{
    "info": {
        "nct_id": "NCT04060862",
        "official_title": "A Phase Ib/III Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer",
        "inclusion_criteria": "* HR+ HER2- adenocarcinoma of the breast that is locally advanced unresectable or metastatic\n* For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs\n* For men: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating sperm\n* Radiologic/objective relapse during adjuvant endocrine therapy or disease progression during the initial 12 months of 1L endocrine therapy in locally advanced unresectable or metastatic breast cancer\n* At least one measurable lesion via Response Evaluation Criteria in Solid Tumors, Version 1.1\n* Phase III only: Tumor specimen from the most recently collected, available tumor tissue\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pregnant or breastfeeding, or intending to become pregnant\n* Prior treatment with fulvestrant or other selective estrogen receptor down-regulator\n* Prior treatment with PI3K inhibitor, mTOR inhibitor or AKT inhibitor\n* Phase III only: Prior treatment with CDK4/6 inhibitor for locally advanced unresectable or metastatic breast cancer\n* Prior treatment with a cytotoxic chemotherapy regimen for metastatic breast cancer\n* History of Type I or Type II diabetes mellitus requiring insulin\n* History of or active inflammatory bowel disease or active bowel inflammation\n* Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* HR+ HER2- adenocarcinoma of the breast that is locally advanced unresectable or metastatic",
                "criterions": [
                    {
                        "exact_snippets": "HR+",
                        "criterion": "hormone receptor status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "HER2-",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "adenocarcinoma of the breast",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "adenocarcinoma of the breast"
                        }
                    },
                    {
                        "exact_snippets": "locally advanced unresectable",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced unresectable"
                        }
                    },
                    {
                        "exact_snippets": "metastatic",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "HR+",
                                "criterion": "hormone receptor status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "positive"
                                }
                            },
                            {
                                "exact_snippets": "HER2-",
                                "criterion": "HER2 status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "negative"
                                }
                            },
                            {
                                "exact_snippets": "adenocarcinoma of the breast",
                                "criterion": "cancer type",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "adenocarcinoma of the breast"
                                }
                            },
                            {
                                "exact_snippets": "locally advanced unresectable",
                                "criterion": "cancer stage",
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                                    "requirement_type": "stage",
                                    "expected_value": "locally advanced unresectable"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "HR+",
                                "criterion": "hormone receptor status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "positive"
                                }
                            },
                            {
                                "exact_snippets": "HER2-",
                                "criterion": "HER2 status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "negative"
                                }
                            },
                            {
                                "exact_snippets": "adenocarcinoma of the breast",
                                "criterion": "cancer type",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "adenocarcinoma of the breast"
                                }
                            },
                            {
                                "exact_snippets": "metastatic",
                                "criterion": "cancer stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "metastatic"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs",
                "criterions": [
                    {
                        "exact_snippets": "For women of childbearing potential",
                        "criterion": "women of childbearing potential",
                        "requirement": {
                            "requirement_type": "agreement to remain abstinent or use contraception",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "For women of childbearing potential",
                        "criterion": "women of childbearing potential",
                        "requirement": {
                            "requirement_type": "agreement to refrain from donating eggs",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "For women of childbearing potential",
                                "criterion": "women of childbearing potential",
                                "requirement": {
                                    "requirement_type": "agreement to remain abstinent or use contraception",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "For women of childbearing potential",
                                "criterion": "women of childbearing potential",
                                "requirement": {
                                    "requirement_type": "agreement to refrain from donating eggs",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Radiologic/objective relapse during adjuvant endocrine therapy or disease progression during the initial 12 months of 1L endocrine therapy in locally advanced unresectable or metastatic breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "Radiologic/objective relapse during adjuvant endocrine therapy",
                        "criterion": "relapse during adjuvant endocrine therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "disease progression during the initial 12 months of 1L endocrine therapy",
                        "criterion": "disease progression during 1L endocrine therapy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "locally advanced unresectable or metastatic breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced unresectable",
                                "metastatic"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Radiologic/objective relapse during adjuvant endocrine therapy",
                                "criterion": "relapse during adjuvant endocrine therapy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "locally advanced unresectable or metastatic breast cancer",
                                "criterion": "breast cancer",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "locally advanced unresectable",
                                        "metastatic"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "disease progression during the initial 12 months of 1L endocrine therapy",
                                "criterion": "disease progression during 1L endocrine therapy",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "locally advanced unresectable or metastatic breast cancer",
                                "criterion": "breast cancer",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "locally advanced unresectable",
                                        "metastatic"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least one measurable lesion via Response Evaluation Criteria in Solid Tumors, Version 1.1",
                "criterions": [
                    {
                        "exact_snippets": "At least one measurable lesion via Response Evaluation Criteria in Solid Tumors, Version 1.1",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "At least one measurable lesion via Response Evaluation Criteria in Solid Tumors, Version 1.1",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Phase III only: Tumor specimen from the most recently collected, available tumor tissue",
                "criterions": [
                    {
                        "exact_snippets": "Tumor specimen from the most recently collected, available tumor tissue",
                        "criterion": "tumor specimen",
                        "requirement": {
                            "requirement_type": "collection recency",
                            "expected_value": "most recently collected"
                        }
                    },
                    {
                        "exact_snippets": "Tumor specimen from the most recently collected, available tumor tissue",
                        "criterion": "tumor specimen",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Tumor specimen from the most recently collected, available tumor tissue",
                                "criterion": "tumor specimen",
                                "requirement": {
                                    "requirement_type": "collection recency",
                                    "expected_value": "most recently collected"
                                }
                            },
                            {
                                "exact_snippets": "Tumor specimen from the most recently collected, available tumor tissue",
                                "criterion": "tumor specimen",
                                "requirement": {
                                    "requirement_type": "availability",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Phase III only",
                        "criterion": "trial phase",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "III"
                        }
                    }
                ]
            }
        },
        {
            "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": {
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                    {
                        "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": "* For men: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating sperm",
                "criterions": [
                    {
                        "exact_snippets": "For men: agreement to remain abstinent or use contraceptive methods",
                        "criterion": "contraceptive agreement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "For men: agreement to refrain from donating sperm",
                        "criterion": "sperm donation",
                        "requirement": {
                            "requirement_type": "refrain",
                            "expected_value": true
                        }
                    }
                ]
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                        "or_criteria": [
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                                "exact_snippets": "For men: agreement to remain abstinent or use contraceptive methods",
                                "criterion": "contraceptive agreement",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "For men: agreement to remain abstinent or use contraceptive methods",
                                "criterion": "contraceptive agreement",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "For men: agreement to refrain from donating sperm",
                        "criterion": "sperm donation",
                        "requirement": {
                            "requirement_type": "refrain",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Pregnant or breastfeeding, or intending to become pregnant",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "intending to become pregnant",
                        "criterion": "intention to become pregnant",
                        "requirement": {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Pregnant",
                                "criterion": "pregnancy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "breastfeeding",
                                "criterion": "breastfeeding",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "intending to become pregnant",
                        "criterion": "intention to become pregnant",
                        "requirement": {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior treatment with fulvestrant or other selective estrogen receptor down-regulator",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with fulvestrant",
                        "criterion": "prior treatment with fulvestrant",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other selective estrogen receptor down-regulator",
                        "criterion": "prior treatment with selective estrogen receptor down-regulator",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Prior treatment with fulvestrant",
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                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other selective estrogen receptor down-regulator",
                        "criterion": "prior treatment with selective estrogen receptor down-regulator",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior treatment with PI3K inhibitor, mTOR inhibitor or AKT inhibitor",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with PI3K inhibitor",
                        "criterion": "PI3K inhibitor treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... mTOR inhibitor",
                        "criterion": "mTOR inhibitor treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... AKT inhibitor",
                        "criterion": "AKT inhibitor treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Prior treatment with PI3K inhibitor",
                        "criterion": "PI3K inhibitor treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... mTOR inhibitor",
                        "criterion": "mTOR inhibitor treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... AKT inhibitor",
                        "criterion": "AKT inhibitor treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Phase III only: Prior treatment with CDK4/6 inhibitor for locally advanced unresectable or metastatic breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "Phase III only: Prior treatment with CDK4/6 inhibitor for locally advanced unresectable or metastatic breast cancer",
                        "criterion": "prior treatment with CDK4/6 inhibitor",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "locally advanced unresectable or metastatic breast cancer"
                        }
                    }
                ]
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            "logical_structure": {
                "condition": {
                    "exact_snippets": "Phase III only: Prior treatment with CDK4/6 inhibitor for locally advanced unresectable or metastatic breast cancer",
                    "criterion": "prior treatment with CDK4/6 inhibitor",
                    "requirement": {
                        "requirement_type": "condition",
                        "expected_value": "locally advanced unresectable or metastatic breast cancer"
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Phase III only: Prior treatment with CDK4/6 inhibitor for locally advanced unresectable or metastatic breast cancer",
                    "criterion": "phase",
                    "requirement": {
                        "requirement_type": "condition",
                        "expected_value": "III"
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Prior treatment with a cytotoxic chemotherapy regimen for metastatic breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with a cytotoxic chemotherapy regimen",
                        "criterion": "prior cytotoxic chemotherapy treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "metastatic breast cancer",
                        "criterion": "metastatic breast cancer",
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                        }
                    }
                ]
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                        "exact_snippets": "Prior treatment with a cytotoxic chemotherapy regimen",
                        "criterion": "prior cytotoxic chemotherapy treatment",
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                        }
                    },
                    {
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                        "criterion": "metastatic breast cancer",
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                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of or active inflammatory bowel disease or active bowel inflammation",
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                    {
                        "exact_snippets": "History of or active inflammatory bowel disease",
                        "criterion": "inflammatory bowel disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "active bowel inflammation",
                        "criterion": "bowel inflammation",
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                            "expected_value": false
                        }
                    }
                ]
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                        "exact_snippets": "History of or active inflammatory bowel disease",
                        "criterion": "inflammatory bowel disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "active bowel inflammation",
                        "criterion": "bowel inflammation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections",
                "criterions": [
                    {
                        "exact_snippets": "Lung disease: pneumonitis",
                        "criterion": "lung disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "pneumonitis"
                        }
                    },
                    {
                        "exact_snippets": "Lung disease: ... interstitial lung disease",
                        "criterion": "lung disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "interstitial lung disease"
                        }
                    },
                    {
                        "exact_snippets": "Lung disease: ... idiopathic pulmonary fibrosis",
                        "criterion": "lung disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "idiopathic pulmonary fibrosis"
                        }
                    },
                    {
                        "exact_snippets": "Lung disease: ... cystic fibrosis",
                        "criterion": "lung disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "cystic fibrosis"
                        }
                    },
                    {
                        "exact_snippets": "Lung disease: ... Aspergillosis",
                        "criterion": "lung disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "Aspergillosis"
                        }
                    },
                    {
                        "exact_snippets": "Lung disease: ... active tuberculosis",
                        "criterion": "lung disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "active tuberculosis"
                        }
                    },
                    {
                        "exact_snippets": "Lung disease: ... history of opportunistic infections",
                        "criterion": "lung disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": "opportunistic infections"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Lung disease: pneumonitis",
                                "criterion": "lung disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "pneumonitis"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Lung disease: ... interstitial lung disease",
                                "criterion": "lung disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "interstitial lung disease"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Lung disease: ... idiopathic pulmonary fibrosis",
                                "criterion": "lung disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "idiopathic pulmonary fibrosis"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Lung disease: ... cystic fibrosis",
                                "criterion": "lung disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "cystic fibrosis"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Lung disease: ... Aspergillosis",
                                "criterion": "lung disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "Aspergillosis"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Lung disease: ... active tuberculosis",
                                "criterion": "lung disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": "active tuberculosis"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Lung disease: ... history of opportunistic infections",
                                "criterion": "lung disease",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": "opportunistic infections"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* History of Type I or Type II diabetes mellitus requiring insulin",
                "criterions": [
                    {
                        "exact_snippets": "History of Type I or Type II diabetes mellitus",
                        "criterion": "diabetes mellitus",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "Type I",
                                "Type II"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "History of Type I or Type II diabetes mellitus",
                        "criterion": "diabetes mellitus",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "insulin"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "History of Type I or Type II diabetes mellitus",
                                "criterion": "diabetes mellitus",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "Type I"
                                }
                            },
                            {
                                "exact_snippets": "History of Type I or Type II diabetes mellitus",
                                "criterion": "diabetes mellitus",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "Type II"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "History of Type I or Type II diabetes mellitus",
                        "criterion": "diabetes mellitus",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "insulin"
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}