{
    "info": {
        "nct_id": "NCT00403182",
        "official_title": "The CORE Study (Chemotherapy OR Endocrine Treatment First?) A Randomized Study by the Scandinavian Breast Group [CORE]",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have maximum age of 74 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast cancer\n\n  * Metastatic or locally advanced disease\n  * Bilateral breast cancer allowed\n* Measurable or evaluable progressing metastases or local disease\n\n  * No sclerotic bone metastases as only disease\n  * Measurable or evaluable disease not in a previously irradiated area\n* No immediately life-threatening metastatic disease\n* No known HER2/neu positivity, as defined by either of the following:\n\n  * 3+ by immunohistochemistry\n  * HER2-positive by fluorescent in situ hybridization or chromogenic in situ hybridization\n* No known cerebral or leptomeningeal metastases\n* Hormone receptor status:\n\n  * Estrogen and/or progesterone receptor positive tumor\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Postmenopausal, as defined by any of the following:\n\n  * Bilateral oophorectomy and amenorrhea > 3 months\n  * Radiation castration and amenorrhea > 3 months\n  * Spontaneous menopause and amenorrhea > 12 months\n  * Previous hysterectomy and age > 55 years\n* ECOG performance status 0-2\n\n  * Must be ambulant with organ function and performance status adequate for conventional combination chemotherapy\n* No serious hypersensitivity to letrozole or other components of study drug\n* No other prior or concurrent malignancy except for basal cell carcinoma or carcinoma in situ of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior systemic treatment for recurrent or metastatic breast cancer\n* No other concurrent radiotherapy, endocrine therapy, cytotoxic therapy, or experimental therapy for cancer"
    },
    "inclusion_lines": [
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                "line": "Healthy volunteers allowed",
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                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
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                        "exact_snippets": "Must be FEMALE",
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                            "expected_value": "female"
                        }
                    }
                ]
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                    {
                        "exact_snippets": "Must be FEMALE",
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        },
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                        "exact_snippets": "maximum age of 74 Years",
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                                "operator": "<=",
                                "value": 74,
                                "unit": "Years"
                            }
                        }
                    }
                ]
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                    {
                        "exact_snippets": "maximum age of 74 Years",
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                            "expected_value": {
                                "operator": "<=",
                                "value": 74,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
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                "line": "DISEASE CHARACTERISTICS:",
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                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
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                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
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                            "expected_value": "N/A"
                        }
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        },
        {
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                    {
                        "exact_snippets": "Histologically confirmed breast cancer",
                        "criterion": "breast cancer",
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                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            },
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                        "exact_snippets": "Histologically confirmed breast cancer",
                        "criterion": "breast cancer",
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                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            }
        },
        {
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                            "expected_value": true
                        }
                    },
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                    }
                ]
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                        "exact_snippets": "Metastatic",
                        "criterion": "metastatic disease",
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                        }
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                ]
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        },
        {
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                        "exact_snippets": "Bilateral breast cancer allowed",
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        },
        {
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                "line": "* Measurable or evaluable progressing metastases or local disease",
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                    {
                        "exact_snippets": "Measurable or evaluable progressing metastases",
                        "criterion": "metastases",
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                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Measurable or evaluable progressing metastases",
                        "criterion": "metastases",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Measurable or evaluable ... local disease",
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                ]
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                                "exact_snippets": "Measurable or evaluable progressing metastases",
                                "criterion": "metastases",
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                                }
                            }
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                    {
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                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No sclerotic bone metastases as only disease",
                "criterions": [
                    {
                        "exact_snippets": "No sclerotic bone metastases",
                        "criterion": "sclerotic bone metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "as only disease",
                        "criterion": "only disease",
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                        }
                    }
                ]
            },
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                    {
                        "exact_snippets": "No sclerotic bone metastases",
                        "criterion": "sclerotic bone metastases",
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                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "as only disease",
                        "criterion": "only disease",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No immediately life-threatening metastatic disease",
                "criterions": [
                    {
                        "exact_snippets": "No immediately life-threatening metastatic disease",
                        "criterion": "metastatic disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "not immediately life-threatening"
                        }
                    }
                ]
            },
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                        "exact_snippets": "No immediately life-threatening metastatic disease",
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                            "requirement_type": "severity",
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No known HER2/neu positivity, as defined by either of the following:",
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                    {
                        "exact_snippets": "No known HER2/neu positivity",
                        "criterion": "HER2/neu status",
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                        }
                    }
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                        "criterion": "immunohistochemistry result",
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                            "requirement_type": "presence",
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                        }
                    },
                    {
                        "exact_snippets": "No known ... leptomeningeal metastases",
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                        }
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                    }
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        },
        {
            "identified_line": {
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                    }
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                    }
                ]
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        },
        {
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        {
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        },
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                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
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                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
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                        "exact_snippets": "ECOG performance status 0-2",
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                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
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                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Must be ambulant with organ function and performance status adequate for conventional combination chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "Must be ambulant",
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                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "ambulant"
                        }
                    },
                    {
                        "exact_snippets": "organ function ... adequate for conventional combination chemotherapy",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate for conventional combination chemotherapy"
                        }
                    },
                    {
                        "exact_snippets": "performance status adequate for conventional combination chemotherapy",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate for conventional combination chemotherapy"
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "Must be ambulant",
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                            "requirement_type": "status",
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                        }
                    },
                    {
                        "exact_snippets": "organ function ... adequate for conventional combination chemotherapy",
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                            "expected_value": "adequate for conventional combination chemotherapy"
                        }
                    },
                    {
                        "exact_snippets": "performance status adequate for conventional combination chemotherapy",
                        "criterion": "performance status",
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                            "requirement_type": "adequacy",
                            "expected_value": "adequate for conventional combination chemotherapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No serious hypersensitivity to letrozole or other components of study drug",
                "criterions": [
                    {
                        "exact_snippets": "No serious hypersensitivity to letrozole",
                        "criterion": "hypersensitivity to letrozole",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "not serious"
                        }
                    },
                    {
                        "exact_snippets": "No serious hypersensitivity to ... other components of study drug",
                        "criterion": "hypersensitivity to other components of study drug",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "not serious"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No serious hypersensitivity to letrozole",
                        "criterion": "hypersensitivity to letrozole",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "not serious"
                        }
                    },
                    {
                        "exact_snippets": "No serious hypersensitivity to ... other components of study drug",
                        "criterion": "hypersensitivity to other components of study drug",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "not serious"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY:",
                "criterions": [
                    {
                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
                        "criterion": "prior concurrent therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
                        "criterion": "prior concurrent therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No prior systemic treatment for recurrent or metastatic breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "No prior systemic treatment for recurrent or metastatic breast cancer",
                        "criterion": "prior systemic treatment for recurrent or metastatic breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No prior systemic treatment for recurrent or metastatic breast cancer",
                        "criterion": "prior systemic treatment for recurrent or metastatic breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No other concurrent radiotherapy, endocrine therapy, cytotoxic therapy, or experimental therapy for cancer",
                "criterions": [
                    {
                        "exact_snippets": "No other concurrent radiotherapy",
                        "criterion": "concurrent radiotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No other concurrent ... endocrine therapy",
                        "criterion": "concurrent endocrine therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No other concurrent ... cytotoxic therapy",
                        "criterion": "concurrent cytotoxic therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No other concurrent ... experimental therapy for cancer",
                        "criterion": "concurrent experimental therapy for cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "No other concurrent radiotherapy",
                                                "criterion": "concurrent radiotherapy",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            },
                                            {
                                                "exact_snippets": "No other concurrent ... endocrine therapy",
                                                "criterion": "concurrent endocrine therapy",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "No other concurrent ... cytotoxic therapy",
                                        "criterion": "concurrent cytotoxic therapy",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "No other concurrent ... experimental therapy for cancer",
                                "criterion": "concurrent experimental therapy for cancer",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "PATIENT CHARACTERISTICS:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "* Measurable or evaluable disease not in a previously irradiated area",
                "criterions": [
                    {
                        "exact_snippets": "Measurable or evaluable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "not in a previously irradiated area",
                        "criterion": "disease location",
                        "requirement": {
                            "requirement_type": "previous irradiation",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Measurable or evaluable disease",
                                "criterion": "disease",
                                "requirement": {
                                    "requirement_type": "measurability",
                                    "expected_value": [
                                        "measurable",
                                        "evaluable"
                                    ]
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "not in a previously irradiated area",
                                    "criterion": "disease location",
                                    "requirement": {
                                        "requirement_type": "previous irradiation",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* HER2-positive by fluorescent in situ hybridization or chromogenic in situ hybridization",
                "criterions": [
                    {
                        "exact_snippets": "HER2-positive by fluorescent in situ hybridization or chromogenic in situ hybridization",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "HER2-positive by fluorescent in situ hybridization or chromogenic in situ hybridization",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "fluorescent in situ hybridization",
                                "chromogenic in situ hybridization"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "HER2-positive by fluorescent in situ hybridization or chromogenic in situ hybridization",
                                "criterion": "HER2 status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "positive"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "HER2-positive by fluorescent in situ hybridization or chromogenic in situ hybridization",
                                        "criterion": "HER2 status",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "fluorescent in situ hybridization"
                                        }
                                    },
                                    {
                                        "exact_snippets": "HER2-positive by fluorescent in situ hybridization or chromogenic in situ hybridization",
                                        "criterion": "HER2 status",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "chromogenic in situ hybridization"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No other prior or concurrent malignancy except for basal cell carcinoma or carcinoma in situ of the cervix",
                "criterions": [
                    {
                        "exact_snippets": "No other prior or concurrent malignancy",
                        "criterion": "prior or concurrent malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "except for basal cell carcinoma",
                        "criterion": "basal cell carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except for ... carcinoma in situ of the cervix",
                        "criterion": "carcinoma in situ of the cervix",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "No other prior or concurrent malignancy",
                                    "criterion": "prior or concurrent malignancy",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "except for basal cell carcinoma",
                                        "criterion": "basal cell carcinoma",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "except for ... carcinoma in situ of the cervix",
                                        "criterion": "carcinoma in situ of the cervix",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        }
    ]
}