{
    "info": {
        "nct_id": "NCT02065973",
        "official_title": "An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101 in Subjects With Cervical Intraepithelial Neoplasia (CIN) and High-risk Human Papillomavirus (HPV) Infection",
        "inclusion_criteria": "1. Written informed consent prior to initiation of any study-related procedures;\n2. Nonlactating female between the ages of 21 to 65 years, inclusive;\n3. Non-childbearing potential (defined as surgically sterile or at least 2 years postmenopausal) or practicing effective contraception (defined as 2 concurrent methods of contraception, 1 of which is a barrier method) and agrees to continue using effective contraception throughout the duration of the study;\n4. Not pregnant based on a negative result on a serum human chorionic gonadotropin (HCG) test at screening Visit 1 and a negative urine pregnancy test prevaccination at Visit 2 (and at subsequent vaccination visits);\n5. Pap test documenting atypical squamous cells of undetermined significance (ASCUS)/HPV+, atypical squamous cells high grade (ASC-H), low-grade squamous intraepithelial lesion (LSIL), or high-grade squamous intraepithelial lesion (HSIL) within 4 months prior to screening Visit 1;\n6. History of pathologically confirmed CIN1 by colposcopically-directed punch biopsy, within 12 weeks prior to administration of first study vaccination (CIN 2/3 subjects will not be eligible);\n7. For the diagnosis of CIN1, has a documented satisfactory colposcopy, ie, the entire lesion as well as the entire squamocolumnar junction is visualizible by colposcopy;\n8. Confirmed high-risk HPV infection by a commercially available high-risk DNA assay (eg, Hybrid Capture II [Qiagen]);\n9. Good health with adequate hematologic, renal, hepatic, and cardiac function, as determined by the Investigator, based upon medical history, physical examination, and laboratory test results at the screening visit (Visit 1):\n\n   * Bone marrow function: absolute neutrophil count ≥1,500/µL, and platelets ≥ 100,000/ µL;\n   * Renal function: creatinine ≤ 1.5 x institutional upper limit of normal (ULN);\n   * Hepatic function: total bilirubin ≤ 1.5 x ULN (Common Terminology Criteria for AEs [CTCAE] v4.0 grade 1) except patients with Gilbert's disease (up to 5.0 mg/dL). Aspartate aminotransferase (AST) and alkaline phosphatase ≤ 2.5 x ULN.\n   * Normal Cardiac function: as assessed by history and physical exam.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 21 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "1. Atypical endometrial or glandular cells or evidence of invasive cervical carcinoma on cervical biopsy;\n2. Previous history of cancer, other than adequately treated basal cell or Stage 1 squamous cell carcinoma of the skin;\n3. Current recognized immunodeficiency disease, including infection with HIV, cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies.\n4. Received immunotherapy (eg, IFNs, tumor necrosis factor, interleukins, or biological response modifiers [granulocyte-macrophage colony-stimulating factor, granulocyte colony-stimulating factor, macrophage colony-stimulating factor]) within 30 days prior to administration of the first study vaccination;\n5. Serious, concomitant disorder, including active systemic infection requiring treatment, in the opinion of the investigator;\n6. Currently receiving or has received treatment with systemic steroids in the following dosages within 30 days prior to administration of the first study vaccination.\n\n   * Chronic or long-term corticosteroids: ≥0.5 mg/kg/day of oral prednisolone or equivalent\n   * Sporadic corticosteroids: ≥1 mg/kg/day of oral prednisolone or equivalent for 2 or more short courses of > 3 days\n   * Note: Current or recent use of intra-articular, topical or inhaled glucocorticoid therapy is acceptable;\n7. Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results;\n8. Participation in another investigational study concurrently or use of another investigational drug within 6 months prior to administration of the first study vaccination;\n9. Previously enrolled in this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Written informed consent prior to initiation of any study-related procedures;",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Nonlactating female between the ages of 21 to 65 years, inclusive;",
            "criterions": [
                {
                    "exact_snippets": "Nonlactating female",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "nonlactating"
                        }
                    ]
                },
                {
                    "exact_snippets": "female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "between the ages of 21 to 65 years, inclusive",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 21,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Non-childbearing potential (defined as surgically sterile or at least 2 years postmenopausal) or practicing effective contraception (defined as 2 concurrent methods of contraception, 1 of which is a barrier method) and agrees to continue using effective contraception throughout the duration of the study;",
            "criterions": [
                {
                    "exact_snippets": "Non-childbearing potential (defined as surgically sterile or at least 2 years postmenopausal)",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non-childbearing"
                        },
                        {
                            "requirement_type": "definition",
                            "expected_value": [
                                "surgically sterile",
                                "at least 2 years postmenopausal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "practicing effective contraception (defined as 2 concurrent methods of contraception, 1 of which is a barrier method)",
                    "criterion": "contraception practice",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "practicing effective contraception"
                        },
                        {
                            "requirement_type": "definition",
                            "expected_value": "2 concurrent methods of contraception, 1 of which is a barrier method"
                        }
                    ]
                },
                {
                    "exact_snippets": "agrees to continue using effective contraception throughout the duration of the study",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": "continue using effective contraception throughout the duration of the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Not pregnant based on a negative result on a serum human chorionic gonadotropin (HCG) test at screening Visit 1 and a negative urine pregnancy test prevaccination at Visit 2 (and at subsequent vaccination visits);",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant based on a negative result on a serum human chorionic gonadotropin (HCG) test at screening Visit 1",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "serum HCG test result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "a negative urine pregnancy test prevaccination at Visit 2 (and at subsequent vaccination visits)",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "urine pregnancy test result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Pap test documenting atypical squamous cells of undetermined significance (ASCUS)/HPV+, atypical squamous cells high grade (ASC-H), low-grade squamous intraepithelial lesion (LSIL), or high-grade squamous intraepithelial lesion (HSIL) within 4 months prior to screening Visit 1;",
            "criterions": [
                {
                    "exact_snippets": "Pap test documenting atypical squamous cells of undetermined significance (ASCUS)/HPV+",
                    "criterion": "atypical squamous cells of undetermined significance (ASCUS)/HPV+",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pap test documenting ... atypical squamous cells high grade (ASC-H)",
                    "criterion": "atypical squamous cells high grade (ASC-H)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pap test documenting ... low-grade squamous intraepithelial lesion (LSIL)",
                    "criterion": "low-grade squamous intraepithelial lesion (LSIL)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pap test documenting ... high-grade squamous intraepithelial lesion (HSIL)",
                    "criterion": "high-grade squamous intraepithelial lesion (HSIL)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 months prior to screening Visit 1",
                    "criterion": "time since Pap test",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History of pathologically confirmed CIN1 by colposcopically-directed punch biopsy, within 12 weeks prior to administration of first study vaccination (CIN 2/3 subjects will not be eligible);",
            "criterions": [
                {
                    "exact_snippets": "History of pathologically confirmed CIN1 by colposcopically-directed punch biopsy",
                    "criterion": "CIN1",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 12 weeks prior to administration of first study vaccination",
                    "criterion": "time since biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "CIN 2/3 subjects will not be eligible",
                    "criterion": "CIN 2/3",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. For the diagnosis of CIN1, has a documented satisfactory colposcopy, ie, the entire lesion as well as the entire squamocolumnar junction is visualizible by colposcopy;",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of CIN1",
                    "criterion": "CIN1 diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented satisfactory colposcopy",
                    "criterion": "satisfactory colposcopy",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "entire lesion ... is visualizible by colposcopy",
                    "criterion": "lesion visualization",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "entire squamocolumnar junction is visualizible by colposcopy",
                    "criterion": "squamocolumnar junction visualization",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Confirmed high-risk HPV infection by a commercially available high-risk DNA assay (eg, Hybrid Capture II [Qiagen]);",
            "criterions": [
                {
                    "exact_snippets": "Confirmed high-risk HPV infection by a commercially available high-risk DNA assay",
                    "criterion": "high-risk HPV infection",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "commercially available high-risk DNA assay (eg, Hybrid Capture II [Qiagen])",
                    "criterion": "high-risk DNA assay",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Good health with adequate hematologic, renal, hepatic, and cardiac function, as determined by the Investigator, based upon medical history, physical examination, and laboratory test results at the screening visit (Visit 1):",
            "criterions": [
                {
                    "exact_snippets": "Good health",
                    "criterion": "general health",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "good"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate hematologic ... function",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hepatic ... function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bone marrow function: absolute neutrophil count ≥1,500/µL, and platelets ≥ 100,000/ µL;",
            "criterions": [
                {
                    "exact_snippets": "Bone marrow function: absolute neutrophil count ≥1,500/µL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "µL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Bone marrow function: ... platelets ≥ 100,000/ µL",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "µL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Renal function: creatinine ≤ 1.5 x institutional upper limit of normal (ULN);",
            "criterions": [
                {
                    "exact_snippets": "Renal function: creatinine ≤ 1.5 x institutional upper limit of normal (ULN);",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit of normal (ULN)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatic function: total bilirubin ≤ 1.5 x ULN (Common Terminology Criteria for AEs [CTCAE] v4.0 grade 1) except patients with Gilbert's disease (up to 5.0 mg/dL). Aspartate aminotransferase (AST) and alkaline phosphatase ≤ 2.5 x ULN.",
            "criterions": [
                {
                    "exact_snippets": "Hepatic function: total bilirubin ≤ 1.5 x ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with Gilbert's disease (up to 5.0 mg/dL)",
                    "criterion": "total bilirubin in patients with Gilbert's disease",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ... ≤ 2.5 x ULN",
                    "criterion": "Aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase ≤ 2.5 x ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal Cardiac function: as assessed by history and physical exam.",
            "criterions": [
                {
                    "exact_snippets": "Normal Cardiac function: as assessed by history and physical exam.",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "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 FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 21 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Atypical endometrial or glandular cells or evidence of invasive cervical carcinoma on cervical biopsy;",
            "criterions": [
                {
                    "exact_snippets": "Atypical endometrial or glandular cells",
                    "criterion": "atypical endometrial or glandular cells",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of invasive cervical carcinoma on cervical biopsy",
                    "criterion": "invasive cervical carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Previous history of cancer, other than adequately treated basal cell or Stage 1 squamous cell carcinoma of the skin;",
            "criterions": [
                {
                    "exact_snippets": "Previous history of cancer",
                    "criterion": "previous history of cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated basal cell or Stage 1 squamous cell carcinoma of the skin",
                    "criterion": "adequately treated basal cell or Stage 1 squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Current recognized immunodeficiency disease, including infection with HIV, cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies.",
            "criterions": [
                {
                    "exact_snippets": "Current recognized immunodeficiency disease",
                    "criterion": "immunodeficiency disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "infection with HIV",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cellular immunodeficiencies",
                    "criterion": "cellular immunodeficiencies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypogammaglobulinemia",
                    "criterion": "hypogammaglobulinemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "dysgammaglobulinemia",
                    "criterion": "dysgammaglobulinemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hereditary or congenital immunodeficiencies",
                    "criterion": "hereditary or congenital immunodeficiencies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Received immunotherapy (eg, IFNs, tumor necrosis factor, interleukins, or biological response modifiers [granulocyte-macrophage colony-stimulating factor, granulocyte colony-stimulating factor, macrophage colony-stimulating factor]) within 30 days prior to administration of the first study vaccination;",
            "criterions": [
                {
                    "exact_snippets": "Received immunotherapy (eg, IFNs, tumor necrosis factor, interleukins, or biological response modifiers [granulocyte-macrophage colony-stimulating factor, granulocyte colony-stimulating factor, macrophage colony-stimulating factor])",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 30 days prior to administration of the first study vaccination",
                    "criterion": "time since last immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Serious, concomitant disorder, including active systemic infection requiring treatment, in the opinion of the investigator;",
            "criterions": [
                {
                    "exact_snippets": "Serious, concomitant disorder",
                    "criterion": "concomitant disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "active systemic infection requiring treatment",
                    "criterion": "systemic infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Currently receiving or has received treatment with systemic steroids in the following dosages within 30 days prior to administration of the first study vaccination.",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving or has received treatment with systemic steroids",
                    "criterion": "systemic steroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "dosages within 30 days prior to administration of the first study vaccination",
                    "criterion": "systemic steroid dosage timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 30 days prior to administration of the first study vaccination"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic or long-term corticosteroids: ≥0.5 mg/kg/day of oral prednisolone or equivalent",
            "criterions": [
                {
                    "exact_snippets": "Chronic or long-term corticosteroids: ≥0.5 mg/kg/day of oral prednisolone or equivalent",
                    "criterion": "corticosteroid dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.5,
                                "unit": "mg/kg/day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sporadic corticosteroids: ≥1 mg/kg/day of oral prednisolone or equivalent for 2 or more short courses of > 3 days",
            "criterions": [
                {
                    "exact_snippets": "Sporadic corticosteroids: ≥1 mg/kg/day of oral prednisolone or equivalent",
                    "criterion": "corticosteroid dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "mg/kg/day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "2 or more short courses of > 3 days",
                    "criterion": "corticosteroid course duration",
                    "requirements": [
                        {
                            "requirement_type": "number of courses",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "courses"
                            }
                        },
                        {
                            "requirement_type": "duration per course",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Note: Current or recent use of intra-articular, topical or inhaled glucocorticoid therapy is acceptable;",
            "criterions": [
                {
                    "exact_snippets": "Current or recent use of intra-articular, topical or inhaled glucocorticoid therapy is acceptable",
                    "criterion": "glucocorticoid therapy",
                    "requirements": [
                        {
                            "requirement_type": "route of administration",
                            "expected_value": [
                                "intra-articular",
                                "topical",
                                "inhaled"
                            ]
                        },
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results;",
            "criterions": [
                {
                    "exact_snippets": "Other condition or prior therapy ... compromises the subject's welfare",
                    "criterion": "condition or prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "impact on welfare",
                            "expected_value": "compromises"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other condition or prior therapy ... may confound study results",
                    "criterion": "condition or prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "impact on study results",
                            "expected_value": "may confound"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Participation in another investigational study concurrently or use of another investigational drug within 6 months prior to administration of the first study vaccination;",
            "criterions": [
                {
                    "exact_snippets": "Participation in another investigational study concurrently",
                    "criterion": "participation in another investigational study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "use of another investigational drug within 6 months prior to administration of the first study vaccination",
                    "criterion": "use of another investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Previously enrolled in this study.",
            "criterions": [
                {
                    "exact_snippets": "Previously enrolled in this study.",
                    "criterion": "previous enrollment in this study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}