{
    "info": {
        "nct_id": "NCT05685472",
        "official_title": "A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Japanese Subjects With Advanced Solid Tumors",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion Criteria\n\n1. Age ≥ 18 years at the time of screening\n2. World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment\n3. Life expectancy ≥ 12 weeks\n4. Histologically or cytologically-confirmed advanced solid tumors\n5. Subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy or any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment may be eligible to enter the study following a washout period as applicable\n6. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception\n7. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom from Day 1 and for 90 days after the final dose of investigational product.\n8. Subjects must have at least one measurable lesion\n9. Adequate organ and marrow function\n10. Signed and dated written informed consent\n11. Subjects must provide tumor material as applicable\n\nExclusion Criteria\n\n1. Involvement in the planning and/or conduct of the study (applies to both sponsor staff and/or staff at the study site)\n2. Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study\n3. For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:\n\n   1. Subjects must not have received anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 21 days of commencing treatment with investigational product.\n   2. Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n   3. All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.\n4. Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product is excluded.\n5. Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.\n6. Active or prior documented autoimmune or inflammatory disorders\n7. History of organ transplant\n8. Known allergy or reaction to any component of the planned study treatment.\n9. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression\n10. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria\n11. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Investigational Product or still recovering from prior surgery\n12. Female subjects who are pregnant or breastfeeding, as well as male or female subjects of reproductive potential who are not willing to employ one highly effective method of birth control\n13. Uncontrolled intercurrent illness, that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.\n14. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the subject's safety or study results\n15. Judgment by the investigator that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements."
    },
    "inclusion_lines": [
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 120 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 120 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "1. Age ≥ 18 years at the time of screening",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment",
            "criterions": [
                {
                    "exact_snippets": "World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Life expectancy ≥ 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Histologically or cytologically-confirmed advanced solid tumors",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically-confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced solid tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "solid"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy or any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment may be eligible to enter the study following a washout period as applicable",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have received prior anti-PD-1 ... may be eligible to enter the study following a washout period",
                    "criterion": "prior anti-PD-1 therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have received prior ... anti-PD-L1 ... may be eligible to enter the study following a washout period",
                    "criterion": "prior anti-PD-L1 therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have received prior ... anti-CTLA-4 therapy ... may be eligible to enter the study following a washout period",
                    "criterion": "prior anti-CTLA-4 therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have received ... concurrent chemotherapy ... may be eligible to enter the study following a washout period",
                    "criterion": "concurrent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have received ... concurrent ... radiotherapy ... may be eligible to enter the study following a washout period",
                    "criterion": "concurrent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have received ... concurrent ... investigational ... therapy ... may be eligible to enter the study following a washout period",
                    "criterion": "concurrent investigational therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have received ... concurrent ... biologic ... therapy ... may be eligible to enter the study following a washout period",
                    "criterion": "concurrent biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have received ... concurrent ... hormonal therapy ... may be eligible to enter the study following a washout period",
                    "criterion": "concurrent hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception",
            "criterions": [
                {
                    "exact_snippets": "Females of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "sexually active with a nonsterilized male partner",
                    "criterion": "sexual activity and partner sterilization status",
                    "requirements": [
                        {
                            "requirement_type": "sexual activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "partner sterilization status",
                            "expected_value": "nonsterilized"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use at least one highly effective method of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "highly effective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom from Day 1 and for 90 days after the final dose of investigational product.",
            "criterions": [
                {
                    "exact_snippets": "Nonsterilized males",
                    "criterion": "male sterilization status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "nonsterilized"
                        }
                    ]
                },
                {
                    "exact_snippets": "sexually active with a female partner of childbearing potential",
                    "criterion": "sexual activity with female partner of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must use a male condom from Day 1 and for 90 days after the final dose of investigational product",
                    "criterion": "male condom use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from Day 1 and for 90 days after the final dose of investigational product"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Subjects must have at least one measurable lesion",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Adequate organ and marrow function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ and marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ and marrow function",
                    "criterion": "marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Signed and dated written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signed and dated written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "signed and dated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Subjects must provide tumor material as applicable",
            "criterions": [
                {
                    "exact_snippets": "Subjects must provide tumor material",
                    "criterion": "tumor material",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Involvement in the planning and/or conduct of the study (applies to both sponsor staff and/or staff at the study site)",
            "criterions": [
                {
                    "exact_snippets": "Involvement in the planning and/or conduct of the study",
                    "criterion": "involvement in study planning/conduct",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study",
            "criterions": [
                {
                    "exact_snippets": "Concurrent enrollment in another clinical study",
                    "criterion": "concurrent enrollment in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless it is an observational clinical study",
                    "criterion": "observational clinical study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the follow-up period of an interventional study",
                    "criterion": "follow-up period of an interventional study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:",
            "criterions": [
                {
                    "exact_snippets": "subjects who have received prior anti-PD-1",
                    "criterion": "prior anti-PD-1 treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects who have received prior ... anti-PD-L1",
                    "criterion": "prior anti-PD-L1 treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects who have received prior ... anti-CTLA-4",
                    "criterion": "prior anti-CTLA-4 treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Subjects must not have received anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 21 days of commencing treatment with investigational product.",
            "criterions": [
                {
                    "exact_snippets": "Subjects must not have received anti-PD-1",
                    "criterion": "anti-PD-1 therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects must not have received ... anti-PD-L1",
                    "criterion": "anti-PD-L1 therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects must not have received ... anti-CTLA-4",
                    "criterion": "anti-CTLA-4 therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects must not have received ... any other immunotherapy or immune-oncology (IO) agent",
                    "criterion": "other immunotherapy or immune-oncology (IO) agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 21 days of commencing treatment with investigational product",
                    "criterion": "time since last immunotherapy or IO agent",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.",
                    "criterion": "toxicity from prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not led to permanent discontinuation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.",
            "criterions": [
                {
                    "exact_snippets": "All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1",
                    "criterion": "adverse events from prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": "completely resolved"
                        },
                        {
                            "requirement_type": "resolution",
                            "expected_value": "resolved to Grade 1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product is excluded.",
            "criterions": [
                {
                    "exact_snippets": "Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product is excluded.",
                    "criterion": "use of immunosuppressive medication",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days before the first dose of investigational product"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "current or prior"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.",
                    "criterion": "live attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Active or prior documented autoimmune or inflammatory disorders",
            "criterions": [
                {
                    "exact_snippets": "Active or prior documented autoimmune or inflammatory disorders",
                    "criterion": "autoimmune or inflammatory disorders",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "prior"
                            ]
                        },
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of organ transplant",
            "criterions": [
                {
                    "exact_snippets": "History of organ transplant",
                    "criterion": "organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Known allergy or reaction to any component of the planned study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Known allergy or reaction to any component of the planned study treatment.",
                    "criterion": "allergy or reaction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression",
            "criterions": [
                {
                    "exact_snippets": "Untreated CNS metastatic disease",
                    "criterion": "CNS metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Untreated ... leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Untreated ... cord compression",
                    "criterion": "cord compression",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria",
            "criterions": [
                {
                    "exact_snippets": "Unresolved toxicities from prior anticancer therapy",
                    "criterion": "toxicities from prior anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": "NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Investigational Product or still recovering from prior surgery",
            "criterions": [
                {
                    "exact_snippets": "Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Investigational Product",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "still recovering from prior surgery",
                    "criterion": "recovery from prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Female subjects who are pregnant or breastfeeding, as well as male or female subjects of reproductive potential who are not willing to employ one highly effective method of birth control",
            "criterions": [
                {
                    "exact_snippets": "Female subjects who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "male or female subjects of reproductive potential",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not willing to employ one highly effective method of birth control",
                    "criterion": "use of birth control",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Uncontrolled intercurrent illness, that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "limit compliance with study requirement",
                    "criterion": "compliance with study requirement",
                    "requirements": [
                        {
                            "requirement_type": "limitation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "substantially increase risk of incurring AEs",
                    "criterion": "risk of incurring AEs",
                    "requirements": [
                        {
                            "requirement_type": "increase",
                            "expected_value": "substantial"
                        }
                    ]
                },
                {
                    "exact_snippets": "compromise the ability of the subject to give written informed consent",
                    "criterion": "ability to give written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "compromise",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the subject's safety or study results",
            "criterions": [
                {
                    "exact_snippets": "Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the subject's safety or study results",
                    "criterion": "condition interfering with evaluation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Judgment by the investigator that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.",
            "criterions": [
                {
                    "exact_snippets": "Judgment by the investigator that the subject is unsuitable to participate in the study",
                    "criterion": "suitability to participate",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "unsuitable"
                        }
                    ]
                },
                {
                    "exact_snippets": "the subject is unlikely to comply with study procedures, restrictions, and requirements",
                    "criterion": "compliance with study procedures, restrictions, and requirements",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "unlikely"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria",
            "criterions": []
        }
    ]
}