{
    "info": {
        "nct_id": "NCT01780220",
        "official_title": "Safety and Efficacy of Radiotherapy Combined With a 6-month LH-RH Agonist and Abiraterone Hormone Therapy Treatment in Biochemically-relapsing Prostate Cancer Following Surgery",
        "inclusion_criteria": "1. Histologically confirmed prostate adenocarcinoma\n2. The patients should have undergone only surgery for localized prostate adenocarcinoma: pT2, pT3 or pT4 with bladder neck involvement\n3. pN0: negative lymphadenectomy at the time of prostatectomy\n4. At inclusion the patients should have no clinical signs of progressive disease and should be M0 (bone and pelvic scans).\n5. ≥ 18 years of age with life expectancy ≥ 10 years\n6. Performance Status (ECOG) ≤ 1\n7. PSA ≤ 0.1 ng/ml after prostatectomy (dosage performed within 2 months after surgery)\n8. PSA ≥ 0.2 ng/ml et ≤ 2 ng/ml at the time of inclusion\n9. Elevation of PSA over three consecutive assays performed in the same laboratory, with a minimal interval of two months between assays, (PSA nadir level followed by two other progressive assays)\n10. At least 6 months between surgery and biochemical relapse\n11. Serum potassium ≥ 3.5 mmol/L in the 72 hours before first dose of abiraterone acetate\n12. Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min\n13. Liver function:\n\n    Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert's disease) AST and ALT < 2.5 x ULN\n14. Patients must be affiliated to a Social Security System.\n15. Patient information and written informed consent form signed for both principal and additional research\n16. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. pN1: histologically-proven lymph node involvement at initial lymphadenectomy\n2. Histology other than adenocarcinoma\n3. Previous hormone therapy including prior therapy with ketoconazole or other CYP17 inhibitor(s) for prostate cancer.\n4. Patients being treated within the last 14 days prior to inclusion with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4 (Clarithromycin, Ketoconazole, Itraconazole, Voriconazole, Ritanovir, see appendix 11) or requiring those treatments during the study\n5. Active or symptomatic viral hepatitis or chronic liver disease\n6. Surgical or chemical castration\n7. History of cancer, with the exception of basal cell carcinoma or any other cancer treated in the 5 years before inclusion and in complete remission.\n8. Previous pelvic radiotherapy\n9. Uncontrolled hypertension (defined as systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy (see appendix 10 for mandatory BP measurement guidelines)\n10. Severe and moderate hepatic impairment (Child-Pugh class B and C)\n11. Patients with severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to:\n\n    Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline\n12. Known hypersensitivity to any of the study drugs or excipients.\n13. Galactosemia, Glucose-galactose malabsorption or lactase deficiency\n14. Patients with any psychological, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n15. Individual deprived of liberty or placed under the authority of a tutor.\n16. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically confirmed prostate adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed prostate adenocarcinoma",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. The patients should have undergone only surgery for localized prostate adenocarcinoma: pT2, pT3 or pT4 with bladder neck involvement",
            "criterions": [
                {
                    "exact_snippets": "undergone only surgery for localized prostate adenocarcinoma",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "surgery"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "localized prostate adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "pT2, pT3 or pT4",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "pT2",
                                "pT3",
                                "pT4"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "bladder neck involvement",
                    "criterion": "tumor involvement",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "bladder neck"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. pN0: negative lymphadenectomy at the time of prostatectomy",
            "criterions": [
                {
                    "exact_snippets": "pN0: negative lymphadenectomy",
                    "criterion": "lymphadenectomy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. At inclusion the patients should have no clinical signs of progressive disease and should be M0 (bone and pelvic scans).",
            "criterions": [
                {
                    "exact_snippets": "no clinical signs of progressive disease",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "should be M0 (bone and pelvic scans)",
                    "criterion": "M0 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "M0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. ≥ 18 years of age with life expectancy ≥ 10 years",
            "criterions": [
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy ≥ 10 years",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Performance Status (ECOG) ≤ 1",
            "criterions": [
                {
                    "exact_snippets": "Performance Status (ECOG) ≤ 1",
                    "criterion": "Performance Status (ECOG)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. PSA ≤ 0.1 ng/ml after prostatectomy (dosage performed within 2 months after surgery)",
            "criterions": [
                {
                    "exact_snippets": "PSA ≤ 0.1 ng/ml after prostatectomy",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 0.1,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "dosage performed within 2 months after surgery",
                    "criterion": "PSA test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 2 months after surgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. PSA ≥ 0.2 ng/ml et ≤ 2 ng/ml at the time of inclusion",
            "criterions": [
                {
                    "exact_snippets": "PSA ≥ 0.2 ng/ml et ≤ 2 ng/ml",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0.2,
                                        "unit": "ng/ml"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "ng/ml"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Elevation of PSA over three consecutive assays performed in the same laboratory, with a minimal interval of two months between assays, (PSA nadir level followed by two other progressive assays)",
            "criterions": [
                {
                    "exact_snippets": "Elevation of PSA over three consecutive assays",
                    "criterion": "PSA elevation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "performed in the same laboratory",
                    "criterion": "assay location",
                    "requirements": [
                        {
                            "requirement_type": "consistency",
                            "expected_value": "same laboratory"
                        }
                    ]
                },
                {
                    "exact_snippets": "with a minimal interval of two months between assays",
                    "criterion": "interval between assays",
                    "requirements": [
                        {
                            "requirement_type": "time interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA nadir level followed by two other progressive assays",
                    "criterion": "PSA progression",
                    "requirements": [
                        {
                            "requirement_type": "sequence",
                            "expected_value": [
                                "nadir level",
                                "progressive assays"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. At least 6 months between surgery and biochemical relapse",
            "criterions": [
                {
                    "exact_snippets": "At least 6 months between surgery and biochemical relapse",
                    "criterion": "time between surgery and biochemical relapse",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Serum potassium ≥ 3.5 mmol/L in the 72 hours before first dose of abiraterone acetate",
            "criterions": [
                {
                    "exact_snippets": "Serum potassium ≥ 3.5 mmol/L",
                    "criterion": "serum potassium",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.5,
                                "unit": "mmol/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "in the 72 hours before first dose of abiraterone acetate",
                    "criterion": "time before first dose of abiraterone acetate",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "72 hours"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine < 1.5 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated creatinine clearance ≥ 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Liver function:",
            "criterions": [
                {
                    "exact_snippets": "Liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert's disease) AST and ALT < 2.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert's disease)",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT < 2.5 x ULN",
                    "criterion": "AST and ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Patients must be affiliated to a Social Security System.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be affiliated to a Social Security System.",
                    "criterion": "Social Security System affiliation",
                    "requirements": [
                        {
                            "requirement_type": "affiliation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patient information and written informed consent form signed for both principal and additional research",
            "criterions": [
                {
                    "exact_snippets": "Patient information and written informed consent form signed",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "both principal and additional research",
                    "criterion": "research type",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "principal",
                                "additional"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures",
            "criterions": [
                {
                    "exact_snippets": "willing and able to comply with scheduled visits",
                    "criterion": "compliance with scheduled visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing and able to comply with ... treatment plan",
                    "criterion": "compliance with treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing and able to comply with ... laboratory tests",
                    "criterion": "compliance with laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing and able to comply with ... other study procedures",
                    "criterion": "compliance with other study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. pN1: histologically-proven lymph node involvement at initial lymphadenectomy",
            "criterions": [
                {
                    "exact_snippets": "pN1: histologically-proven lymph node involvement",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": "histologically-proven"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histology other than adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histology other than adenocarcinoma",
                    "criterion": "histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than adenocarcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Previous hormone therapy including prior therapy with ketoconazole or other CYP17 inhibitor(s) for prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "Previous hormone therapy",
                    "criterion": "hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior therapy with ketoconazole or other CYP17 inhibitor(s)",
                    "criterion": "therapy with ketoconazole or other CYP17 inhibitor(s)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": "prostate cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients being treated within the last 14 days prior to inclusion with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4 (Clarithromycin, Ketoconazole, Itraconazole, Voriconazole, Ritanovir, see appendix 11) or requiring those treatments during the study",
            "criterions": [
                {
                    "exact_snippets": "Patients being treated within the last 14 days prior to inclusion with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4",
                    "criterion": "treatment with strong inhibitors or inducers of CYP3A4",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last 14 days prior to inclusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring those treatments during the study",
                    "criterion": "requirement for treatment with strong inhibitors or inducers of CYP3A4",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Active or symptomatic viral hepatitis or chronic liver disease",
            "criterions": [
                {
                    "exact_snippets": "Active or symptomatic viral hepatitis",
                    "criterion": "viral hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic liver disease",
                    "criterion": "chronic liver disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Surgical or chemical castration",
            "criterions": [
                {
                    "exact_snippets": "Surgical or chemical castration",
                    "criterion": "castration",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "surgical",
                                "chemical"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of cancer, with the exception of basal cell carcinoma or any other cancer treated in the 5 years before inclusion and in complete remission.",
            "criterions": [
                {
                    "exact_snippets": "History of cancer",
                    "criterion": "history of cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of basal cell carcinoma",
                    "criterion": "basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any other cancer treated in the 5 years before inclusion and in complete remission",
                    "criterion": "other cancer treated in the 5 years before inclusion and in complete remission",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Previous pelvic radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Previous pelvic radiotherapy",
                    "criterion": "pelvic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Uncontrolled hypertension (defined as systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy (see appendix 10 for mandatory BP measurement guidelines)",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension (defined as systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg)",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "systolic blood pressure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        },
                        {
                            "requirement_type": "diastolic blood pressure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy",
                    "criterion": "history of hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Severe and moderate hepatic impairment (Child-Pugh class B and C)",
            "criterions": [
                {
                    "exact_snippets": "Severe and moderate hepatic impairment (Child-Pugh class B and C)",
                    "criterion": "hepatic impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "severe",
                                "moderate"
                            ]
                        },
                        {
                            "requirement_type": "Child-Pugh class",
                            "expected_value": [
                                "B",
                                "C"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients with severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to:",
            "criterions": [
                {
                    "exact_snippets": "severe and/or uncontrolled medical disease",
                    "criterion": "medical disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant heart disease as evidenced by myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant heart disease as evidenced by ... arterial thrombotic events in the past 6 months",
                    "criterion": "arterial thrombotic events",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant heart disease as evidenced by ... severe or unstable angina",
                    "criterion": "severe or unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant heart disease as evidenced by ... New York Heart Association (NYHA) Class III or IV heart disease",
                    "criterion": "New York Heart Association (NYHA) Class III or IV heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "Class III",
                                "Class IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant heart disease as evidenced by ... cardiac ejection fraction measurement of < 50 % at baseline",
                    "criterion": "cardiac ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Known hypersensitivity to any of the study drugs or excipients.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to any of the study drugs or excipients.",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Galactosemia, Glucose-galactose malabsorption or lactase deficiency",
            "criterions": [
                {
                    "exact_snippets": "Galactosemia",
                    "criterion": "Galactosemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Glucose-galactose malabsorption",
                    "criterion": "Glucose-galactose malabsorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactase deficiency",
                    "criterion": "lactase deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Patients with any psychological, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.",
            "criterions": [
                {
                    "exact_snippets": "psychological, sociological or geographical condition potentially hampering compliance",
                    "criterion": "condition potentially hampering compliance",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "psychological",
                                "sociological",
                                "geographical"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Individual deprived of liberty or placed under the authority of a tutor.",
            "criterions": [
                {
                    "exact_snippets": "Individual deprived of liberty",
                    "criterion": "liberty status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "deprived"
                        }
                    ]
                },
                {
                    "exact_snippets": "placed under the authority of a tutor",
                    "criterion": "authority status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "under authority of a tutor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days.",
            "criterions": [
                {
                    "exact_snippets": "Patients already included in another therapeutic trial",
                    "criterion": "inclusion in another therapeutic trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "having been given an experimental drug within a period of 30 days",
                    "criterion": "administration of an experimental drug",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}