{
    "info": {
        "nct_id": "NCT00543712",
        "official_title": "A Phase II, Open-Label, Multicenter Study of the Efficacy and Safety of Single-Agent PRO95780 in Patients With Advanced Chondrosarcoma",
        "inclusion_criteria": "* Ability to understand and willingness to sign a written informed consent document\n* Age ≥ 18 years\n* Histologic diagnosis of chondrosarcoma, verifiable after enrollment\n* Measurable disease\n* Previously treated or incurable disease without options for standard of care therapy\n* ECOG performance status of 0-2\n* Life expectancy of > 3 months\n* For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) throughout the trial and for 1 year following their final exposure to study treatment\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Systemic therapy or radiotherapy within 4 weeks prior to Day 1\n* Prior therapy with agents targeting the DR5 apoptosis pathway\n* Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study\n* Other invasive malignancies within 5 years prior to Day 1\n* Known active brain metastases\n* Uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring parenteral antibiotics at enrollment\n* Clinically significant, symptomatic cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia, Grade II or greater peripheral vascular disease, or history of major heart surgery within 6 months of Day 1, or any situation that would likely limit compliance with study requirements\n* Known to be positive for hepatitis C or hepatitis B surface antigen\n* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications\n* Use of anticoagulation therapy\n* Participation in clinical trials or undergoing other investigational procedures within 30 days prior to Day 1\n* Pregnancy or breast feeding\n* Known sensitivity to any of the products administered during the study\n* Any disorder that compromises the ability of the patient to give written informed consent and/or comply with study procedures",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Ability to understand and willingness to sign a written informed consent document",
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                    {
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                            "Ability to understand"
                        ],
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                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "willingness to sign a written informed consent document"
                        ],
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                        "expected_value": true
                    }
                ]
            },
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                            "Ability to understand"
                        ],
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                    },
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                            "willingness to sign a written informed consent document"
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                        "requirement_type": "willingness to sign",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age ≥ 18 years",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Age ≥ 18 years"
                        ],
                        "criterion": "age",
                        "requirement_type": "N/A",
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                                {
                                    "operator": ">=",
                                    "value": 18
                                }
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                            "Age ≥ 18 years"
                        ],
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                                    "operator": ">=",
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                        }
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                ]
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        },
        {
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                "line": "* Histologic diagnosis of chondrosarcoma, verifiable after enrollment",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Histologic diagnosis of chondrosarcoma"
                        ],
                        "criterion": "chondrosarcoma",
                        "requirement_type": "diagnosis",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Histologic diagnosis of chondrosarcoma"
                        ],
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                        "requirement_type": "diagnosis",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Measurable disease",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Measurable disease"
                        ],
                        "criterion": "disease",
                        "requirement_type": "measurability",
                        "expected_value": true
                    }
                ]
            },
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                    {
                        "exact_snippets": [
                            "Measurable disease"
                        ],
                        "criterion": "disease",
                        "requirement_type": "measurability",
                        "expected_value": true
                    }
                ]
            }
        },
        {
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                "line": "* Previously treated or incurable disease without options for standard of care therapy",
                "criterions": [
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                        "exact_snippets": [
                            "Previously treated"
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                        "requirement_type": "treatment history",
                        "expected_value": "previously treated"
                    },
                    {
                        "exact_snippets": [
                            "incurable disease"
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                        "criterion": "disease",
                        "requirement_type": "curability",
                        "expected_value": "incurable"
                    },
                    {
                        "exact_snippets": [
                            "without options for standard of care therapy"
                        ],
                        "criterion": "standard of care therapy options",
                        "requirement_type": "availability",
                        "expected_value": false
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                ]
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                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Previously treated"
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                                "requirement_type": "treatment history",
                                "expected_value": "previously treated"
                            },
                            {
                                "exact_snippets": [
                                    "without options for standard of care therapy"
                                ],
                                "criterion": "standard of care therapy options",
                                "requirement_type": "availability",
                                "expected_value": false
                            }
                        ]
                    },
                    {
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                                "exact_snippets": [
                                    "incurable disease"
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                                "requirement_type": "curability",
                                "expected_value": "incurable"
                            },
                            {
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                                    "without options for standard of care therapy"
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                                "requirement_type": "availability",
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                ]
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        },
        {
            "identified_line": {
                "line": "* ECOG performance status of 0-2",
                "criterions": [
                    {
                        "exact_snippets": [
                            "ECOG performance status of 0-2"
                        ],
                        "criterion": "ECOG performance status",
                        "requirement_type": "range",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 0
                                },
                                {
                                    "operator": "<=",
                                    "value": 2
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": [
                            "ECOG performance status of 0-2"
                        ],
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                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 0
                                },
                                {
                                    "operator": "<=",
                                    "value": 2
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy of > 3 months",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Life expectancy of > 3 months"
                        ],
                        "criterion": "life expectancy",
                        "requirement_type": "duration",
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                            "comparisons": [
                                {
                                    "operator": ">",
                                    "value": 3
                                }
                            ]
                        }
                    }
                ]
            },
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                    {
                        "exact_snippets": [
                            "Life expectancy of > 3 months"
                        ],
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                            "comparisons": [
                                {
                                    "operator": ">",
                                    "value": 3
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) throughout the trial and for 1 year following their final exposure to study treatment",
                "criterions": [
                    {
                        "exact_snippets": [
                            "patients of reproductive potential"
                        ],
                        "criterion": "reproductive potential",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
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                            "use of reliable means for contraception"
                        ],
                        "criterion": "contraception",
                        "requirement_type": "use",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "throughout the trial and for 1 year following their final exposure to study treatment"
                        ],
                        "criterion": "contraception duration",
                        "requirement_type": "duration",
                        "expected_value": "throughout the trial and for 1 year following their final exposure to study treatment"
                    }
                ]
            },
            "logical_structure": {
                "condition": {
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                        {
                            "exact_snippets": [
                                "patients of reproductive potential"
                            ],
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
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                                "use of reliable means for contraception"
                            ],
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                            "requirement_type": "use",
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                        },
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                            ],
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                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Healthy volunteers allowed"
                        ],
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                        "requirement_type": "allowance",
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                    }
                ]
            },
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                            "Healthy volunteers allowed"
                        ],
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                    }
                ]
            }
        },
        {
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                    {
                        "exact_snippets": [
                            "minimum age of 18 Years"
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                        }
                    }
                ]
            },
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                            "minimum age of 18 Years"
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                        }
                    }
                ]
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    ],
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        {
            "identified_line": {
                "line": "* Systemic therapy or radiotherapy within 4 weeks prior to Day 1",
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                    {
                        "exact_snippets": [
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                            "within 4 weeks prior to Day 1"
                        ],
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                                    "operator": ">=",
                                    "value": 4
                                }
                            ]
                        }
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        },
        {
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                        "exact_snippets": [
                            "Prior therapy with agents targeting the DR5 apoptosis pathway"
                        ],
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                    }
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                }
            }
        },
        {
            "identified_line": {
                "line": "* Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study",
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                            "Major surgical procedure",
                            "within 4 weeks prior to Day 1"
                        ],
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                        "requirement_type": "timing",
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                    },
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                        "exact_snippets": [
                            "open biopsy",
                            "within 4 weeks prior to Day 1"
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                            "within 4 weeks prior to Day 1"
                        ],
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                    },
                    {
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                            "anticipation of need for major surgical procedure",
                            "during the course of the study"
                        ],
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                        "requirement_type": "anticipated need",
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                    }
                ]
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                            {
                                "exact_snippets": [
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                                    "within 4 weeks prior to Day 1"
                                ],
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                                "requirement_type": "timing",
                                "expected_value": "within 4 weeks prior to Day 1"
                            },
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                                    "open biopsy",
                                    "within 4 weeks prior to Day 1"
                                ],
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                                "requirement_type": "timing",
                                "expected_value": "within 4 weeks prior to Day 1"
                            },
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                                    "within 4 weeks prior to Day 1"
                                ],
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                                "requirement_type": "timing",
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Other invasive malignancies within 5 years prior to Day 1",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Other invasive malignancies within 5 years prior to Day 1"
                        ],
                        "criterion": "invasive malignancies",
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                ]
            },
            "logical_structure": {
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                    "exact_snippets": [
                        "Other invasive malignancies within 5 years prior to Day 1"
                    ],
                    "criterion": "invasive malignancies",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            }
        },
        {
            "identified_line": {
                "line": "* Known active brain metastases",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Known active brain metastases"
                        ],
                        "criterion": "brain metastases",
                        "requirement_type": "activity",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
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                    "exact_snippets": [
                        "Known active brain metastases"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "activity",
                    "expected_value": true
                }
            }
        },
        {
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                "line": "* Clinically significant, symptomatic cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia, Grade II or greater peripheral vascular disease, or history of major heart surgery within 6 months of Day 1, or any situation that would likely limit compliance with study requirements",
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                    {
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                        ],
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                    },
                    {
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                            "New York Heart Association (NYHA) Grade II or greater congestive heart failure"
                        ],
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                                    "operator": ">=",
                                    "value": 2
                                }
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                        ],
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                    },
                    {
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                        ],
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                                    "operator": ">=",
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                                }
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                            "history of major heart surgery within 6 months of Day 1"
                        ],
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                    },
                    {
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                                ],
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                                    "history of major heart surgery within 6 months of Day 1"
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                            }
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        },
        {
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                "line": "* Use of anticoagulation therapy",
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                    {
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                            "Use of anticoagulation therapy"
                        ],
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                    }
                ]
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                }
            }
        },
        {
            "identified_line": {
                "line": "* Participation in clinical trials or undergoing other investigational procedures within 30 days prior to Day 1",
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                    {
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                            "Participation in clinical trials"
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        },
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                        ],
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                    },
                    {
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                    {
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                ]
            }
        },
        {
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                "criterions": [
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                    },
                    {
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                        ],
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                    },
                    {
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                        ],
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                ]
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                                ]
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                ]
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        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
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                    {
                        "exact_snippets": [
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                        ],
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                ]
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        }
    ],
    "failed_miscellaneous": []
}