{
    "info": {
        "nct_id": "NCT06561620",
        "official_title": "A Prospective Study of Befotertinib Adjuvant Therapy in Patients With Postoperative MRD-positive Non-small Cell Lung Cancer in Stage IA2-IB With High Risk Factors",
        "inclusion_criteria": "1. Age: 18-75 years old.\n2. Gender: both men and women are acceptable, as balanced as possible.\n3. Patients with lung adenocarcinoma who underwent R0 resection and were clinically confirmed as IA2-IB by histopathology and whose tumor size was (1-4cm), the surgical tissue samples tested positive for EGFR-sensitive mutations and positive for MRD after surgery.\n4. Accompanied by arbitrary ≥ 2 high-risk factors; High risk factors such as pleural invasion, airway diffusion, vascular infiltration, low differentiation, pathological micropapillary composition ≥ 15%, complex glandular composition ≥ 20%, etc.\n\n4. Achieve R0 resection: For CTR < 50% ground glass nodules, wedge resection is acceptable and the margin is negative, and 3 groups of lymph node biopsies are negative; for CTR ≥ 50% or pure solid nodules, at least segmental resection is undergone, and lymph node dissection is systematically performed; if there is no clear evidence of metastasis, if it cannot be judged, it can be determined by an independent review committee for pathological consultation.\n\n5. The ECOG behavioral status score is 0 to 1, and the expected survival time is > 1 year.\n\n6. Voluntary MRD screening and voluntary befortinib adjuvant therapy; 7. Have a certain organ system function, defined as follows, based on the researcher's experience A. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L B. Platelets ≥ 100 x 109/L; C. Hemoglobin ≥ 9 g/dL (≥ 90 g/L) Note that in order to achieve the required hemoglobin level, blood transfusion is allowed; D. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); E. If there is no liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; if liver metastasis, ≤ 5 × ULN; F. Creatinine ≤ 1.5 x ULN. Patients are still eligible for inclusion if the creatinine clearance value calculated by the Cockcroft-Gault method is ≥ 50 mL/min (0.83 mL/s).\n\n8. Female subjects of childbearing age must have a serum pregnancy test within 3 days before the start of the study drug, and the result is negative, and they are willing to use a medically approved high-efficacy contraceptive method (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last administration of the study drug; for significant other male subjects who are women of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study period and within 3 months after the last study dose.\n\n9. Voluntary and capable of following the test and follow-up procedures. 10. Sign the informed consent form.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. There is any other treatment before the operation, and no informed consent is signed;\n2. The patient has been diagnosed with cancer within 2 years;\n3. Have a history of interstitial lung disease, drug-induced interstitial disease or any active interstitial lung disease with clinical evidence; CT scan at baseline revealed idiopathic pulmonary fibrosis.\n4. Patients who are known to be allergic to any component of befortinib or similar drugs;\n5. Pregnant or lactating women;\n6. Situations considered unsuitable for inclusion by other researchers.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age: 18-75 years old.",
            "criterions": [
                {
                    "exact_snippets": "Age: 18-75 years old.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Gender: both men and women are acceptable, as balanced as possible.",
            "criterions": [
                {
                    "exact_snippets": "Gender: both men and women are acceptable",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "acceptable genders",
                            "expected_value": [
                                "men",
                                "women"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "as balanced as possible",
                    "criterion": "gender balance",
                    "requirements": [
                        {
                            "requirement_type": "balance",
                            "expected_value": "as balanced as possible"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with lung adenocarcinoma who underwent R0 resection and were clinically confirmed as IA2-IB by histopathology and whose tumor size was (1-4cm), the surgical tissue samples tested positive for EGFR-sensitive mutations and positive for MRD after surgery.",
            "criterions": [
                {
                    "exact_snippets": "Patients with lung adenocarcinoma",
                    "criterion": "lung adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "underwent R0 resection",
                    "criterion": "R0 resection",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically confirmed as IA2-IB by histopathology",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IA2",
                                "IB"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor size was (1-4cm)",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "cm"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "cm"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical tissue samples tested positive for EGFR-sensitive mutations",
                    "criterion": "EGFR-sensitive mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive for MRD after surgery",
                    "criterion": "MRD (Minimal Residual Disease)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Accompanied by arbitrary ≥ 2 high-risk factors; High risk factors such as pleural invasion, airway diffusion, vascular infiltration, low differentiation, pathological micropapillary composition ≥ 15%, complex glandular composition ≥ 20%, etc.",
            "criterions": [
                {
                    "exact_snippets": "pleural invasion",
                    "criterion": "pleural invasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "airway diffusion",
                    "criterion": "airway diffusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "vascular infiltration",
                    "criterion": "vascular infiltration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "low differentiation",
                    "criterion": "low differentiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pathological micropapillary composition ≥ 15%",
                    "criterion": "pathological micropapillary composition",
                    "requirements": [
                        {
                            "requirement_type": "composition",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "complex glandular composition ≥ 20%",
                    "criterion": "complex glandular composition",
                    "requirements": [
                        {
                            "requirement_type": "composition",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Achieve R0 resection: For CTR < 50% ground glass nodules, wedge resection is acceptable and the margin is negative, and 3 groups of lymph node biopsies are negative; for CTR ≥ 50% or pure solid nodules, at least segmental resection is undergone, and lymph node dissection is systematically performed; if there is no clear evidence of metastasis, if it cannot be judged, it can be determined by an independent review committee for pathological consultation.",
            "criterions": [
                {
                    "exact_snippets": "CTR < 50% ground glass nodules",
                    "criterion": "CTR ground glass nodules",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "ground glass"
                        }
                    ]
                },
                {
                    "exact_snippets": "wedge resection is acceptable",
                    "criterion": "wedge resection",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the margin is negative",
                    "criterion": "resection margin",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "3 groups of lymph node biopsies are negative",
                    "criterion": "lymph node biopsies",
                    "requirements": [
                        {
                            "requirement_type": "number of groups",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "groups"
                            }
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "CTR ≥ 50% or pure solid nodules",
                    "criterion": "CTR solid nodules",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "solid"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least segmental resection is undergone",
                    "criterion": "segmental resection",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lymph node dissection is systematically performed",
                    "criterion": "lymph node dissection",
                    "requirements": [
                        {
                            "requirement_type": "systematic performance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no clear evidence of metastasis",
                    "criterion": "evidence of metastasis",
                    "requirements": [
                        {
                            "requirement_type": "clarity",
                            "expected_value": "none"
                        }
                    ]
                },
                {
                    "exact_snippets": "determined by an independent review committee for pathological consultation",
                    "criterion": "independent review committee determination",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. The ECOG behavioral status score is 0 to 1, and the expected survival time is > 1 year.",
            "criterions": [
                {
                    "exact_snippets": "ECOG behavioral status score is 0 to 1",
                    "criterion": "ECOG behavioral status score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "expected survival time is > 1 year",
                    "criterion": "expected survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Voluntary MRD screening and voluntary befortinib adjuvant therapy; 7. Have a certain organ system function, defined as follows, based on the researcher's experience A. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L B. Platelets ≥ 100 x 109/L; C. Hemoglobin ≥ 9 g/dL (≥ 90 g/L) Note that in order to achieve the required hemoglobin level, blood transfusion is allowed; D. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); E. If there is no liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; if liver metastasis, ≤ 5 × ULN; F. Creatinine ≤ 1.5 x ULN. Patients are still eligible for inclusion if the creatinine clearance value calculated by the Cockcroft-Gault method is ≥ 50 mL/min (0.83 mL/s).",
            "criterions": [
                {
                    "exact_snippets": "Voluntary MRD screening",
                    "criterion": "MRD screening",
                    "requirements": [
                        {
                            "requirement_type": "voluntary",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntary befortinib adjuvant therapy",
                    "criterion": "befortinib adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "voluntary",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 x 109/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets ≥ 100 x 109/L",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin ≥ 9 g/dL (≥ 90 g/L)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; if liver metastasis, ≤ 5 × ULN",
                    "criterion": "alanine aminotransferase (ALT) and aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine ≤ 1.5 x ULN",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance value calculated by the Cockcroft-Gault method is ≥ 50 mL/min (0.83 mL/s)",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Female subjects of childbearing age must have a serum pregnancy test within 3 days before the start of the study drug, and the result is negative, and they are willing to use a medically approved high-efficacy contraceptive method (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last administration of the study drug; for significant other male subjects who are women of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study period and within 3 months after the last study dose.",
            "criterions": [
                {
                    "exact_snippets": "Female subjects of childbearing age",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing age"
                        }
                    ]
                },
                {
                    "exact_snippets": "serum pregnancy test within 3 days before the start of the study drug, and the result is negative",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 3 days before the start of the study drug"
                        },
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to use a medically approved high-efficacy contraceptive method (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last administration of the study drug",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "intrauterine devices",
                                "contraceptives",
                                "condoms"
                            ]
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study period and within 3 months after the last administration of the study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant other male subjects who are women of childbearing age",
                    "criterion": "significant other gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "male"
                        },
                        {
                            "requirement_type": "partner reproductive status",
                            "expected_value": "women of childbearing age"
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically sterilized, or agree to use effective methods of contraception during the study period and within 3 months after the last study dose",
                    "criterion": "contraceptive or sterilization status",
                    "requirements": [
                        {
                            "requirement_type": "sterilization",
                            "expected_value": "surgically sterilized"
                        },
                        {
                            "requirement_type": "contraceptive use",
                            "expected_value": "agree to use effective methods of contraception"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study period and within 3 months after the last study dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Voluntary and capable of following the test and follow-up procedures. 10. Sign the informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "Voluntary",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "capable of following the test and follow-up procedures",
                    "criterion": "capability to follow procedures",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Sign the informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must 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 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. There is any other treatment before the operation, and no informed consent is signed;",
            "criterions": [
                {
                    "exact_snippets": "any other treatment before the operation",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no informed consent is signed",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. The patient has been diagnosed with cancer within 2 years;",
            "criterions": [
                {
                    "exact_snippets": "The patient has been diagnosed with cancer within 2 years",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Have a history of interstitial lung disease, drug-induced interstitial disease or any active interstitial lung disease with clinical evidence; CT scan at baseline revealed idiopathic pulmonary fibrosis.",
            "criterions": [
                {
                    "exact_snippets": "history of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "drug-induced interstitial disease",
                    "criterion": "drug-induced interstitial disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any active interstitial lung disease with clinical evidence",
                    "criterion": "active interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CT scan at baseline revealed idiopathic pulmonary fibrosis",
                    "criterion": "idiopathic pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients who are known to be allergic to any component of befortinib or similar drugs;",
            "criterions": [
                {
                    "exact_snippets": "Patients who are known to be allergic to any component of befortinib",
                    "criterion": "allergy to befortinib components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... similar drugs",
                    "criterion": "allergy to similar drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Pregnant or lactating women;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Situations considered unsuitable for inclusion by other researchers.",
            "criterions": [
                {
                    "exact_snippets": "Situations considered unsuitable for inclusion by other researchers.",
                    "criterion": "suitability for inclusion",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": "unsuitable by other researchers"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}