Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-31 @ 7:13 PM
Study NCT ID:
NCT01624506
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2012-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Study of Anti-Reflux Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jdemarch@its.jnj.com', 'phone': '612-867-8727', 'title': 'Janet DeMarchi', 'organization': 'Ethicon'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Magnetic Sphincter Augmentation', 'description': 'Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System', 'otherNumAtRisk': 530, 'deathsNumAtRisk': 530, 'otherNumAffected': 98, 'seriousNumAtRisk': 530, 'deathsNumAffected': 1, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'Fundoplication', 'description': 'Patients treated with laparoscopic fundoplication', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 30, 'seriousNumAtRisk': 230, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 530, 'numEvents': 61, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 530, 'numEvents': 54, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Device erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 530, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 530, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gatric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 530, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 530, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 530, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 530, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 530, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of GERD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 530, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnetic Sphincter Augmentation', 'description': 'Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System'}, {'id': 'OG001', 'title': 'Fundoplication', 'description': 'Patients treated with laparoscopic fundoplication'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years post-surgery', 'description': 'Gastroesophageal Reflux Disease Health Related Quality of Life Outcomes (GERD-HRQL) Total scores range from 0-50 (min/max) 10 questions total, each rating 0-5 (min/max) Lower is better; higher is worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled subjects who completed the 3-year visit and responded to the Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL) questionnaire are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Magnetic Sphincter Augmentation', 'description': 'Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System'}, {'id': 'FG001', 'title': 'Fundoplication', 'description': 'Patients treated with laparoscopic fundoplication'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '530'}, {'groupId': 'FG001', 'numSubjects': '230'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '465'}, {'groupId': 'FG001', 'numSubjects': '213'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'LINX explants', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Not required'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '530', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '760', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Magnetic Sphincter Augmentation', 'description': 'Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System'}, {'id': 'BG001', 'title': 'Fundoplication', 'description': 'Patients treated with laparoscopic fundoplication'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '517', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '727', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '46.8', 'spread': '13.7', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '49.4', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data not available for remaining subjects'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '734', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '321', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '423', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not available for remaining subjects'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '530', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '760', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '530', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '760', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '530', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '760', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '530', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '760', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '431', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Years with Gastroesophageal Reflux Disease (GERD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '725', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '8.9', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '9.0', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data not available for remaining subjects'}, {'title': 'Years with Proton Pump Inhibitors (PPI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '517', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '720', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '5.8', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '6.0', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data not collected for remaining subjects'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 760}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-13', 'studyFirstSubmitDate': '2012-06-18', 'resultsFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2012-06-18', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-13', 'studyFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastroesophageal Reflux Disease Health Related Quality of Life Outcome (GERD-HRQL)', 'timeFrame': '3 years post-surgery', 'description': 'Gastroesophageal Reflux Disease Health Related Quality of Life Outcomes (GERD-HRQL) Total scores range from 0-50 (min/max) 10 questions total, each rating 0-5 (min/max) Lower is better; higher is worse'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastroesophageal Reflux Disease', 'Fundoplication', 'Magnetic Sphincter Augmentation', 'Proton Pump Inhibitors', 'GERD', 'PPI', 'MSA'], 'conditions': ['GERD', 'Gastroesophageal Reflux', 'Gastro Esophageal Reflux']}, 'referencesModule': {'references': [{'pmid': '32676727', 'type': 'DERIVED', 'citation': 'Bonavina L, Horbach T, Schoppmann SF, DeMarchi J. Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication. Surg Endosc. 2021 Jul;35(7):3449-3458. doi: 10.1007/s00464-020-07792-1. Epub 2020 Jul 16.'}, {'pmid': '25171881', 'type': 'DERIVED', 'citation': 'Riegler M, Schoppman SF, Bonavina L, Ashton D, Horbach T, Kemen M. Magnetic sphincter augmentation and fundoplication for GERD in clinical practice: one-year results of a multicenter, prospective observational study. Surg Endosc. 2015 May;29(5):1123-9. doi: 10.1007/s00464-014-3772-7. Epub 2014 Aug 30.'}]}, 'descriptionModule': {'briefSummary': 'The Anti-Reflux Surgical Study has been established to:\n\n* Collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and Fundoplication) in everyday clinical practice\n* Track the clinical course of patients from pre-operative assessment to three years post-surgery', 'detailedDescription': 'This study will track and monitor patients treated with either the magnetic sphincter augmentation or Fundoplication, making it the first Registry to collect data on both anti-reflux surgical options in the setting of everyday clinical experience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing antireflux surgery for the treatment of gastroesophageal reflux disease (GERD)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals treated with LINX Reflux Management System or Fundoplication\n* Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the Anti-Reflux Surgical Registry.\n* Individuals willing to complete questionnaires and comply with the three years of follow-up.\n\nExclusion Criteria:\n\n* Known circumstances that would make it unlikely for an individual to complete the three year follow-up (e.g. life expectancy \\<3 years)'}, 'identificationModule': {'nctId': 'NCT01624506', 'briefTitle': 'Observational Study of Anti-Reflux Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Torax Medical Incorporated'}, 'officialTitle': 'Observational Study of Anti-Reflux Surgery: Clinical Experience With the LINX Reflux Management System and Fundoplication', 'orgStudyIdInfo': {'id': '2776'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Magnetic Sphincter Augmentation', 'description': 'Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System'}, {'label': 'Fundoplication', 'description': 'Patients treated with laparoscopic fundoplication'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Herz Jesu Krankenhaus', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'MIC Klinik Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bottrop', 'country': 'Germany', 'facility': 'Knappschafts Krankenhaus Bottrop', 'geoPoint': {'lat': 51.52392, 'lon': 6.9285}}, {'city': 'Bremen', 'country': 'Germany', 'facility': 'Diako Bremen', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'city': 'Castrop-Rauxel', 'country': 'Germany', 'facility': 'Krankenhaus Castrop Rauxel', 'geoPoint': {'lat': 51.55657, 'lon': 7.31155}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Uniklinikum Koln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Forchheim', 'country': 'Germany', 'facility': 'Klinikum Forchheim', 'geoPoint': {'lat': 49.71754, 'lon': 11.05877}}, {'city': 'Herne', 'country': 'Germany', 'facility': 'Krankenhaus Herne', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'city': 'Kassel', 'country': 'Germany', 'facility': 'Marien Krankenhaus', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'city': 'München', 'country': 'Germany', 'facility': 'Arabella Klinik', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Neuruppin', 'country': 'Germany', 'facility': 'Ruppiner Kliniken', 'geoPoint': {'lat': 52.92815, 'lon': 12.80311}}, {'city': 'Schwabach', 'country': 'Germany', 'facility': 'Stadtkrankenhaus Schwabach', 'geoPoint': {'lat': 49.33047, 'lon': 11.02346}}, {'city': 'Telgte', 'country': 'Germany', 'facility': 'St. Rochus', 'geoPoint': {'lat': 51.97995, 'lon': 7.78293}}, {'city': 'Zweibrücken', 'country': 'Germany', 'facility': 'Ev. K Zweibrucken', 'geoPoint': {'lat': 49.24686, 'lon': 7.36977}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Policlinico San Donato', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Reflux Centre', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Epsom', 'country': 'United Kingdom', 'facility': 'Epsom and St. Helier Hospital', 'geoPoint': {'lat': 51.3305, 'lon': -0.27011}}, {'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Royal Devon & Exeter Hospital', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'city': 'Royal Tunbridge Wells', 'country': 'United Kingdom', 'facility': 'Spire Tunbridge Wells Hospital', 'geoPoint': {'lat': 51.13321, 'lon': 0.26256}}, {'city': 'Weymouth', 'country': 'United Kingdom', 'facility': 'Weymouth Hospital', 'geoPoint': {'lat': 50.61448, 'lon': -2.45991}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Torax Medical Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}