{
    "info": {
        "nct_id": "NCT00626431",
        "official_title": "A Phase 3, Multi-Center, Open-Label, Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Two 6-Month Leuprolide Formulations, in Subjects With Prostatic Adenocarcinoma",
        "inclusion_criteria": "* Voluntarily sign an IRB-approved informed consent form and any required privacy statement/authorization form.\n* Pre-trial serum testosterone level >150 ng/dL.\n* Histologically-confirmed prostatic adenocarcinoma in Jewett Clinical Stage A2, B, C or D and TNM* classification cT1b-4, N: any, M: any.\n\n  *Tumor/Nodes/Metastases\n* Subjects with a rising PSA following radical prostatectomy defined as an increase of 0.2 ng/mL from the previous test on two consecutive testings or rising PSA following prostate irradiation using Phoenix Definition of a rise of greater than or equal to 2.0 ng/mL above the nadir.\n* Prostate cancer and general clinical status is sufficient to warrant at least 48 weeks of continuous androgen deprivation treatment, without concomitant antiandrogen treatment.\n* Eastern Cooperative Oncology Group (ECOG) Performance status grades 0,1,or 2 at the time of pre-trial screening.\n* Life expectancy of at least 18 months.\n* Subjects with serum creatinine ≤1.9 mg/dL, bilirubin ≤2.0 mg/dL (unless Gilbert's syndrome with normal AST, ALT); AST and ALT ≤2.5 times the upper limit of normal.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Requires additional treatment including radical prostatectomy, radiotherapy or cryotherapy of local disease.\n* Historical, clinical, or radiographic evidence of central nervous system metastases, including spinal cord metastasis.\n* Clinical evidence of urinary tract obstruction.\n* History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.\n* History of clinical hypogonadism.\n* Current malignancy or history of malignancy except for prostate cancer or basal or squamous cell carcinoma of the skin.\n* Clinical or laboratory evidence of any severe underlying disease state (excluding prostate cancer) that would place subjects in additional jeopardy by participating in this trial.\n* Hypersensitivity to leuprolide, polylactic acid, or any excipient of the drug.\n* Incomplete recovery from the effects of any major surgery.\n* History of receiving of the following prostate cancer therapies within 8 weeks prior to the Screening Visit: chemotherapy, immunotherapy, antiandrogen, radiation therapy, cryotherapy, strontium, or biological response modifiers.\n* History of prostatic surgery within 4 weeks prior to the Screening Visit.\n* Received hormonal therapy, including GnRH analogs (less than or equal to 6 month depot administration), estrogen, Megace and phytotherapy, within 32 weeks prior to the Screening Visit and during the trial.\n* Alternative medical therapies which have an estrogenic, androgenic, or antiandrogenic effect (including phyto-estrogens and phyto-androgens) within 12 weeks prior to the Screening Visit and during the trial.\n* Requires the chronic use of systemic corticosteroids and anticonvulsants that may affect bone loss such as carbamazepine, phenobarbital, phenytoin, valproic acid or primidone.\n* May require antiandrogen, immuno-, or surgical therapy for prostate cancer during the trial.\n* History of alcoholism or consumes >14 alcoholic beverages per week or illicit drug abuse within 12 months prior to screening.\n* Received therapy with a GnRH analog (1 year implant) within 60 weeks prior to the Screening Visit.\n* Received therapy with finasteride or ketoconazole within 1 week prior to the Screening Visit; dutasteride within 25 weeks prior to the Screening Visit.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Voluntarily sign an IRB-approved informed consent form and any required privacy statement/authorization form.",
            "criterions": [
                {
                    "exact_snippets": "Voluntarily sign an IRB-approved informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any required privacy statement/authorization form",
                    "criterion": "privacy statement/authorization form",
                    "requirements": [
                        {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-trial serum testosterone level >150 ng/dL.",
            "criterions": [
                {
                    "exact_snippets": "serum testosterone level >150 ng/dL",
                    "criterion": "serum testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "ng/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "*Tumor/Nodes/Metastases",
            "criterions": [
                {
                    "exact_snippets": "Tumor",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Nodes",
                    "criterion": "nodes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Metastases",
                    "criterion": "metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with a rising PSA following radical prostatectomy defined as an increase of 0.2 ng/mL from the previous test on two consecutive testings or rising PSA following prostate irradiation using Phoenix Definition of a rise of greater than or equal to 2.0 ng/mL above the nadir.",
            "criterions": [
                {
                    "exact_snippets": "rising PSA following radical prostatectomy defined as an increase of 0.2 ng/mL from the previous test on two consecutive testings",
                    "criterion": "rising PSA following radical prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "increase",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.2,
                                "unit": "ng/mL"
                            }
                        },
                        {
                            "requirement_type": "consecutive tests",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rising PSA following prostate irradiation using Phoenix Definition of a rise of greater than or equal to 2.0 ng/mL above the nadir",
                    "criterion": "rising PSA following prostate irradiation",
                    "requirements": [
                        {
                            "requirement_type": "increase",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.0,
                                "unit": "ng/mL"
                            }
                        },
                        {
                            "requirement_type": "Phoenix Definition",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prostate cancer and general clinical status is sufficient to warrant at least 48 weeks of continuous androgen deprivation treatment, without concomitant antiandrogen treatment.",
            "criterions": [
                {
                    "exact_snippets": "Prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "general clinical status is sufficient to warrant at least 48 weeks of continuous androgen deprivation treatment",
                    "criterion": "general clinical status",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency for treatment",
                            "expected_value": "at least 48 weeks of continuous androgen deprivation treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "without concomitant antiandrogen treatment",
                    "criterion": "antiandrogen treatment",
                    "requirements": [
                        {
                            "requirement_type": "concomitant treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance status grades 0,1,or 2 at the time of pre-trial screening.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance status grades 0,1,or 2",
                    "criterion": "ECOG Performance status",
                    "requirements": [
                        {
                            "requirement_type": "grades",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 18 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 18 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with serum creatinine ≤1.9 mg/dL, bilirubin ≤2.0 mg/dL (unless Gilbert's syndrome with normal AST, ALT); AST and ALT ≤2.5 times the upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": "serum creatinine ≤1.9 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.9,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "bilirubin ≤2.0 mg/dL (unless Gilbert's syndrome with normal AST, ALT)",
                    "criterion": "bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "bilirubin ≤2.0 mg/dL (unless Gilbert's syndrome with normal AST, ALT)",
                    "criterion": "Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "normal AST, ALT"
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT ≤2.5 times the upper limit of normal",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT ≤2.5 times the upper limit of normal",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Requires additional treatment including radical prostatectomy, radiotherapy or cryotherapy of local disease.",
            "criterions": [
                {
                    "exact_snippets": "Requires additional treatment including radical prostatectomy",
                    "criterion": "additional treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "radical prostatectomy",
                                "radiotherapy",
                                "cryotherapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Historical, clinical, or radiographic evidence of central nervous system metastases, including spinal cord metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Historical, clinical, or radiographic evidence of central nervous system metastases",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "historical",
                                "clinical",
                                "radiographic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal cord metastasis",
                    "criterion": "spinal cord metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical evidence of urinary tract obstruction.",
            "criterions": [
                {
                    "exact_snippets": "Clinical evidence of urinary tract obstruction.",
                    "criterion": "urinary tract obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.",
            "criterions": [
                {
                    "exact_snippets": "History of bilateral orchiectomy",
                    "criterion": "bilateral orchiectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... adrenalectomy",
                    "criterion": "adrenalectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... hypophysectomy",
                    "criterion": "hypophysectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of clinical hypogonadism.",
            "criterions": [
                {
                    "exact_snippets": "History of clinical hypogonadism",
                    "criterion": "clinical hypogonadism",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current malignancy or history of malignancy except for prostate cancer or basal or squamous cell carcinoma of the skin.",
            "criterions": [
                {
                    "exact_snippets": "Current malignancy",
                    "criterion": "current malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of malignancy",
                    "criterion": "history of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... basal or squamous cell carcinoma of the skin",
                    "criterion": "basal or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical or laboratory evidence of any severe underlying disease state (excluding prostate cancer) that would place subjects in additional jeopardy by participating in this trial.",
            "criterions": [
                {
                    "exact_snippets": "Clinical or laboratory evidence of any severe underlying disease state (excluding prostate cancer)",
                    "criterion": "severe underlying disease state",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypersensitivity to leuprolide, polylactic acid, or any excipient of the drug.",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to leuprolide",
                    "criterion": "hypersensitivity to leuprolide",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... polylactic acid",
                    "criterion": "hypersensitivity to polylactic acid",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... any excipient of the drug",
                    "criterion": "hypersensitivity to any excipient of the drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Incomplete recovery from the effects of any major surgery.",
            "criterions": [
                {
                    "exact_snippets": "Incomplete recovery from the effects of any major surgery.",
                    "criterion": "recovery from major surgery",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of receiving of the following prostate cancer therapies within 8 weeks prior to the Screening Visit: chemotherapy, immunotherapy, antiandrogen, radiation therapy, cryotherapy, strontium, or biological response modifiers.",
            "criterions": [
                {
                    "exact_snippets": "History of receiving of the following prostate cancer therapies within 8 weeks prior to the Screening Visit: chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history of receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of receiving of the following prostate cancer therapies within 8 weeks prior to the Screening Visit: ... immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history of receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of receiving of the following prostate cancer therapies within 8 weeks prior to the Screening Visit: ... antiandrogen",
                    "criterion": "antiandrogen therapy",
                    "requirements": [
                        {
                            "requirement_type": "history of receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of receiving of the following prostate cancer therapies within 8 weeks prior to the Screening Visit: ... radiation therapy",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "history of receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of receiving of the following prostate cancer therapies within 8 weeks prior to the Screening Visit: ... cryotherapy",
                    "criterion": "cryotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history of receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of receiving of the following prostate cancer therapies within 8 weeks prior to the Screening Visit: ... strontium",
                    "criterion": "strontium therapy",
                    "requirements": [
                        {
                            "requirement_type": "history of receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of receiving of the following prostate cancer therapies within 8 weeks prior to the Screening Visit: ... biological response modifiers",
                    "criterion": "biological response modifiers",
                    "requirements": [
                        {
                            "requirement_type": "history of receiving",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of prostatic surgery within 4 weeks prior to the Screening Visit.",
            "criterions": [
                {
                    "exact_snippets": "History of prostatic surgery within 4 weeks prior to the Screening Visit.",
                    "criterion": "prostatic surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received hormonal therapy, including GnRH analogs (less than or equal to 6 month depot administration), estrogen, Megace and phytotherapy, within 32 weeks prior to the Screening Visit and during the trial.",
            "criterions": [
                {
                    "exact_snippets": "Received hormonal therapy, including GnRH analogs (less than or equal to 6 month depot administration), estrogen, Megace and phytotherapy, within 32 weeks prior to the Screening Visit",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "GnRH analogs",
                                "estrogen",
                                "Megace",
                                "phytotherapy"
                            ]
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 32,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alternative medical therapies which have an estrogenic, androgenic, or antiandrogenic effect (including phyto-estrogens and phyto-androgens) within 12 weeks prior to the Screening Visit and during the trial.",
            "criterions": [
                {
                    "exact_snippets": "Alternative medical therapies which have an estrogenic, androgenic, or antiandrogenic effect",
                    "criterion": "alternative medical therapies",
                    "requirements": [
                        {
                            "requirement_type": "effect",
                            "expected_value": [
                                "estrogenic",
                                "androgenic",
                                "antiandrogenic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "within 12 weeks prior to the Screening Visit",
                    "criterion": "use of alternative medical therapies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 12 weeks prior to the Screening Visit"
                        }
                    ]
                },
                {
                    "exact_snippets": "during the trial",
                    "criterion": "use of alternative medical therapies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during the trial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Requires the chronic use of systemic corticosteroids and anticonvulsants that may affect bone loss such as carbamazepine, phenobarbital, phenytoin, valproic acid or primidone.",
            "criterions": [
                {
                    "exact_snippets": "chronic use of systemic corticosteroids",
                    "criterion": "chronic use of systemic corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic use of ... anticonvulsants that may affect bone loss such as carbamazepine, phenobarbital, phenytoin, valproic acid or primidone",
                    "criterion": "chronic use of anticonvulsants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "effect on bone loss",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* May require antiandrogen, immuno-, or surgical therapy for prostate cancer during the trial.",
            "criterions": [
                {
                    "exact_snippets": "antiandrogen ... therapy for prostate cancer",
                    "criterion": "antiandrogen therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "immuno- ... therapy for prostate cancer",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical therapy for prostate cancer",
                    "criterion": "surgical therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of alcoholism or consumes >14 alcoholic beverages per week or illicit drug abuse within 12 months prior to screening.",
            "criterions": [
                {
                    "exact_snippets": "History of alcoholism",
                    "criterion": "alcoholism",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "consumes >14 alcoholic beverages per week",
                    "criterion": "alcohol consumption",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 14,
                                "unit": "alcoholic beverages per week"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "illicit drug abuse within 12 months prior to screening",
                    "criterion": "illicit drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 12 months prior to screening"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received therapy with a GnRH analog (1 year implant) within 60 weeks prior to the Screening Visit.",
            "criterions": [
                {
                    "exact_snippets": "Received therapy with a GnRH analog (1 year implant)",
                    "criterion": "GnRH analog therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 60 weeks prior to the Screening Visit",
                    "criterion": "time since GnRH analog therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received therapy with finasteride or ketoconazole within 1 week prior to the Screening Visit; dutasteride within 25 weeks prior to the Screening Visit.",
            "criterions": [
                {
                    "exact_snippets": "Received therapy with finasteride ... within 1 week prior to the Screening Visit",
                    "criterion": "finasteride therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received therapy with ... ketoconazole within 1 week prior to the Screening Visit",
                    "criterion": "ketoconazole therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received therapy with ... dutasteride within 25 weeks prior to the Screening Visit",
                    "criterion": "dutasteride therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Histologically-confirmed prostatic adenocarcinoma in Jewett Clinical Stage A2, B, C or D and TNM* classification cT1b-4, N: any, M: any.",
            "criterions": [
                {
                    "exact_snippets": "Histologically-confirmed prostatic adenocarcinoma",
                    "criterion": "prostatic adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically-confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Jewett Clinical Stage A2, B, C or D",
                    "criterion": "Jewett Clinical Stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "A2",
                                "B",
                                "C",
                                "D"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "TNM classification cT1b-4",
                    "criterion": "TNM classification T",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1.5,
                                        "unit": "cT"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "cT"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "TNM classification ... N: any",
                    "criterion": "TNM classification N",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "TNM classification ... M: any",
                    "criterion": "TNM classification M",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}