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{  "metadata": {    "Designs": ["Randomized Controlled Trial"],    "Types": [],    "BriefSummary": "To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4\n weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The\n dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a\n calibrator.",    "Abstract": "To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4\n weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The\n dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a\n calibrator.",    "Acronym": null,    "ArticleId": "Qy3gwKWSoaWRmbmFEQA",    "Authors": null,    "CochraneID": null,    "Confidential": false,    "CorporateAuthor": null,    "Country": "Bulgaria, Canada, Hungary, Israel, Norway, Slovakia, United Kingdom, United States",    "CustomData": null,    "DatabaseType": "ClinicalTrials.gov",    "DOI": null,    "EmbaseAccessionNumber": null,    "Emtree": null,    "ErrataText": null,    "FullTextURL": null,    "Institution": null,    "ISSN": null,    "Issue": null,    "JournalTitle": null,    "MedlineID": null,    "MeSH": "Hypercholesterolemia|Antibodies, Monoclonal",    "Pages": null,    "ParentChildStatus": null,    "ParentID": null,    "PublicationDate": "March 21, 2017",    "PublicationYear": 2017,    "PubType": null,    "ReferenceStudy": null,    "SecondarySourceID": null,    "Source": "Regeneron Pharmaceuticals",    "SourceReferenceId": "NCT01926782",    "TaStudyDesign": "Randomized",    "Title": "A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia",    "TrialOutcome": null,    "Volume": null,    "Id": 179246831,    "Created": "2020-04-10T14:48:20.4384957Z",    "VersionNo": 2,    "ExtractData": null,    "Digitized": true,    "IsRapidExtract": false,    "IsUploaded": false  },  "design": "Randomized Controlled Trial",  "conditions": [{ "label": "Cholesterol Total Increased", "id": "SUE_c" }],  "phase": 3,  "name": "NCT01926782",  "trialIds": ["NCT01926782"],  "acronyms": [],  "outcomeCount": 156,  "id": 179246831,  "groups": [    {      "Id": "4r",      "RefId": "B5|O2~Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin",      "OriginalName": "Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin",      "N": 37,      "age": 59.3,      "ageSD": 11.3,      "male": 37.83783783783784,      "Interventions": [{ "termIds": [["SUBYEL", "SUB_Oc"], ["SUNUVb"]] }],      "analyzeAs": "Alirocumab",      "analyzableScore": 1.0717734625362931,      "matchingScore": 0    },    {      "Id": "zB",      "RefId": "B6|O3~Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin",      "OriginalName": "Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin",      "N": 146,      "age": 59.2,      "ageSD": 10.8,      "male": 45.205479452054796,      "Interventions": [{ "termIds": [["SUBYEL", "SUB_Oc"]] }],      "analyzeAs": "Statins",      "analyzableScore": 1.0717734625362931,      "matchingScore": 0    },    {      "Id": "3!",      "RefId": "B4|O1~Placebo Q2W Without Concomitant Statin",      "OriginalName": "Placebo Q2W Without Concomitant Statin",      "N": 73,      "age": 59.4,      "ageSD": 10.2,      "male": 54.794520547945204,      "Interventions": [{ "termIds": [["SUGeLS"], ["SUBYEL", "SUB_Oc"]] }],      "analyzeAs": "Control",      "analyzableScore": 1.2020833333333334,      "matchingScore": 0    },    {      "Id": "tv",      "RefId": "E3",      "OriginalName": "Alirocumab 300 mg Q4W/Up 150 mg Q2W",      "Interventions": [{ "termIds": [["SUCO54", "SUNUVb"]] }]    },    {      "Id": "jt",      "RefId": "B3|O3~Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin",      "OriginalName": "Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin",      "N": 312,      "age": 61.6,      "ageSD": 10,      "male": 60.8974358974359,      "Interventions": [{ "termIds": [["SUBYEL", "SUB_Oc"]] }]    },    {      "Id": "5!",      "RefId": "E2",      "OriginalName": "Alirocumab 75 mg Q2W/Up 150 mg Q2W",      "Interventions": [{ "termIds": [["SUNUVb"]] }]    },    {      "Id": "4E",      "RefId": "B2|O2~Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin",      "OriginalName": "Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin",      "N": 78,      "age": 60.7,      "ageSD": 9.1,      "male": 65.38461538461539,      "Interventions": [{ "termIds": [["SUBYEL", "SUB_Oc"], ["SUNUVb"]] }]    },    {      "Id": "i4",      "Interventions": [        {          "Id": "Ya",          "Name": 178613599,          "Treatments": [{ "Id": "((", "Phase": "k)" }],          "Type": "Drug",          "termIds": [["SUGeLS"], ["SUNUVb"]],          "terms": [["Placebo"], ["Alirocumab"]]        },        {          "Id": "o)",          "Name": 2159990,          "Treatments": [{ "Id": "1$", "Phase": "k)" }],          "Type": "Drug",          "termIds": [["SUBYEL"]],          "terms": [["Statins"]]        }      ],      "RefId": "E1|Placebo Q2W",      "OriginalName": "Placebo Q2W"    },    {      "Id": "Ls",      "RefId": "B1|O1~Placebo Q2W With Concomitant Statin",      "OriginalName": "Placebo Q2W With Concomitant Statin",      "N": 157,      "age": 61.6,      "ageSD": 9.7,      "male": 64.3312101910828,      "Interventions": [{ "termIds": [["SUGeLS"], ["SUBYEL", "SUB_Oc"]] }]    }  ],  "hasDocData": true,  "hasRapidExtract": false,  "N": 803,  "queryScore": 1.4868329805051381,  "matchingScore": 7.960635921410255,  "score": 22.084654254966498,  "outcomes": [    {      "id": "179246387",      "type": "Change",      "unit": "%",      "termIds": [["SUF0R", "SUBskP"]],      "quantifiers": [],      "name": "Calculated LDL-C in Not Receiving Concomitant Statin Therapy - On-Treatment Analysis",      "cells": [        {          "number": -0.4,          "unit": "%",          "group": "3!",          "varType": "se",          "N": 70,          "se": 2,          "sd": 16.73        },        {          "number": -54.6,          "unit": "%",          "group": "4r",          "varType": "se",          "N": 37,          "se": 2.8,          "sd": 17.03        },        {          "number": -59.4,          "unit": "%",          "group": "zB",          "varType": "se",          "N": 141,          "se": 1.4,          "sd": 16.62        }      ],      "time": {        "Id": 67122072,        "Low": { "Value": "Baseline" },        "High": { "Number": 24, "Unit": "wk" },        "Type": "Total",        "days": 168,        "description": "24wk"      },      "score": 2.08,      "matchingTerm": "SUF0R",      "suggestedPositive": false,      "sourceUnit": "%"    },    {      "id": "179246389",      "type": "Change",      "unit": "%",      "termIds": [["SUF0R", "SUBskP"]],      "quantifiers": [],      "name": "Calculated LDL-C in Receiving Concomitant Statin Therapy - On-Treatment Analysis",      "cells": [        {          "number": -0.3,          "unit": "%",          "group": "Ls",          "varType": "se",          "N": 151,          "se": 2.1,          "sd": 25.81        },        {          "number": -55.1,          "unit": "%",          "group": "4E",          "varType": "se",          "N": 75,          "se": 3,          "sd": 25.98        },        {          "number": -62.3,          "unit": "%",          "group": "jt",          "varType": "se",          "N": 302,          "se": 1.5,          "sd": 26.07        }      ],      "time": {        "Id": 67122072,        "Low": { "Value": "Baseline" },        "High": { "Number": 24, "Unit": "wk" },        "Type": "Total",        "days": 168,        "description": "24wk"      },      "score": 2.08,      "matchingTerm": "SUF0R",      "suggestedPositive": false,      "sourceUnit": "%"    },    {      "id": "179246393",      "type": "Change",      "unit": "%",      "termIds": [["SUF0R", "SUBskP"]],      "quantifiers": [],      "name": "Calculated LDL-C in Not Receiving Concomitant Statin Therapy - On-Treatment Analysis",      "cells": [        {          "number": -0.5,          "unit": "%",          "group": "3!",          "varType": "se",          "N": 70,          "se": 2,          "sd": 16.73        },        {          "number": -53.9,          "unit": "%",          "group": "4r",          "varType": "se",          "N": 37,          "se": 2.7,          "sd": 16.42        },        {          "number": -60,          "unit": "%",          "group": "zB",          "varType": "se",          "N": 141,          "se": 1.4,          "sd": 16.62        }      ],      "time": {        "Id": 67122069,        "Low": { "Value": "Baseline" },        "High": { "Number": 12, "Unit": "wk" },        "Type": "Total",        "days": 84,        "description": "12wk"      },      "score": 2.08,      "matchingTerm": "SUF0R",      "suggestedPositive": false,      "sourceUnit": "%"    },    {      "id": "179246394",      "type": "Change",      "unit": "%",      "termIds": [["SUF0R", "SUBskP"]],      "quantifiers": [],      "name": "Calculated LDL-C in Receiving Concomitant Statin Therapy - On-Treatment Analysis",      "cells": [        {          "number": 1.4,          "unit": "%",          "group": "Ls",          "varType": "se",          "N": 151,          "se": 1.9,          "sd": 23.35        },        {          "number": -47.3,          "unit": "%",          "group": "4E",          "varType": "se",          "N": 75,          "se": 2.8,          "sd": 24.25        },        {          "number": -58,          "unit": "%",          "group": "jt",          "varType": "se",          "N": 302,          "se": 1.4,          "sd": 24.33        }      ],      "time": {        "Id": 67122069,        "Low": { "Value": "Baseline" },        "High": { "Number": 12, "Unit": "wk" },        "Type": "Total",        "days": 84,        "description": "12wk"      },      "score": 2.08,      "matchingTerm": "SUF0R",      "suggestedPositive": false,      "sourceUnit": "%"    }  ],  "characteristics": [    {      "id": "179246354",      "type": "Binary",      "isCharacteristic": true,      "termIds": [["SUE_c", "SUCbN", "SUyJj"]],      "quantifiers": [],      "name": "Patients not having adequate control of their hypercholesterolemia based on their individual level of CVD risk",      "cells": [],      "number": 100    }  ],  "outcomesScore": 18.97947630112307}