{
    "info": {
        "nct_id": "NCT01094548",
        "official_title": "A Randomized, Open-label, Phase II Study With Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Subjects With Either Chemotherapy-naïve, Slowly Progressive, Asymptomatic Multiple Myeloma or With Stage II/III Multiple Myeloma in Stable Response/Plateau Phase Following Anti-tumor Therapy",
        "inclusion_criteria": "* Documented previously untreated, Mucinous glycoprotein 1 (MUC1)-expressing, slowly progressive asymptomatic multiple myeloma with an increasing M-protein concentration displayed on two occasions separated by an interval of at least 4 weeks within the last 18 months, or\n* Documented MUC1-expressing stage II or III multiple myeloma with a treatment-free interval of at least 3 months following prior anti-tumor therapy, and fulfilling criteria for having a stable response/plateau phase\n* Signed written informed consent\n* MUC1-expressing myeloma cells in the bone marrow\n* Greater than or equal to (>=) 18 years of age\n* Life expectancy of at least 6 months\n* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 1 at study entry\n* Effective contraception for both male and female subjects, if the possibility of conception exists\n* A platelet count >=100 x 10^9/Liter, white blood cells >=2.5 x 10^9/Liter, and hemoglobin >=90 gram per liter (g/L)\n* Total bilirubin <= 1.5 x upper reference range\n* Aspartate aminotransferase (AST) <= 2.5 x upper reference range\n* Serum creatinine <= 2 x upper reference\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Pre-Therapies:\n\n* Previous exposure to MUC1 targeting therapy\n* Radiotherapy or any investigational drug in the 30 days before the start of treatment in this study\n* Receipt of immunotherapy (Example: interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within 4 weeks (28 days) prior to randomization\n* Any preexisting medical condition requiring chronic oral or intravenous steroid or immunosuppressive therapy except for maintenance doses of prednisone of <=10 milligram per day (mg/day)\n\nMedical Conditions:\n\n* Autoimmune disease that in the opinion of the investigator could compromise the safety of the subject in this study\n* Hereditary or congenital immunodeficiencies\n* Known hypersensitivity reaction to any of the components of study treatments\n* Clinically significant cardiac disease, Example: New York Heart Association (NYHA) classes III-IV; unstable angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months\n* Other previous malignancies within 5 years, with exception of a history of a previous basal cell carcinoma of the skin, carcinoma in situ of uterine cervix, gastrointestinal intramucosal carcinoma\n* Known Hepatitis B and/or C\n* Splenectomy\n\nStandard Safety:\n\n* Known alcohol or drug abuse\n* Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent\n* Significant disease which, in the investigator's opinion, would exclude the subject from the study\n* Pregnant or breast-feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator. Subjects whom the investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard\n* Participation in another clinical study within the past 30 days\n* Legal incapacity or limited legal capacity\n* Concurrent treatment with a non-permitted drug\n* Any other reason that, in the opinion of the investigator, precludes the subject from participating in the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Documented previously untreated, Mucinous glycoprotein 1 (MUC1)-expressing, slowly progressive asymptomatic multiple myeloma with an increasing M-protein concentration displayed on two occasions separated by an interval of at least 4 weeks within the last 18 months, or",
            "criterions": [
                {
                    "exact_snippets": "Documented previously untreated",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Mucinous glycoprotein 1 (MUC1)-expressing",
                    "criterion": "MUC1 expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "slowly progressive asymptomatic multiple myeloma",
                    "criterion": "multiple myeloma",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "slowly progressive"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "increasing M-protein concentration displayed on two occasions separated by an interval of at least 4 weeks within the last 18 months",
                    "criterion": "M-protein concentration",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "increasing"
                        },
                        {
                            "requirement_type": "measurement frequency",
                            "expected_value": "two occasions separated by an interval of at least 4 weeks within the last 18 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented MUC1-expressing stage II or III multiple myeloma with a treatment-free interval of at least 3 months following prior anti-tumor therapy, and fulfilling criteria for having a stable response/plateau phase",
            "criterions": [
                {
                    "exact_snippets": "Documented MUC1-expressing",
                    "criterion": "MUC1 expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stage II or III multiple myeloma",
                    "criterion": "multiple myeloma stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "III"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment-free interval of at least 3 months following prior anti-tumor therapy",
                    "criterion": "treatment-free interval",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "fulfilling criteria for having a stable response/plateau phase",
                    "criterion": "response phase",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable response/plateau phase"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signed written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "format",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* MUC1-expressing myeloma cells in the bone marrow",
            "criterions": [
                {
                    "exact_snippets": "MUC1-expressing myeloma cells",
                    "criterion": "MUC1 expression in myeloma cells",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myeloma cells in the bone marrow",
                    "criterion": "myeloma cells in the bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Greater than or equal to (>=) 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Greater than or equal to (>=) 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 6 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 1 at study entry",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Effective contraception for both male and female subjects, if the possibility of conception exists",
            "criterions": [
                {
                    "exact_snippets": "Effective contraception for both male and female subjects",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if the possibility of conception exists",
                    "criterion": "possibility of conception",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A platelet count >=100 x 10^9/Liter, white blood cells >=2.5 x 10^9/Liter, and hemoglobin >=90 gram per liter (g/L)",
            "criterions": [
                {
                    "exact_snippets": "platelet count >=100 x 10^9/Liter",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/Liter"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "white blood cells >=2.5 x 10^9/Liter",
                    "criterion": "white blood cells",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "x 10^9/Liter"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin >=90 gram per liter (g/L)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "gram per liter (g/L)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin <= 1.5 x upper reference range",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin <= 1.5 x upper reference range",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x upper reference range"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST) <= 2.5 x upper reference range",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) <= 2.5 x upper reference range",
                    "criterion": "Aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x upper reference range"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine <= 2 x upper reference",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine <= 2 x upper reference",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x upper reference"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "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": "Pre-Therapies:",
            "criterions": [
                {
                    "exact_snippets": "Pre-Therapies",
                    "criterion": "pre-therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous exposure to MUC1 targeting therapy",
            "criterions": [
                {
                    "exact_snippets": "Previous exposure to MUC1 targeting therapy",
                    "criterion": "MUC1 targeting therapy",
                    "requirements": [
                        {
                            "requirement_type": "exposure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiotherapy or any investigational drug in the 30 days before the start of treatment in this study",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy ... in the 30 days before the start of treatment",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any investigational drug in the 30 days before the start of treatment",
                    "criterion": "investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receipt of immunotherapy (Example: interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within 4 weeks (28 days) prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "Receipt of immunotherapy ... within 4 weeks (28 days) prior to randomization",
                    "criterion": "receipt of immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any preexisting medical condition requiring chronic oral or intravenous steroid or immunosuppressive therapy except for maintenance doses of prednisone of <=10 milligram per day (mg/day)",
            "criterions": [
                {
                    "exact_snippets": "preexisting medical condition requiring chronic oral or intravenous steroid or immunosuppressive therapy",
                    "criterion": "preexisting medical condition requiring chronic steroid or immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "maintenance doses of prednisone of <=10 milligram per day (mg/day)",
                    "criterion": "maintenance dose of prednisone",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg/day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Medical Conditions:",
            "criterions": [
                {
                    "exact_snippets": "Medical Conditions",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Autoimmune disease that in the opinion of the investigator could compromise the safety of the subject in this study",
            "criterions": [
                {
                    "exact_snippets": "Autoimmune disease ... could compromise the safety of the subject",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "safety risk",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hereditary or congenital immunodeficiencies",
            "criterions": [
                {
                    "exact_snippets": "Hereditary or congenital immunodeficiencies",
                    "criterion": "immunodeficiencies",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "hereditary",
                                "congenital"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity reaction to any of the components of study treatments",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity reaction to any of the components of study treatments",
                    "criterion": "hypersensitivity reaction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant cardiac disease, Example: New York Heart Association (NYHA) classes III-IV; unstable angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association (NYHA) classes III-IV",
                    "criterion": "NYHA class",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction in the previous 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other previous malignancies within 5 years, with exception of a history of a previous basal cell carcinoma of the skin, carcinoma in situ of uterine cervix, gastrointestinal intramucosal carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Other previous malignancies within 5 years",
                    "criterion": "previous malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of a history of a previous basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of a history of a ... carcinoma in situ of uterine cervix",
                    "criterion": "carcinoma in situ of uterine cervix",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of a history of a ... gastrointestinal intramucosal carcinoma",
                    "criterion": "gastrointestinal intramucosal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known Hepatitis B and/or C",
            "criterions": [
                {
                    "exact_snippets": "Known Hepatitis B",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known ... C",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Splenectomy",
            "criterions": [
                {
                    "exact_snippets": "Splenectomy",
                    "criterion": "splenectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Standard Safety:",
            "criterions": [
                {
                    "exact_snippets": "Standard Safety",
                    "criterion": "safety",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known alcohol or drug abuse",
            "criterions": [
                {
                    "exact_snippets": "Known alcohol or drug abuse",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known alcohol or drug abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent",
            "criterions": [
                {
                    "exact_snippets": "Medical ... conditions that would not permit the subject to complete the study or sign informed consent",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on study participation",
                            "expected_value": "would not permit completion or signing consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "psychological conditions that would not permit the subject to complete the study or sign informed consent",
                    "criterion": "psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on study participation",
                            "expected_value": "would not permit completion or signing consent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant disease which, in the investigator's opinion, would exclude the subject from the study",
            "criterions": [
                {
                    "exact_snippets": "Significant disease ... would exclude the subject from the study",
                    "criterion": "significant disease",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breast-feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator. Subjects whom the investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard",
            "criterions": [
                {
                    "exact_snippets": "Pregnant or breast-feeding women",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not pregnant or breast-feeding"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential, unless using effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects whom the investigator considers may be at risk of pregnancy will have a pregnancy test performed",
                    "criterion": "risk of pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "as determined by the investigator"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation in another clinical study within the past 30 days",
            "criterions": [
                {
                    "exact_snippets": "Participation in another clinical study within the past 30 days",
                    "criterion": "participation in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Legal incapacity or limited legal capacity",
            "criterions": [
                {
                    "exact_snippets": "Legal incapacity",
                    "criterion": "legal capacity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "incapacity"
                        }
                    ]
                },
                {
                    "exact_snippets": "limited legal capacity",
                    "criterion": "legal capacity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "limited"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent treatment with a non-permitted drug",
            "criterions": [
                {
                    "exact_snippets": "Concurrent treatment with a non-permitted drug",
                    "criterion": "concurrent treatment",
                    "requirements": [
                        {
                            "requirement_type": "drug type",
                            "expected_value": "non-permitted"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other reason that, in the opinion of the investigator, precludes the subject from participating in the study",
            "criterions": [
                {
                    "exact_snippets": "Any other reason that, in the opinion of the investigator, precludes the subject from participating in the study",
                    "criterion": "investigator's opinion",
                    "requirements": [
                        {
                            "requirement_type": "preclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}