{
    "info": {
        "nct_id": "NCT02012231",
        "official_title": "A Phase I/IIa Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of PLX8394 in Patients With Advanced, Unresectable Solid Tumors",
        "inclusion_criteria": "* Age ≥ 18 years\n* Measurable disease by RECIST 1.1 criteria (solid tumors)\n* ECOG performance status of 0-2\n* Life expectancy ≥ 3 months\n* Adequate hematologic, hepatic, and renal function:\n\n  1. Solid Tumors - Absolute neutrophil count ≥ 1.5 × 109/L, Hgb > 9 g/dL, platelet count ≥ 100 × 109/L, AST/ALT ≤ 2.5 × ULN, bilirubin ≤ 2, creatinine ≤ 1.5 × ULN or calculated CrCl >50 mL/min (Cockcroft-Gault formula)\n  2. Hairy Cell Leukemia - Absolute neutrophil count ≤ 1.0 × 109/L, Hgb ≤ 10.0 g/dL or platelet count ≤ 100 × 109/L; AST/ALT ≤ 2.5 × ULN, bilirubin ≤ 2, creatinine ≤ 1.5 × ULN or calculated CrCl >50 mL/min (Cockcroft-Gault formula)\n* Women of child-bearing potential must have a negative serum pregnancy test within 14 days of initiating study drug and must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 6 months after the last dose of study drug. Urine pregnancy testing during the study and in follow-up per country specific requirements. Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 6 months after the last dose of study drug.\n* Completion of previous chemotherapy, immunotherapy, or radiation therapy at least 2 weeks before study drug initiation, with resolution of all associated toxicity (to ≤ Grade 1 or Baseline)\n* Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements\n* Eligibility for medical insurance coverage\n\n  1. DOSE-ESCALATION COHORTS\n* advanced solid tumors that are refractory to standard therapy, have no standard therapy, or are considered by the investigator to be inappropriate for standard therapy\n\n  2. EXTENSION COHORTS\n* Cancers with a BRAF-activating mutation as assessed by a CLIA-certified method\n\n  a. Melanoma\n* unresectable Stage IIIC or Stage IV disease (sub-cohort 1a: BRAF/MEK/ERK inhibitor naïve, sub-cohort 1b: BRAF/MEK/ERK inhibitor pre-treated) b. Non-melanoma Solid Tumors\n* advanced anaplastic thyroid cancer, advanced papillary thyroid cancer, and advanced solid tumors (e.g., colorectal cancer, non-small cell lung cancer, cholangiocarcinoma, etc) that are refractory to standard therapy, relapsed after standard therapy, have no standard therapy, or are considered by the investigator to be inappropriate for standard therapy c. Hairy Cell Leukemia\n* histologically confirmed classical hairy cell leukemia that failed to achieve CR or PR to initial purine analog-based therapy, relapsed ≤ 2 years after purine analog-based therapy, or a history of intolerance to purine analogs\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Extension Cohorts (except 1b) - Previous treatment with a selective BRAF/MEK/EKR inhibitor\n* Symptomatic brain metastases. Patients with untreated brain metastasis ≤ 1 cm can be considered eligible if deemed asymptomatic by the investigator upon consultation with the medical monitor and do not require immediate radiation or steroids. Patients with brain metastasis that is treated and stable for 1 month may be considered eligible if they are asymptomatic and on stable dose of steroids or if they do not require steroids following successful local therapy.\n* Investigational drug use within 28 days (or < 5 half-lives, whichever is shorter) of the first dose of PLX8394\n* Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed) or anticipation of the need for major surgery during the study\n* Uncontrolled intercurrent illness\n* Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Medical Monitor. Examples of the latter include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen. Patients with a completely treated prior malignancy and no evidence of disease for ≥ 2 years are eligible.\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption\n* Baseline mean QTcF ≥ 450 ms (males) or ≥ 470 ms (females)\n* Women who are breast-feeding or pregnant\n* Known chronic HIV, HCV, or HBV infection",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* 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": "* Measurable disease by RECIST 1.1 criteria (solid tumors)",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease by RECIST 1.1 criteria",
                        "criterion": "disease measurability",
                        "requirement": {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    },
                    {
                        "exact_snippets": "solid tumors",
                        "criterion": "tumor type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "solid"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Measurable disease by RECIST 1.1 criteria",
                        "criterion": "disease measurability",
                        "requirement": {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    },
                    {
                        "exact_snippets": "solid tumors",
                        "criterion": "tumor type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "solid"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG performance status of 0-2",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status of 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status of 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy ≥ 3 months",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy ≥ 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy ≥ 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate hematologic, hepatic, and renal function:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate hematologic ... function",
                        "criterion": "hematologic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... hepatic ... function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate hematologic ... function",
                        "criterion": "hematologic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... hepatic ... function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Solid Tumors - Absolute neutrophil count ≥ 1.5 × 109/L, Hgb > 9 g/dL, platelet count ≥ 100 × 109/L, AST/ALT ≤ 2.5 × ULN, bilirubin ≤ 2, creatinine ≤ 1.5 × ULN or calculated CrCl >50 mL/min (Cockcroft-Gault formula)",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count ≥ 1.5 × 109/L",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "× 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hgb > 9 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelet count ≥ 100 × 109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "× 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST/ALT ≤ 2.5 × ULN",
                        "criterion": "AST/ALT levels",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "bilirubin ≤ 2",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine ≤ 1.5 × ULN",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "calculated CrCl >50 mL/min (Cockcroft-Gault formula)",
                        "criterion": "calculated creatinine clearance (CrCl)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Absolute neutrophil count ≥ 1.5 × 109/L",
                                "criterion": "absolute neutrophil count",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1.5,
                                        "unit": "× 10^9/L"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Hgb > 9 g/dL",
                                "criterion": "hemoglobin level",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 9,
                                        "unit": "g/dL"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "platelet count ≥ 100 × 109/L",
                                "criterion": "platelet count",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 100,
                                        "unit": "× 10^9/L"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "AST/ALT ≤ 2.5 × ULN",
                                "criterion": "AST/ALT levels",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "× ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "bilirubin ≤ 2",
                                "criterion": "bilirubin level",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "creatinine ≤ 1.5 × ULN",
                                "criterion": "creatinine level",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "× ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "calculated CrCl >50 mL/min (Cockcroft-Gault formula)",
                                "criterion": "calculated creatinine clearance (CrCl)",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 50,
                                        "unit": "mL/min"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Completion of previous chemotherapy, immunotherapy, or radiation therapy at least 2 weeks before study drug initiation, with resolution of all associated toxicity (to ≤ Grade 1 or Baseline)",
                "criterions": [
                    {
                        "exact_snippets": "Completion of previous chemotherapy",
                        "criterion": "previous chemotherapy",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Completion of previous ... immunotherapy",
                        "criterion": "previous immunotherapy",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Completion of previous ... radiation therapy",
                        "criterion": "previous radiation therapy",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "at least 2 weeks before study drug initiation",
                        "criterion": "time since previous therapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "resolution of all associated toxicity (to ≤ Grade 1 or Baseline)",
                        "criterion": "associated toxicity",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Completion of previous chemotherapy",
                                "criterion": "previous chemotherapy",
                                "requirement": {
                                    "requirement_type": "completion",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Completion of previous ... immunotherapy",
                                "criterion": "previous immunotherapy",
                                "requirement": {
                                    "requirement_type": "completion",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Completion of previous ... radiation therapy",
                                "criterion": "previous radiation therapy",
                                "requirement": {
                                    "requirement_type": "completion",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "at least 2 weeks before study drug initiation",
                        "criterion": "time since previous therapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "resolution of all associated toxicity (to ≤ Grade 1 or Baseline)",
                        "criterion": "associated toxicity",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eligibility for medical insurance coverage",
                "criterions": [
                    {
                        "exact_snippets": "Eligibility for medical insurance coverage",
                        "criterion": "medical insurance coverage",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eligibility for medical insurance coverage",
                        "criterion": "medical insurance coverage",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. DOSE-ESCALATION COHORTS",
                "criterions": [
                    {
                        "exact_snippets": "DOSE-ESCALATION COHORTS",
                        "criterion": "dose-escalation cohorts",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "DOSE-ESCALATION COHORTS",
                        "criterion": "dose-escalation cohorts",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* advanced solid tumors that are refractory to standard therapy, have no standard therapy, or are considered by the investigator to be inappropriate for standard therapy",
                "criterions": [
                    {
                        "exact_snippets": "advanced solid tumors",
                        "criterion": "solid tumors",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    },
                    {
                        "exact_snippets": "refractory to standard therapy",
                        "criterion": "response to standard therapy",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": "refractory"
                        }
                    },
                    {
                        "exact_snippets": "no standard therapy",
                        "criterion": "availability of standard therapy",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "considered by the investigator to be inappropriate for standard therapy",
                        "criterion": "appropriateness for standard therapy",
                        "requirement": {
                            "requirement_type": "appropriateness",
                            "expected_value": "inappropriate"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "advanced solid tumors",
                        "criterion": "solid tumors",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "refractory to standard therapy",
                                "criterion": "response to standard therapy",
                                "requirement": {
                                    "requirement_type": "response",
                                    "expected_value": "refractory"
                                }
                            },
                            {
                                "exact_snippets": "no standard therapy",
                                "criterion": "availability of standard therapy",
                                "requirement": {
                                    "requirement_type": "availability",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "considered by the investigator to be inappropriate for standard therapy",
                                "criterion": "appropriateness for standard therapy",
                                "requirement": {
                                    "requirement_type": "appropriateness",
                                    "expected_value": "inappropriate"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. EXTENSION COHORTS",
                "criterions": [
                    {
                        "exact_snippets": "EXTENSION COHORTS",
                        "criterion": "extension cohorts",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "EXTENSION COHORTS",
                        "criterion": "extension cohorts",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Cancers with a BRAF-activating mutation as assessed by a CLIA-certified method",
                "criterions": [
                    {
                        "exact_snippets": "Cancers with a BRAF-activating mutation",
                        "criterion": "BRAF-activating mutation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "as assessed by a CLIA-certified method",
                        "criterion": "CLIA-certified method",
                        "requirement": {
                            "requirement_type": "assessment method",
                            "expected_value": "CLIA-certified"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Cancers with a BRAF-activating mutation",
                        "criterion": "BRAF-activating mutation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "as assessed by a CLIA-certified method",
                        "criterion": "CLIA-certified method",
                        "requirement": {
                            "requirement_type": "assessment method",
                            "expected_value": "CLIA-certified"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "a. Melanoma",
                "criterions": [
                    {
                        "exact_snippets": "Melanoma",
                        "criterion": "Melanoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Melanoma",
                        "criterion": "Melanoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* unresectable Stage IIIC or Stage IV disease (sub-cohort 1a: BRAF/MEK/ERK inhibitor naïve, sub-cohort 1b: BRAF/MEK/ERK inhibitor pre-treated) b. Non-melanoma Solid Tumors",
                "criterions": [
                    {
                        "exact_snippets": "unresectable Stage IIIC or Stage IV disease",
                        "criterion": "disease stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage IIIC",
                                "Stage IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "unresectable Stage IIIC or Stage IV disease",
                        "criterion": "disease stage",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "sub-cohort 1a: BRAF/MEK/ERK inhibitor naïve",
                        "criterion": "BRAF/MEK/ERK inhibitor status",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": "naïve"
                        }
                    },
                    {
                        "exact_snippets": "sub-cohort 1b: BRAF/MEK/ERK inhibitor pre-treated",
                        "criterion": "BRAF/MEK/ERK inhibitor status",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": "pre-treated"
                        }
                    },
                    {
                        "exact_snippets": "Non-melanoma Solid Tumors",
                        "criterion": "tumor type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "Non-melanoma Solid Tumors"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "unresectable Stage IIIC or Stage IV disease",
                                                "criterion": "disease stage",
                                                "requirement": {
                                                    "requirement_type": "stage",
                                                    "expected_value": [
                                                        "Stage IIIC",
                                                        "Stage IV"
                                                    ]
                                                }
                                            },
                                            {
                                                "exact_snippets": "unresectable Stage IIIC or Stage IV disease",
                                                "criterion": "disease stage",
                                                "requirement": {
                                                    "requirement_type": "resectability",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "sub-cohort 1a: BRAF/MEK/ERK inhibitor naïve",
                                        "criterion": "BRAF/MEK/ERK inhibitor status",
                                        "requirement": {
                                            "requirement_type": "treatment history",
                                            "expected_value": "naïve"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "unresectable Stage IIIC or Stage IV disease",
                                                "criterion": "disease stage",
                                                "requirement": {
                                                    "requirement_type": "stage",
                                                    "expected_value": [
                                                        "Stage IIIC",
                                                        "Stage IV"
                                                    ]
                                                }
                                            },
                                            {
                                                "exact_snippets": "unresectable Stage IIIC or Stage IV disease",
                                                "criterion": "disease stage",
                                                "requirement": {
                                                    "requirement_type": "resectability",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "sub-cohort 1b: BRAF/MEK/ERK inhibitor pre-treated",
                                        "criterion": "BRAF/MEK/ERK inhibitor status",
                                        "requirement": {
                                            "requirement_type": "treatment history",
                                            "expected_value": "pre-treated"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Non-melanoma Solid Tumors",
                        "criterion": "tumor type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "Non-melanoma Solid Tumors"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* advanced anaplastic thyroid cancer, advanced papillary thyroid cancer, and advanced solid tumors (e.g., colorectal cancer, non-small cell lung cancer, cholangiocarcinoma, etc) that are refractory to standard therapy, relapsed after standard therapy, have no standard therapy, or are considered by the investigator to be inappropriate for standard therapy c. Hairy Cell Leukemia",
                "criterions": [
                    {
                        "exact_snippets": "advanced anaplastic thyroid cancer",
                        "criterion": "anaplastic thyroid cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    },
                    {
                        "exact_snippets": "advanced papillary thyroid cancer",
                        "criterion": "papillary thyroid cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    },
                    {
                        "exact_snippets": "advanced solid tumors (e.g., colorectal cancer, non-small cell lung cancer, cholangiocarcinoma, etc)",
                        "criterion": "solid tumors",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    },
                    {
                        "exact_snippets": "refractory to standard therapy",
                        "criterion": "response to standard therapy",
                        "requirement": {
                            "requirement_type": "refractory",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "relapsed after standard therapy",
                        "criterion": "response to standard therapy",
                        "requirement": {
                            "requirement_type": "relapsed",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "have no standard therapy",
                        "criterion": "availability of standard therapy",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "considered by the investigator to be inappropriate for standard therapy",
                        "criterion": "appropriateness for standard therapy",
                        "requirement": {
                            "requirement_type": "appropriateness",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Hairy Cell Leukemia",
                        "criterion": "Hairy Cell Leukemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "advanced anaplastic thyroid cancer",
                                                "criterion": "anaplastic thyroid cancer",
                                                "requirement": {
                                                    "requirement_type": "stage",
                                                    "expected_value": "advanced"
                                                }
                                            },
                                            {
                                                "or_criteria": [
                                                    {
                                                        "exact_snippets": "refractory to standard therapy",
                                                        "criterion": "response to standard therapy",
                                                        "requirement": {
                                                            "requirement_type": "refractory",
                                                            "expected_value": true
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "relapsed after standard therapy",
                                                        "criterion": "response to standard therapy",
                                                        "requirement": {
                                                            "requirement_type": "relapsed",
                                                            "expected_value": true
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "have no standard therapy",
                                                        "criterion": "availability of standard therapy",
                                                        "requirement": {
                                                            "requirement_type": "availability",
                                                            "expected_value": false
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "considered by the investigator to be inappropriate for standard therapy",
                                                        "criterion": "appropriateness for standard therapy",
                                                        "requirement": {
                                                            "requirement_type": "appropriateness",
                                                            "expected_value": false
                                                        }
                                                    }
                                                ]
                                            }
                                        ]
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "advanced papillary thyroid cancer",
                                                "criterion": "papillary thyroid cancer",
                                                "requirement": {
                                                    "requirement_type": "stage",
                                                    "expected_value": "advanced"
                                                }
                                            },
                                            {
                                                "or_criteria": [
                                                    {
                                                        "exact_snippets": "refractory to standard therapy",
                                                        "criterion": "response to standard therapy",
                                                        "requirement": {
                                                            "requirement_type": "refractory",
                                                            "expected_value": true
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "relapsed after standard therapy",
                                                        "criterion": "response to standard therapy",
                                                        "requirement": {
                                                            "requirement_type": "relapsed",
                                                            "expected_value": true
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "have no standard therapy",
                                                        "criterion": "availability of standard therapy",
                                                        "requirement": {
                                                            "requirement_type": "availability",
                                                            "expected_value": false
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "considered by the investigator to be inappropriate for standard therapy",
                                                        "criterion": "appropriateness for standard therapy",
                                                        "requirement": {
                                                            "requirement_type": "appropriateness",
                                                            "expected_value": false
                                                        }
                                                    }
                                                ]
                                            }
                                        ]
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "advanced solid tumors (e.g., colorectal cancer, non-small cell lung cancer, cholangiocarcinoma, etc)",
                                                "criterion": "solid tumors",
                                                "requirement": {
                                                    "requirement_type": "stage",
                                                    "expected_value": "advanced"
                                                }
                                            },
                                            {
                                                "or_criteria": [
                                                    {
                                                        "exact_snippets": "refractory to standard therapy",
                                                        "criterion": "response to standard therapy",
                                                        "requirement": {
                                                            "requirement_type": "refractory",
                                                            "expected_value": true
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "relapsed after standard therapy",
                                                        "criterion": "response to standard therapy",
                                                        "requirement": {
                                                            "requirement_type": "relapsed",
                                                            "expected_value": true
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "have no standard therapy",
                                                        "criterion": "availability of standard therapy",
                                                        "requirement": {
                                                            "requirement_type": "availability",
                                                            "expected_value": false
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "considered by the investigator to be inappropriate for standard therapy",
                                                        "criterion": "appropriateness for standard therapy",
                                                        "requirement": {
                                                            "requirement_type": "appropriateness",
                                                            "expected_value": false
                                                        }
                                                    }
                                                ]
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Hairy Cell Leukemia",
                                "criterion": "Hairy Cell Leukemia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Hairy Cell Leukemia",
                        "criterion": "Hairy Cell Leukemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* histologically confirmed classical hairy cell leukemia that failed to achieve CR or PR to initial purine analog-based therapy, relapsed ≤ 2 years after purine analog-based therapy, or a history of intolerance to purine analogs",
                "criterions": [
                    {
                        "exact_snippets": "histologically confirmed classical hairy cell leukemia",
                        "criterion": "classical hairy cell leukemia",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "failed to achieve CR or PR to initial purine analog-based therapy",
                        "criterion": "response to initial purine analog-based therapy",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": [
                                "CR",
                                "PR"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "relapsed ≤ 2 years after purine analog-based therapy",
                        "criterion": "relapse after purine analog-based therapy",
                        "requirement": {
                            "requirement_type": "time since therapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "history of intolerance to purine analogs",
                        "criterion": "intolerance to purine analogs",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": "intolerance"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "histologically confirmed classical hairy cell leukemia",
                        "criterion": "classical hairy cell leukemia",
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                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "not_criteria": {
                                    "exact_snippets": "failed to achieve CR or PR to initial purine analog-based therapy",
                                    "criterion": "response to initial purine analog-based therapy",
                                    "requirement": {
                                        "requirement_type": "response",
                                        "expected_value": [
                                            "CR",
                                            "PR"
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "relapsed ≤ 2 years after purine analog-based therapy",
                                "criterion": "relapse after purine analog-based therapy",
                                "requirement": {
                                    "requirement_type": "time since therapy",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "history of intolerance to purine analogs",
                                "criterion": "intolerance to purine analogs",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": "intolerance"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements",
                "criterions": [
                    {
                        "exact_snippets": "Willingness ... to provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ability to provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness ... to comply with all study requirements",
                        "criterion": "compliance with study requirements",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Willingness ... to provide written informed consent",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "ability to provide written informed consent",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "ability",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "willingness ... to comply with all study requirements",
                        "criterion": "compliance with study requirements",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Extension Cohorts (except 1b) - Previous treatment with a selective BRAF/MEK/EKR inhibitor",
                "criterions": [
                    {
                        "exact_snippets": "Previous treatment with a selective BRAF/MEK/EKR inhibitor",
                        "criterion": "previous treatment",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "selective BRAF inhibitor",
                                "selective MEK inhibitor",
                                "selective EKR inhibitor"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Extension Cohorts (except 1b)",
                    "criterion": "extension cohort",
                    "requirement": {
                        "requirement_type": "exclusion",
                        "expected_value": "1b"
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Previous treatment with a selective BRAF/MEK/EKR inhibitor",
                    "criterion": "previous treatment",
                    "requirement": {
                        "requirement_type": "treatment type",
                        "expected_value": [
                            "selective BRAF inhibitor",
                            "selective MEK inhibitor",
                            "selective EKR inhibitor"
                        ]
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled intercurrent illness",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness",
                        "criterion": "intercurrent illness",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Uncontrolled intercurrent illness",
                    "criterion": "intercurrent illness",
                    "requirement": {
                        "requirement_type": "control status",
                        "expected_value": "uncontrolled"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Medical Monitor. Examples of the latter include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen. Patients with a completely treated prior malignancy and no evidence of disease for ≥ 2 years are eligible.",
                "criterions": [
                    {
                        "exact_snippets": "Active secondary malignancy",
                        "criterion": "active secondary malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "completely treated prior malignancy and no evidence of disease for ≥ 2 years",
                        "criterion": "prior malignancy",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "completely treated"
                        }
                    },
                    {
                        "exact_snippets": "completely treated prior malignancy and no evidence of disease for ≥ 2 years",
                        "criterion": "prior malignancy",
                        "requirement": {
                            "requirement_type": "evidence of disease",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "completely treated prior malignancy and no evidence of disease for ≥ 2 years",
                        "criterion": "prior malignancy",
                        "requirement": {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "and_criteria": [
                                        {
                                            "not_criteria": {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "Active secondary malignancy",
                                                        "criterion": "active secondary malignancy",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": false
                                                        }
                                                    },
                                                    {
                                                        "or_criteria": [
                                                            {
                                                                "exact_snippets": "Examples of the latter include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen.",
                                                                "criterion": "secondary malignancy type",
                                                                "requirement": {
                                                                    "requirement_type": "type",
                                                                    "expected_value": [
                                                                        "basal cell carcinoma of the skin",
                                                                        "squamous cell carcinoma of the skin",
                                                                        "in-situ carcinoma of the cervix",
                                                                        "isolated elevation of prostate-specific antigen"
                                                                    ]
                                                                }
                                                            },
                                                            {
                                                                "exact_snippets": "unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Medical Monitor",
                                                                "criterion": "medical monitor approval",
                                                                "requirement": {
                                                                    "requirement_type": "approval",
                                                                    "expected_value": true
                                                                }
                                                            }
                                                        ]
                                                    }
                                                ]
                                            }
                                        }
                                    ]
                                }
                            ]
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "completely treated prior malignancy and no evidence of disease for ≥ 2 years",
                                        "criterion": "prior malignancy",
                                        "requirement": {
                                            "requirement_type": "treatment status",
                                            "expected_value": "completely treated"
                                        }
                                    },
                                    {
                                        "exact_snippets": "completely treated prior malignancy and no evidence of disease for ≥ 2 years",
                                        "criterion": "prior malignancy",
                                        "requirement": {
                                            "requirement_type": "evidence of disease",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "completely treated prior malignancy and no evidence of disease for ≥ 2 years",
                                        "criterion": "prior malignancy",
                                        "requirement": {
                                            "requirement_type": "disease-free duration",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "years"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption",
                "criterions": [
                    {
                        "exact_snippets": "Refractory nausea and vomiting",
                        "criterion": "refractory nausea and vomiting",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "malabsorption",
                        "criterion": "malabsorption",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "external biliary shunt",
                        "criterion": "external biliary shunt",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "significant bowel resection",
                        "criterion": "significant bowel resection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Refractory nausea and vomiting",
                                "criterion": "refractory nausea and vomiting",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Refractory nausea and vomiting",
                                "criterion": "refractory nausea and vomiting",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "refractory"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "malabsorption",
                        "criterion": "malabsorption",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "external biliary shunt",
                        "criterion": "external biliary shunt",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "significant bowel resection",
                        "criterion": "significant bowel resection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women who are breast-feeding or pregnant",
                "criterions": [
                    {
                        "exact_snippets": "Women who are breast-feeding",
                        "criterion": "breast-feeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Women who are ... pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Women who are breast-feeding",
                        "criterion": "breast-feeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Women who are ... pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known chronic HIV, HCV, or HBV infection",
                "criterions": [
                    {
                        "exact_snippets": "Known chronic HIV",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known chronic HIV",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "chronicity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HCV",
                        "criterion": "HCV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HBV infection",
                        "criterion": "HBV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Known chronic HIV",
                                "criterion": "HIV infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Known chronic HIV",
                                "criterion": "HIV infection",
                                "requirement": {
                                    "requirement_type": "chronicity",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "HCV",
                        "criterion": "HCV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HBV infection",
                        "criterion": "HBV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "2. Hairy Cell Leukemia - Absolute neutrophil count ≤ 1.0 × 109/L, Hgb ≤ 10.0 g/dL or platelet count ≤ 100 × 109/L; AST/ALT ≤ 2.5 × ULN, bilirubin ≤ 2, creatinine ≤ 1.5 × ULN or calculated CrCl >50 mL/min (Cockcroft-Gault formula)",
                "criterions": [
                    {
                        "exact_snippets": "Hairy Cell Leukemia",
                        "criterion": "Hairy Cell Leukemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Absolute neutrophil count ≤ 1.0 × 109/L",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.0,
                                "unit": "× 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hgb ≤ 10.0 g/dL",
                        "criterion": "hemoglobin (Hgb)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10.0,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelet count ≤ 100 × 109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "× 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST/ALT ≤ 2.5 × ULN",
                        "criterion": "AST/ALT",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "bilirubin ≤ 2",
                        "criterion": "bilirubin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine ≤ 1.5 × ULN",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "calculated CrCl >50 mL/min (Cockcroft-Gault formula)",
                        "criterion": "calculated creatinine clearance (CrCl)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "and_criteria": [
                                                                    {
                                                                        "and_criteria": [
                                                                            {
                                                                                "exact_snippets": "Hairy Cell Leukemia",
                                                                                "criterion": "Hairy Cell Leukemia",
                                                                                "requirement": {
                                                                                    "requirement_type": "presence",
                                                                                    "expected_value": true
                                                                                }
                                                                            },
                                                                            {
                                                                                "exact_snippets": "absolute neutrophil count ≤ 1.0 × 109/L",
                                                                                "criterion": "absolute neutrophil count",
                                                                                "requirement": {
                                                                                    "requirement_type": "quantity",
                                                                                    "expected_value": {
                                                                                        "operator": "<=",
                                                                                        "value": 1.0,
                                                                                        "unit": "× 10^9/L"
                                                                                    }
                                                                                }
                                                                            }
                                                                        ]
                                                                    },
                                                                    {
                                                                        "or_criteria": [
                                                                            {
                                                                                "exact_snippets": "Hgb ≤ 10.0 g/dL",
                                                                                "criterion": "hemoglobin (Hgb)",
                                                                                "requirement": {
                                                                                    "requirement_type": "quantity",
                                                                                    "expected_value": {
                                                                                        "operator": "<=",
                                                                                        "value": 10.0,
                                                                                        "unit": "g/dL"
                                                                                    }
                                                                                }
                                                                            },
                                                                            {
                                                                                "exact_snippets": "platelet count ≤ 100 × 109/L",
                                                                                "criterion": "platelet count",
                                                                                "requirement": {
                                                                                    "requirement_type": "quantity",
                                                                                    "expected_value": {
                                                                                        "operator": "<=",
                                                                                        "value": 100,
                                                                                        "unit": "× 10^9/L"
                                                                                    }
                                                                                }
                                                                            }
                                                                        ]
                                                                    }
                                                                ]
                                                            },
                                                            {
                                                                "exact_snippets": "AST/ALT ≤ 2.5 × ULN",
                                                                "criterion": "AST/ALT",
                                                                "requirement": {
                                                                    "requirement_type": "quantity",
                                                                    "expected_value": {
                                                                        "operator": "<=",
                                                                        "value": 2.5,
                                                                        "unit": "× ULN"
                                                                    }
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "bilirubin ≤ 2",
                                                        "criterion": "bilirubin",
                                                        "requirement": {
                                                            "requirement_type": "quantity",
                                                            "expected_value": {
                                                                "operator": "<=",
                                                                "value": 2,
                                                                "unit": "N/A"
                                                            }
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "or_criteria": [
                                                    {
                                                        "exact_snippets": "creatinine ≤ 1.5 × ULN",
                                                        "criterion": "creatinine",
                                                        "requirement": {
                                                            "requirement_type": "quantity",
                                                            "expected_value": {
                                                                "operator": "<=",
                                                                "value": 1.5,
                                                                "unit": "× ULN"
                                                            }
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "calculated CrCl >50 mL/min (Cockcroft-Gault formula)",
                                                        "criterion": "calculated creatinine clearance (CrCl)",
                                                        "requirement": {
                                                            "requirement_type": "quantity",
                                                            "expected_value": {
                                                                "operator": ">",
                                                                "value": 50,
                                                                "unit": "mL/min"
                                                            }
                                                        }
                                                    }
                                                ]
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "AST/ALT ≤ 2.5 × ULN",
                                "criterion": "AST/ALT",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "× ULN"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "bilirubin ≤ 2",
                        "criterion": "bilirubin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women of child-bearing potential must have a negative serum pregnancy test within 14 days of initiating study drug and must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 6 months after the last dose of study drug. Urine pregnancy testing during the study and in follow-up per country specific requirements. Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 6 months after the last dose of study drug.",
                "criterions": [
                    {
                        "exact_snippets": "Women of child-bearing potential",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Women of child-bearing potential",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "reproductive status",
                            "expected_value": "child-bearing potential"
                        }
                    },
                    {
                        "exact_snippets": "negative serum pregnancy test within 14 days of initiating study drug",
                        "criterion": "serum pregnancy test result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "negative serum pregnancy test within 14 days of initiating study drug",
                        "criterion": "serum pregnancy test result",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 14 days of initiating study drug"
                        }
                    },
                    {
                        "exact_snippets": "agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 6 months after the last dose of study drug",
                        "criterion": "birth control usage",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 6 months after the last dose of study drug",
                        "criterion": "birth control usage",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "from the time of the negative pregnancy test up to 6 months after the last dose of study drug"
                        }
                    },
                    {
                        "exact_snippets": "Urine pregnancy testing during the study and in follow-up per country specific requirements",
                        "criterion": "urine pregnancy testing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "during the study and in follow-up"
                        }
                    },
                    {
                        "exact_snippets": "Urine pregnancy testing during the study and in follow-up per country specific requirements",
                        "criterion": "urine pregnancy testing",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": "per country specific requirements"
                        }
                    },
                    {
                        "exact_snippets": "Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 6 months after the last dose of study drug",
                        "criterion": "birth control usage for fertile men",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 6 months after the last dose of study drug",
                        "criterion": "birth control usage for fertile men",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "while on study drug and up to 6 months after the last dose of study drug"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Symptomatic brain metastases. Patients with untreated brain metastasis ≤ 1 cm can be considered eligible if deemed asymptomatic by the investigator upon consultation with the medical monitor and do not require immediate radiation or steroids. Patients with brain metastasis that is treated and stable for 1 month may be considered eligible if they are asymptomatic and on stable dose of steroids or if they do not require steroids following successful local therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Symptomatic brain metastases.",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "untreated brain metastasis ≤ 1 cm ... deemed asymptomatic ... do not require immediate radiation or steroids.",
                        "criterion": "untreated brain metastasis",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "untreated brain metastasis ≤ 1 cm ... deemed asymptomatic ... do not require immediate radiation or steroids.",
                        "criterion": "untreated brain metastasis",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "untreated brain metastasis ≤ 1 cm ... deemed asymptomatic ... do not require immediate radiation or steroids.",
                        "criterion": "untreated brain metastasis",
                        "requirement": {
                            "requirement_type": "immediate radiation requirement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "untreated brain metastasis ≤ 1 cm ... deemed asymptomatic ... do not require immediate radiation or steroids.",
                        "criterion": "untreated brain metastasis",
                        "requirement": {
                            "requirement_type": "immediate steroids requirement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "brain metastasis that is treated and stable for 1 month ... asymptomatic ... on stable dose of steroids",
                        "criterion": "treated brain metastasis",
                        "requirement": {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    },
                    {
                        "exact_snippets": "brain metastasis that is treated and stable for 1 month ... asymptomatic ... on stable dose of steroids",
                        "criterion": "treated brain metastasis",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "brain metastasis that is treated and stable for 1 month ... asymptomatic ... on stable dose of steroids",
                        "criterion": "treated brain metastasis",
                        "requirement": {
                            "requirement_type": "steroids dose stability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "brain metastasis that is treated and stable for 1 month ... asymptomatic ... do not require steroids following successful local therapy.",
                        "criterion": "treated brain metastasis",
                        "requirement": {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    },
                    {
                        "exact_snippets": "brain metastasis that is treated and stable for 1 month ... asymptomatic ... do not require steroids following successful local therapy.",
                        "criterion": "treated brain metastasis",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "brain metastasis that is treated and stable for 1 month ... asymptomatic ... do not require steroids following successful local therapy.",
                        "criterion": "treated brain metastasis",
                        "requirement": {
                            "requirement_type": "steroids requirement post-therapy",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Symptomatic brain metastases.",
                                "criterion": "brain metastases",
                                "requirement": {
                                    "requirement_type": "symptomatic",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "untreated brain metastasis \u0010 1 cm ... deemed asymptomatic ... do not require immediate radiation or steroids.",
                                "criterion": "untreated brain metastasis",
                                "requirement": {
                                    "requirement_type": "size",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "cm"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "untreated brain metastasis \u0010 1 cm ... deemed asymptomatic ... do not require immediate radiation or steroids.",
                                "criterion": "untreated brain metastasis",
                                "requirement": {
                                    "requirement_type": "symptomatic",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "untreated brain metastasis \u0010 1 cm ... deemed asymptomatic ... do not require immediate radiation or steroids.",
                                "criterion": "untreated brain metastasis",
                                "requirement": {
                                    "requirement_type": "immediate radiation requirement",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "untreated brain metastasis \u0010 1 cm ... deemed asymptomatic ... do not require immediate radiation or steroids.",
                                "criterion": "untreated brain metastasis",
                                "requirement": {
                                    "requirement_type": "immediate steroids requirement",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "brain metastasis that is treated and stable for 1 month ... asymptomatic ... on stable dose of steroids",
                                "criterion": "treated brain metastasis",
                                "requirement": {
                                    "requirement_type": "stability duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "month"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "brain metastasis that is treated and stable for 1 month ... asymptomatic ... on stable dose of steroids",
                                "criterion": "treated brain metastasis",
                                "requirement": {
                                    "requirement_type": "symptomatic",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "brain metastasis that is treated and stable for 1 month ... asymptomatic ... on stable dose of steroids",
                                "criterion": "treated brain metastasis",
                                "requirement": {
                                    "requirement_type": "steroids dose stability",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "brain metastasis that is treated and stable for 1 month ... asymptomatic ... do not require steroids following successful local therapy.",
                                "criterion": "treated brain metastasis",
                                "requirement": {
                                    "requirement_type": "stability duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "month"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "brain metastasis that is treated and stable for 1 month ... asymptomatic ... do not require steroids following successful local therapy.",
                                "criterion": "treated brain metastasis",
                                "requirement": {
                                    "requirement_type": "symptomatic",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "brain metastasis that is treated and stable for 1 month ... asymptomatic ... do not require steroids following successful local therapy.",
                                "criterion": "treated brain metastasis",
                                "requirement": {
                                    "requirement_type": "steroids requirement post-therapy",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Investigational drug use within 28 days (or < 5 half-lives, whichever is shorter) of the first dose of PLX8394",
                "criterions": [
                    {
                        "exact_snippets": "Investigational drug use within 28 days (or < 5 half-lives, whichever is shorter)",
                        "criterion": "investigational drug use",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 28,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Investigational drug use within 28 days (or < 5 half-lives, whichever is shorter)",
                                "criterion": "investigational drug use",
                                "requirement": {
                                    "requirement_type": "time since last use",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 28,
                                                "unit": "days"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Investigational drug use within 28 days (or < 5 half-lives, whichever is shorter)",
                                "criterion": "investigational drug use",
                                "requirement": {
                                    "requirement_type": "time since last use",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 5,
                                                "unit": "half-lives"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed) or anticipation of the need for major surgery during the study",
                "criterions": [
                    {
                        "exact_snippets": "Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 14 days of initiating study drug",
                        "criterion": "recent major surgical procedure, open biopsy, or significant traumatic injury",
                        "requirement": {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "wound has healed",
                        "criterion": "wound healing",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healed"
                        }
                    },
                    {
                        "exact_snippets": "anticipation of the need for major surgery during the study",
                        "criterion": "anticipated need for major surgery",
                        "requirement": {
                            "requirement_type": "future need",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "not_criteria": {
                                    "not_criteria": {
                                        "exact_snippets": "wound has healed",
                                        "criterion": "wound healing",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "healed"
                                        }
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 14 days of initiating study drug",
                                "criterion": "recent major surgical procedure, open biopsy, or significant traumatic injury",
                                "requirement": {
                                    "requirement_type": "time since occurrence",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Baseline mean QTcF ≥ 450 ms (males) or ≥ 470 ms (females)",
                "criterions": [
                    {
                        "exact_snippets": "Baseline mean QTcF ≥ 450 ms (males)",
                        "criterion": "baseline mean QTcF (males)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Baseline mean QTcF ... ≥ 470 ms (females)",
                        "criterion": "baseline mean QTcF (females)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}