{
    "info": {
        "nct_id": "NCT06407401",
        "official_title": "Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer; A Pragmatic Randomized Controlled Trial",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria:\n\n* Female (both pre- and postmenopausal) or male patients\n* Age ≥18 years\n* Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI ) for ER positive HER2 negative breast cancer stages I-III\n* Patients must have received at least 3 months and up to 3 years of ET and planned to continue ET during the study conduction\n* Present endocrine therapy related MSK pain (arthralgia and/or bone pain and/or myalgias), evaluated by the treating clinician as at least grade 2 CTCAE V5.0 for, at least, 4 weeks before enrolment, at the time of the clinic visit:\n\n  * Grade 2: moderate pain; limiting instrumental activities daily living (ADL)\n  * Grade 3: severe pain; limiting activities self-care ADL\n* Previous chemotherapy is allowed if completed at least 3 months before enrolment\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* Adequate organ function\n* Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module)\n* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the first dose of study treatment.\n\nNote: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, except for those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons.\n\n* Patients of childbearing / reproductive potential must agree to use at least one acceptable effective contraceptive measure until treatment discontinuation.\n* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment.\n\nExclusion criteria:\n\n* Current history of moderate/severe depression and/or anxiety, both defined as grade≥2 CTCAE V5.0\n* History of suicide-related events\n* Current use of diuretics, antidepressants and/or phytoestrogens\n* Current use of prescribed or natural medicines with known interactions with furosemide and/or duloxetine\n* Contraindications to duloxetine:\n\n  * Severe renal impairment (creatinine clearance < 30 mL/min)\n  * Uncontrolled hypertension\n  * Hepatic impairment Child Pugh Class B or C\n* Contraindications to furosemide:\n\n  * Symptomatic hypotension, hypovolemia, or dehydration\n  * Severe renal impairment (creatinine clearance < 30 mL/min)\n  * Severe hypokalaemia and/or severe hyponatremia\n  * Addison's disease\n  * Porphyria\n* Uncontrolled intercurrent illness, including psychiatric conditions, chronic alcoholism, and drug addiction, that would, in the judgment of the investigator, limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n* Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction/motility disorder, malabsorption syndrome, or prior gastric bypass\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.\n* Participation in another interventional study with drugs."
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "* Female (both pre- and postmenopausal) or male patients",
                "criterions": [
                    {
                        "exact_snippets": "Female (both pre- and postmenopausal)",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "male patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "male"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Female (both pre- and postmenopausal)",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "male patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "male"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age ≥18 years",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI ) for ER positive HER2 negative breast cancer stages I-III",
                "criterions": [
                    {
                        "exact_snippets": "Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI )",
                        "criterion": "adjuvant endocrine therapy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    },
                    {
                        "exact_snippets": "Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI )",
                        "criterion": "adjuvant endocrine therapy",
                        "requirement": {
                            "requirement_type": "medications",
                            "expected_value": [
                                "tamoxifen",
                                "OFS plus tamoxifen",
                                "OFS plus AI",
                                "AI"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "ER positive",
                        "criterion": "ER status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "HER2 negative",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "breast cancer stages I-III",
                        "criterion": "breast cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II",
                                "III"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI )",
                                "criterion": "adjuvant endocrine therapy",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "ongoing"
                                }
                            },
                            {
                                "exact_snippets": "Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI )",
                                "criterion": "adjuvant endocrine therapy",
                                "requirement": {
                                    "requirement_type": "medications",
                                    "expected_value": [
                                        "tamoxifen",
                                        "OFS plus tamoxifen",
                                        "OFS plus AI",
                                        "AI"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "ER positive",
                        "criterion": "ER status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "HER2 negative",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "breast cancer stages I-III",
                        "criterion": "breast cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II",
                                "III"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have received at least 3 months and up to 3 years of ET and planned to continue ET during the study conduction",
                "criterions": [
                    {
                        "exact_snippets": "Patients must have received at least 3 months and up to 3 years of ET",
                        "criterion": "ET duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "planned to continue ET during the study conduction",
                        "criterion": "ET continuation",
                        "requirement": {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must have received at least 3 months and up to 3 years of ET",
                        "criterion": "ET duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "planned to continue ET during the study conduction",
                        "criterion": "ET continuation",
                        "requirement": {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Present endocrine therapy related MSK pain (arthralgia and/or bone pain and/or myalgias), evaluated by the treating clinician as at least grade 2 CTCAE V5.0 for, at least, 4 weeks before enrolment, at the time of the clinic visit:",
                "criterions": [
                    {
                        "exact_snippets": "Present endocrine therapy related MSK pain (arthralgia and/or bone pain and/or myalgias)",
                        "criterion": "endocrine therapy related MSK pain",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "evaluated by the treating clinician as at least grade 2 CTCAE V5.0",
                        "criterion": "MSK pain severity",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE V5.0"
                            }
                        }
                    },
                    {
                        "exact_snippets": "for, at least, 4 weeks before enrolment",
                        "criterion": "duration of MSK pain",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Present endocrine therapy related MSK pain (arthralgia and/or bone pain and/or myalgias)",
                        "criterion": "endocrine therapy related MSK pain",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "evaluated by the treating clinician as at least grade 2 CTCAE V5.0",
                        "criterion": "MSK pain severity",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE V5.0"
                            }
                        }
                    },
                    {
                        "exact_snippets": "for, at least, 4 weeks before enrolment",
                        "criterion": "duration of MSK pain",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Grade 2: moderate pain; limiting instrumental activities daily living (ADL)",
                "criterions": [
                    {
                        "exact_snippets": "Grade 2: moderate pain",
                        "criterion": "pain",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "moderate"
                        }
                    },
                    {
                        "exact_snippets": "Grade 2: moderate pain",
                        "criterion": "pain",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "limiting instrumental activities daily living (ADL)",
                        "criterion": "instrumental activities of daily living (ADL)",
                        "requirement": {
                            "requirement_type": "limitation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Grade 2: moderate pain",
                                "criterion": "pain",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "moderate"
                                }
                            },
                            {
                                "exact_snippets": "Grade 2: moderate pain",
                                "criterion": "pain",
                                "requirement": {
                                    "requirement_type": "grade",
                                    "expected_value": {
                                        "operator": "=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "limiting instrumental activities daily living (ADL)",
                        "criterion": "instrumental activities of daily living (ADL)",
                        "requirement": {
                            "requirement_type": "limitation",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Grade 3: severe pain; limiting activities self-care ADL",
                "criterions": [
                    {
                        "exact_snippets": "Grade 3: severe pain",
                        "criterion": "pain severity",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "limiting activities self-care ADL",
                        "criterion": "activities of daily living (ADL)",
                        "requirement": {
                            "requirement_type": "limitation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Grade 3: severe pain",
                        "criterion": "pain severity",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "limiting activities self-care ADL",
                        "criterion": "activities of daily living (ADL)",
                        "requirement": {
                            "requirement_type": "limitation",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Previous chemotherapy is allowed if completed at least 3 months before enrolment",
                "criterions": [
                    {
                        "exact_snippets": "Previous chemotherapy is allowed",
                        "criterion": "previous chemotherapy",
                        "requirement": {
                            "requirement_type": "completion time before enrolment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Previous chemotherapy is allowed",
                        "criterion": "previous chemotherapy",
                        "requirement": {
                            "requirement_type": "completion time before enrolment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate organ function",
                "criterions": [
                    {
                        "exact_snippets": "Adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module)",
                "criterions": [
                    {
                        "exact_snippets": "Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module)",
                        "criterion": "baseline assessment of patient-reported questionnaires",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module)",
                        "criterion": "baseline assessment of patient-reported questionnaires",
                        "requirement": {
                            "requirement_type": "questionnaires",
                            "expected_value": [
                                "EORTC QLQ-C30",
                                "EORTC QLQ breast module"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module)",
                        "criterion": "baseline assessment of patient-reported questionnaires",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module)",
                        "criterion": "baseline assessment of patient-reported questionnaires",
                        "requirement": {
                            "requirement_type": "questionnaires",
                            "expected_value": [
                                "EORTC QLQ-C30",
                                "EORTC QLQ breast module"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations",
                "criterions": [
                    {
                        "exact_snippets": "written informed consent must be given",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "according to ICH/GCP, and national/local regulations",
                        "criterion": "compliance with regulations",
                        "requirement": {
                            "requirement_type": "standards",
                            "expected_value": [
                                "ICH/GCP",
                                "national/local regulations"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "written informed consent must be given",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "according to ICH/GCP, and national/local regulations",
                        "criterion": "compliance with regulations",
                        "requirement": {
                            "requirement_type": "standards",
                            "expected_value": [
                                "ICH/GCP",
                                "national/local regulations"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the first dose of study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Women of childbearing potential (WOCBP)",
                        "criterion": "women of childbearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must have a negative serum or urine pregnancy test",
                        "criterion": "pregnancy test result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "within 7 days prior to the first dose of study treatment",
                        "criterion": "timing of pregnancy test",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to the first dose of study treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Women of childbearing potential (WOCBP)",
                    "criterion": "women of childbearing potential",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "must have a negative serum or urine pregnancy test",
                            "criterion": "pregnancy test result",
                            "requirement": {
                                "requirement_type": "result",
                                "expected_value": "negative"
                            }
                        },
                        {
                            "exact_snippets": "within 7 days prior to the first dose of study treatment",
                            "criterion": "timing of pregnancy test",
                            "requirement": {
                                "requirement_type": "timing",
                                "expected_value": "within 7 days prior to the first dose of study treatment"
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Patients of childbearing / reproductive potential must agree to use at least one acceptable effective contraceptive measure until treatment discontinuation.",
                "criterions": [
                    {
                        "exact_snippets": "Patients of childbearing / reproductive potential",
                        "criterion": "childbearing/reproductive potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must agree to use at least one acceptable effective contraceptive measure until treatment discontinuation",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must agree to use at least one acceptable effective contraceptive measure until treatment discontinuation",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "until treatment discontinuation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Patients of childbearing / reproductive potential",
                    "criterion": "childbearing/reproductive potential",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "must agree to use at least one acceptable effective contraceptive measure until treatment discontinuation",
                            "criterion": "contraceptive use",
                            "requirement": {
                                "requirement_type": "agreement",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "must agree to use at least one acceptable effective contraceptive measure until treatment discontinuation",
                            "criterion": "contraceptive use",
                            "requirement": {
                                "requirement_type": "duration",
                                "expected_value": "until treatment discontinuation"
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Female subjects who are breast feeding",
                        "criterion": "breast feeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment",
                        "criterion": "nursing",
                        "requirement": {
                            "requirement_type": "discontinuation period",
                            "expected_value": "prior to the first dose of study treatment and until 1 month after the last study treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Female subjects who are breast feeding",
                    "criterion": "breast feeding",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment",
                    "criterion": "nursing",
                    "requirement": {
                        "requirement_type": "discontinuation period",
                        "expected_value": "prior to the first dose of study treatment and until 1 month after the last study treatment"
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Current history of moderate/severe depression and/or anxiety, both defined as grade≥2 CTCAE V5.0",
                "criterions": [
                    {
                        "exact_snippets": "Current history of moderate/severe depression ... grade≥2 CTCAE V5.0",
                        "criterion": "depression",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE V5.0"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Current history of ... anxiety, ... grade≥2 CTCAE V5.0",
                        "criterion": "anxiety",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE V5.0"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Current history of moderate/severe depression ... grade≥2 CTCAE V5.0",
                                "criterion": "depression",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "CTCAE V5.0"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Current history of ... anxiety, ... grade≥2 CTCAE V5.0",
                                "criterion": "anxiety",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "CTCAE V5.0"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of suicide-related events",
                "criterions": [
                    {
                        "exact_snippets": "History of suicide-related events",
                        "criterion": "suicide-related events",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "History of suicide-related events",
                        "criterion": "suicide-related events",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Current use of diuretics, antidepressants and/or phytoestrogens",
                "criterions": [
                    {
                        "exact_snippets": "Current use of diuretics",
                        "criterion": "diuretics",
                        "requirement": {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Current use of ... antidepressants",
                        "criterion": "antidepressants",
                        "requirement": {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Current use of ... phytoestrogens",
                        "criterion": "phytoestrogens",
                        "requirement": {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Current use of diuretics",
                                "criterion": "diuretics",
                                "requirement": {
                                    "requirement_type": "current use",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Current use of ... antidepressants",
                                "criterion": "antidepressants",
                                "requirement": {
                                    "requirement_type": "current use",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Current use of ... phytoestrogens",
                        "criterion": "phytoestrogens",
                        "requirement": {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Current use of prescribed or natural medicines with known interactions with furosemide and/or duloxetine",
                "criterions": [
                    {
                        "exact_snippets": "Current use of prescribed or natural medicines with known interactions with furosemide",
                        "criterion": "use of medicines with interactions with furosemide",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Current use of prescribed or natural medicines with known interactions with ... duloxetine",
                        "criterion": "use of medicines with interactions with duloxetine",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Current use of prescribed or natural medicines with known interactions with furosemide",
                        "criterion": "use of medicines with interactions with furosemide",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Current use of prescribed or natural medicines with known interactions with ... duloxetine",
                        "criterion": "use of medicines with interactions with duloxetine",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Contraindications to duloxetine:",
                "criterions": [
                    {
                        "exact_snippets": "Contraindications to duloxetine",
                        "criterion": "contraindications to duloxetine",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Contraindications to duloxetine",
                        "criterion": "contraindications to duloxetine",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled hypertension",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Uncontrolled hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hepatic impairment Child Pugh Class B or C",
                "criterions": [
                    {
                        "exact_snippets": "Hepatic impairment Child Pugh Class B or C",
                        "criterion": "hepatic impairment",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "Child Pugh Class B",
                                "Child Pugh Class C"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hepatic impairment Child Pugh Class B or C",
                        "criterion": "hepatic impairment",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "Child Pugh Class B",
                                "Child Pugh Class C"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction/motility disorder, malabsorption syndrome, or prior gastric bypass",
                "criterions": [
                    {
                        "exact_snippets": "Known difficulty in tolerating oral medications",
                        "criterion": "tolerance to oral medications",
                        "requirement": {
                            "requirement_type": "difficulty",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "conditions which would impair absorption of oral medications",
                        "criterion": "absorption of oral medications",
                        "requirement": {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy)",
                        "criterion": "nausea or vomiting",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy)",
                        "criterion": "nausea or vomiting",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "CTCAE Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ongoing gastrointestinal obstruction/motility disorder",
                        "criterion": "gastrointestinal obstruction/motility disorder",
                        "requirement": {
                            "requirement_type": "ongoing",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "malabsorption syndrome",
                        "criterion": "malabsorption syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior gastric bypass",
                        "criterion": "gastric bypass",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Known difficulty in tolerating oral medications",
                                "criterion": "tolerance to oral medications",
                                "requirement": {
                                    "requirement_type": "difficulty",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "conditions which would impair absorption of oral medications",
                                "criterion": "absorption of oral medications",
                                "requirement": {
                                    "requirement_type": "impairment",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy)",
                                "criterion": "nausea or vomiting",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy)",
                                "criterion": "nausea or vomiting",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "CTCAE Grade"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "ongoing gastrointestinal obstruction/motility disorder",
                        "criterion": "gastrointestinal obstruction/motility disorder",
                        "requirement": {
                            "requirement_type": "ongoing",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "malabsorption syndrome",
                        "criterion": "malabsorption syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior gastric bypass",
                        "criterion": "gastric bypass",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.",
                "criterions": [
                    {
                        "exact_snippets": "psychological ... condition potentially hampering compliance",
                        "criterion": "psychological condition",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "familial ... condition potentially hampering compliance",
                        "criterion": "familial condition",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "sociological ... condition potentially hampering compliance",
                        "criterion": "sociological condition",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "geographical condition potentially hampering compliance",
                        "criterion": "geographical condition",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "psychological ... condition potentially hampering compliance",
                                "criterion": "psychological condition",
                                "requirement": {
                                    "requirement_type": "impact on compliance",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "familial ... condition potentially hampering compliance",
                                "criterion": "familial condition",
                                "requirement": {
                                    "requirement_type": "impact on compliance",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "sociological ... condition potentially hampering compliance",
                                "criterion": "sociological condition",
                                "requirement": {
                                    "requirement_type": "impact on compliance",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "geographical condition potentially hampering compliance",
                                "criterion": "geographical condition",
                                "requirement": {
                                    "requirement_type": "impact on compliance",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participation in another interventional study with drugs.",
                "criterions": [
                    {
                        "exact_snippets": "Participation in another interventional study with drugs",
                        "criterion": "participation in another interventional study",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Participation in another interventional study with drugs",
                        "criterion": "participation in another interventional study",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Inclusion criteria:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "Exclusion criteria:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "* Severe renal impairment (creatinine clearance &lt; 30 mL/min)",
                "criterions": [
                    {
                        "exact_snippets": "Severe renal impairment",
                        "criterion": "renal impairment",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance < 30 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Severe renal impairment",
                        "criterion": "renal impairment",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance < 30 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Severe renal impairment (creatinine clearance &lt; 30 mL/min)",
                "criterions": [
                    {
                        "exact_snippets": "Severe renal impairment",
                        "criterion": "renal impairment",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance < 30 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Severe renal impairment",
                        "criterion": "renal impairment",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance < 30 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, except for those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons.",
                "criterions": [
                    {
                        "exact_snippets": "premenopausal females",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    },
                    {
                        "exact_snippets": "capable of becoming pregnant",
                        "criterion": "pregnancy capability",
                        "requirement": {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "females who have had any evidence of menses in the past 12 months",
                        "criterion": "menstrual history",
                        "requirement": {
                            "requirement_type": "evidence of menses",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "times in the past 12 months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "except for those who had prior hysterectomy",
                        "criterion": "hysterectomy history",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "women who have been amenorrhoeic for 12 or more months",
                        "criterion": "amenorrhea duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons",
                        "criterion": "amenorrhea cause",
                        "requirement": {
                            "requirement_type": "possible causes",
                            "expected_value": [
                                "prior chemotherapy",
                                "antioestrogens",
                                "low body weight",
                                "ovarian suppression",
                                "other reasons"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "exact_snippets": "premenopausal females",
                                                                "criterion": "menopausal status",
                                                                "requirement": {
                                                                    "requirement_type": "status",
                                                                    "expected_value": "premenopausal"
                                                                }
                                                            },
                                                            {
                                                                "exact_snippets": "capable of becoming pregnant",
                                                                "criterion": "pregnancy capability",
                                                                "requirement": {
                                                                    "requirement_type": "capability",
                                                                    "expected_value": true
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "females who have had any evidence of menses in the past 12 months",
                                                        "criterion": "menstrual history",
                                                        "requirement": {
                                                            "requirement_type": "evidence of menses",
                                                            "expected_value": {
                                                                "operator": ">=",
                                                                "value": 1,
                                                                "unit": "times in the past 12 months"
                                                            }
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "not_criteria": {
                                                    "exact_snippets": "except for those who had prior hysterectomy",
                                                    "criterion": "hysterectomy history",
                                                    "requirement": {
                                                        "requirement_type": "history",
                                                        "expected_value": true
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "not_criteria": {
                                            "and_criteria": [
                                                {
                                                    "exact_snippets": "women who have been amenorrhoeic for 12 or more months",
                                                    "criterion": "amenorrhea duration",
                                                    "requirement": {
                                                        "requirement_type": "duration",
                                                        "expected_value": {
                                                            "operator": ">=",
                                                            "value": 12,
                                                            "unit": "months"
                                                        }
                                                    }
                                                },
                                                {
                                                    "exact_snippets": "amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons",
                                                    "criterion": "amenorrhea cause",
                                                    "requirement": {
                                                        "requirement_type": "possible causes",
                                                        "expected_value": [
                                                            "prior chemotherapy",
                                                            "antioestrogens",
                                                            "low body weight",
                                                            "ovarian suppression",
                                                            "other reasons"
                                                        ]
                                                    }
                                                }
                                            ]
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Contraindications to furosemide:",
                "criterions": [
                    {
                        "exact_snippets": "Contraindications to furosemide",
                        "criterion": "contraindications to furosemide",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Symptomatic hypotension, hypovolemia, or dehydration",
                "criterions": [
                    {
                        "exact_snippets": "Symptomatic hypotension",
                        "criterion": "hypotension",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypovolemia",
                        "criterion": "hypovolemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "dehydration",
                        "criterion": "dehydration",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Severe hypokalaemia and/or severe hyponatremia",
                "criterions": [
                    {
                        "exact_snippets": "Severe hypokalaemia",
                        "criterion": "hypokalaemia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "severe hyponatremia",
                        "criterion": "hyponatremia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Addison's disease",
                "criterions": [
                    {
                        "exact_snippets": "Addison's disease",
                        "criterion": "Addison's disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Porphyria",
                "criterions": [
                    {
                        "exact_snippets": "Porphyria",
                        "criterion": "porphyria",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled intercurrent illness, including psychiatric conditions, chronic alcoholism, and drug addiction, that would, in the judgment of the investigator, limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness",
                        "criterion": "intercurrent illness",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "psychiatric conditions",
                        "criterion": "psychiatric conditions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "chronic alcoholism",
                        "criterion": "chronic alcoholism",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "drug addiction",
                        "criterion": "drug addiction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ]
}