{
    "info": {
        "nct_id": "NCT04244773",
        "official_title": "Substudy of Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (ESTxENDS Trial)- the Micronuclei Substudy of ESTxENDS",
        "inclusion_criteria": "* Informed Consent as documented by signature\n* Persons aged 18 or older\n* Currently smoking 5 or more cigarettes a day for at least 12 months\n* Willing to try to quit smoking within the next 3 months,\n* Persons providing a valid phone number, a valid email address and/or a valid postal address.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Known hypersensitivity or allergy to contents of the e-liquid Participation in another study with investigational drug within the 30 days preceding the baseline visit and during the present study where interactions are to be expected\n\n* Women who are pregnant or breast feeding\n* Intention to become pregnant during the course of the scheduled study intervention, i.e. within the first 6-months of the study\n* Persons having used ENDS regularly in the 3 months preceding the baseline visit\n* Persons having used nicotine replacement therapy (NRT) or other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion within the 3 months preceding the baseline visit\n* Persons who cannot attend the 6- month follow-up visit for any reason\n* Cannot understand instructions delivered in person or by phone, or otherwise unable to participate in study procedures",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Informed Consent as documented by signature",
            "criterions": [
                {
                    "exact_snippets": "Informed Consent as documented by signature",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "signature"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Persons aged 18 or older",
            "criterions": [
                {
                    "exact_snippets": "aged 18 or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently smoking 5 or more cigarettes a day for at least 12 months",
            "criterions": [
                {
                    "exact_snippets": "Currently smoking 5 or more cigarettes a day",
                    "criterion": "cigarette smoking",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "cigarettes per day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "for at least 12 months",
                    "criterion": "duration of smoking",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to try to quit smoking within the next 3 months,",
            "criterions": [
                {
                    "exact_snippets": "Willing to try to quit smoking within the next 3 months",
                    "criterion": "smoking cessation",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within the next 3 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Persons providing a valid phone number, a valid email address and/or a valid postal address.",
            "criterions": [
                {
                    "exact_snippets": "valid phone number",
                    "criterion": "phone number",
                    "requirements": [
                        {
                            "requirement_type": "validity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "valid email address",
                    "criterion": "email address",
                    "requirements": [
                        {
                            "requirement_type": "validity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "valid postal address",
                    "criterion": "postal address",
                    "requirements": [
                        {
                            "requirement_type": "validity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "Known hypersensitivity or allergy to contents of the e-liquid Participation in another study with investigational drug within the 30 days preceding the baseline visit and during the present study where interactions are to be expected",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity or allergy to contents of the e-liquid",
                    "criterion": "hypersensitivity or allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Participation in another study with investigational drug within the 30 days preceding the baseline visit",
                    "criterion": "participation in another study with investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "during the present study where interactions are to be expected",
                    "criterion": "participation in another study with investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women who are pregnant or breast feeding",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Intention to become pregnant during the course of the scheduled study intervention, i.e. within the first 6-months of the study",
            "criterions": [
                {
                    "exact_snippets": "Intention to become pregnant during the course of the scheduled study intervention",
                    "criterion": "intention to become pregnant",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "during the course of the scheduled study intervention"
                        }
                    ]
                },
                {
                    "exact_snippets": "within the first 6-months of the study",
                    "criterion": "intention to become pregnant",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within the first 6-months of the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Persons having used ENDS regularly in the 3 months preceding the baseline visit",
            "criterions": [
                {
                    "exact_snippets": "used ENDS regularly in the 3 months preceding the baseline visit",
                    "criterion": "ENDS usage",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "regularly"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "3 months preceding the baseline visit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Persons having used nicotine replacement therapy (NRT) or other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion within the 3 months preceding the baseline visit",
            "criterions": [
                {
                    "exact_snippets": "used nicotine replacement therapy (NRT)",
                    "criterion": "nicotine replacement therapy (NRT) usage",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the 3 months preceding the baseline visit"
                        }
                    ]
                },
                {
                    "exact_snippets": "used ... other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion",
                    "criterion": "medication usage for smoking cessation",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the 3 months preceding the baseline visit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Persons who cannot attend the 6- month follow-up visit for any reason",
            "criterions": [
                {
                    "exact_snippets": "cannot attend the 6- month follow-up visit",
                    "criterion": "ability to attend follow-up visit",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "6- month follow-up visit",
                    "criterion": "follow-up visit duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 6,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cannot understand instructions delivered in person or by phone, or otherwise unable to participate in study procedures",
            "criterions": [
                {
                    "exact_snippets": "Cannot understand instructions delivered in person or by phone",
                    "criterion": "understanding instructions",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "otherwise unable to participate in study procedures",
                    "criterion": "participation in study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}