HIV infection",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "seropositive results consistent with active hepatitis B virus (HBV) infection",
                                "criterion": "active hepatitis B virus (HBV) infection",
                                "requirement": {
                                    "requirement_type": "seropositive",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "seropositive results consistent with active hepatitis C virus (HCV) infection",
                                "criterion": "active hepatitis C virus (HCV) infection",
                                "requirement": {
                                    "requirement_type": "seropositive",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "1. Male or Female.",
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                    {
                        "exact_snippets": "Male or Female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "Male",
                                "Female"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Male or Female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "Male"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Male or Female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "Female"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serum creatinine ≤ 1.5 mg/dl, or calculated creatinine clearance ≥ 60 ml/min.",
                "criterions": [
                    {
                        "exact_snippets": "Serum creatinine ≤ 1.5 mg/dl",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        }
                    },
                    {
                        "exact_snippets": "calculated creatinine clearance ≥ 60 ml/min",
                        "criterion": "calculated creatinine clearance",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Serum creatinine \u0010.5 mg/dl",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        }
                    },
                    {
                        "exact_snippets": "calculated creatinine clearance \u00060 ml/min",
                        "criterion": "calculated creatinine clearance",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prothrombin time (PT)/international normalized ratio (INR) ≤ 1.5 x ULN.",
                "criterions": [
                    {
                        "exact_snippets": "Prothrombin time (PT)/international normalized ratio (INR) ≤ 1.5 x ULN",
                        "criterion": "Prothrombin time (PT)/international normalized ratio (INR)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prothrombin time (PT)/international normalized ratio (INR) \u0014 1.5 x ULN",
                        "criterion": "Prothrombin time (PT)/international normalized ratio (INR)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Female patients of childbearing potential and men must agree to use adequate contraception (at least one highly effective method and one additional method of birth control at the same time or complete abstinence) prior to study entry, for the duration of study participation and for at least 6 months following study drug discontinuation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (if age > 55 years); if the female subject is < 55 years and she has been naturally postmenopausal for > 1 year her reproductive status has to be verified by additional lab tests (< 20 estradiol OR estradiol < 40 with FSH > 40 in women not on estrogen replacement therapy).",
                "criterions": [
                    {
                        "exact_snippets": "Female patients of childbearing potential",
                        "criterion": "female patients of childbearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "men must agree to use adequate contraception",
                        "criterion": "male contraception agreement",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate contraception (at least one highly effective method and one additional method of birth control at the same time or complete abstinence)",
                        "criterion": "contraception method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "one highly effective method",
                                "one additional method of birth control",
                                "complete abstinence"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "for the duration of study participation and for at least 6 months following study drug discontinuation",
                        "criterion": "contraception duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "for the duration of study participation and for at least 6 months following study drug discontinuation"
                        }
                    },
                    {
                        "exact_snippets": "A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy",
                        "criterion": "hysterectomy or bilateral oophorectomy",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "2) has not been naturally postmenopausal for at least 12 consecutive months (if age > 55 years)",
                        "criterion": "natural postmenopausal status",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "if the female subject is < 55 years and she has been naturally postmenopausal for > 1 year her reproductive status has to be verified by additional lab tests (< 20 estradiol OR estradiol < 40 with FSH > 40 in women not on estrogen replacement therapy)",
                        "criterion": "reproductive status verification",
                        "requirement": {
                            "requirement_type": "verification",
                            "expected_value": "additional lab tests"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol specified laboratory tests, other study procedures, and study restrictions.",
                "criterions": [
                    {
                        "exact_snippets": "Willingness and ability of the subject to comply with scheduled visits",
                        "criterion": "compliance with scheduled visits",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability of the subject to comply with scheduled visits",
                        "criterion": "compliance with scheduled visits",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability of the subject to comply with ... drug administration plan",
                        "criterion": "compliance with drug administration plan",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability of the subject to comply with ... drug administration plan",
                        "criterion": "compliance with drug administration plan",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability of the subject to comply with ... protocol specified laboratory tests",
                        "criterion": "compliance with protocol specified laboratory tests",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability of the subject to comply with ... protocol specified laboratory tests",
                        "criterion": "compliance with protocol specified laboratory tests",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability of the subject to comply with ... other study procedures",
                        "criterion": "compliance with other study procedures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability of the subject to comply with ... other study procedures",
                        "criterion": "compliance with other study procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability of the subject to comply with ... study restrictions",
                        "criterion": "compliance with study restrictions",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willingness and ability of the subject to comply with ... study restrictions",
                        "criterion": "compliance with study restrictions",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "2. Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs.",
                "criterions": [
                    {
                        "exact_snippets": "Patients who are receiving any other investigational agents",
                        "criterion": "receiving investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "an investigational device within 21 days before administration of first dose of study drugs",
                        "criterion": "receiving investigational device",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "an investigational device within 21 days before administration of first dose of study drugs",
                        "criterion": "receiving investigational device",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients who are receiving any other investigational agents",
                                "criterion": "receiving investigational agents",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "an investigational device within 21 days before administration of first dose of study drugs",
                                "criterion": "receiving investigational device",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "an investigational device within 21 days before administration of first dose of study drugs",
                        "criterion": "receiving investigational device",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Women who are pregnant or breast feeding.",
                "criterions": [
                    {
                        "exact_snippets": "Women who are pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Women who are pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "breast feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "15. Systemic corticosteroids >20 mg daily prednisone equivalent (unless patient has been taking a continuous dose for >3 weeks prior to study entry).",
                "criterions": [
                    {
                        "exact_snippets": "Systemic corticosteroids >20 mg daily prednisone equivalent",
                        "criterion": "systemic corticosteroids",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "mg daily prednisone equivalent"
                            }
                        }
                    },
                    {
                        "exact_snippets": "unless patient has been taking a continuous dose for >3 weeks prior to study entry",
                        "criterion": "continuous dose duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Systemic corticosteroids >20 mg daily prednisone equivalent",
                            "criterion": "systemic corticosteroids",
                            "requirement": {
                                "requirement_type": "dosage",
                                "expected_value": {
                                    "operator": ">",
                                    "value": 20,
                                    "unit": "mg daily prednisone equivalent"
                                }
                            }
                        },
                        {
                            "exact_snippets": "unless patient has been taking a continuous dose for >3 weeks prior to study entry",
                            "criterion": "continuous dose duration",
                            "requirement": {
                                "requirement_type": "duration",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 3,
                                    "unit": "weeks"
                                }
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": null
            }
        }
    ],
    "failed_miscellaneous": []
}