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COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI).
COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.
COMPLETE-2 STUDY OBJECTIVES
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiology-guided Non-Culprit-Lesion (NCL) PCI | Active Comparator | Patients randomized to this group will have their physiology assessment using RFR and/or FFR of all qualifying NCLs that were identified prior to randomization. Other validated non-hyperemic physiology ratios (eg. iFR) may only be used when RFR is not available. |
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| Angiography-guided NCL PCI | Other | Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiology-guided NCL PCI | Procedure | For RFR, PCI will be performed as per local practice for all lesions with RFR ≤0.89. For FFR, PCI will be performed as per local practice for all NCLs with FFR ≤0.80. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR | at study completion, a minimum of 2 years | |
| Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury. | at study completion, a minimum of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurrence of the composite of CV death or new MI. | at study completion, a minimum of 2 years | |
| Net clinical outcome: Time to first occurrence of the composite of CV death, new MI, clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury. |
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Inclusion Criteria:
Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:
Planned complete revascularization strategy for qualifying MI
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| COMPLETE-2 Project Office | Contact | (905) 521-2100 | complete-2@phri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Shamir Mehta, MD | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Recruiting | Los Angeles | California | 90095 | United States |
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| Angiography-guided NCL PCI | Procedure | PCI will be performed as per local practice |
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| at study completion, a minimum of 2 years |
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| Cardiovascular Research Institute of Kansas | Recruiting | Wichita | Kansas | 67226 | United States |
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| The Johns Hopkins University School of Medicine | Recruiting | Baltimore | Maryland | 21205 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI) | Recruiting | Coon Rapids | Minnesota | 55433 | United States |
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| RWJ Barnabas Health | Recruiting | Jersey City | New Jersey | 07302 | United States |
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| Bassett Medical Center | Recruiting | Cooperstown | New York | 13326 | United States |
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| VA New York Harbor HealthCare System | Recruiting | New York | New York | 10010 | United States |
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| NYU Grossman School of Medicine | Recruiting | New York | New York | 10016 | United States |
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| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
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| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| University of Virginia Medical Center | Recruiting | Charlottesville | Virginia | 22903 | United States |
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| Westmead Hospital | Recruiting | Westmead | New South Wales | Australia |
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| Klinik Floridsdorf | Recruiting | Vienna | Austria |
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| McGill University Health Centre (MUHC) | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| William Osler Health System | Recruiting | Brampton | Canada |
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| University of Alberta Hospital, Mazankowski Heart | Recruiting | Edmonton | Canada |
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| Hamilton Health Sciences | Recruiting | Hamilton | Canada |
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| Kingston Health Sciences Centre | Recruiting | Kingston | Canada |
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| St. Mary's General Hospital | Recruiting | Kitchener | Canada |
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| London Health Sciences Centre | Recruiting | London | Canada |
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| Centre Hospitalier de l'Universite de Montreal | Recruiting | Montreal | Canada |
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| Hopital du Sacre-Coeur de Montreal | Recruiting | Montreal | Canada |
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| Southlake Regional Health Centre | Recruiting | Newmarket | Canada |
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| Nova Scotia Health | Recruiting | Nova Scotia | Canada |
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| University of Ottawa Heart Institute | Recruiting | Ottawa | Canada |
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| Institut Universitaire de Cardiologie et de Pneumologie de Québec | Recruiting | Québec | Canada |
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| Regina General Hospital | Recruiting | Regina | Canada |
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| Royal University Hospital | Recruiting | Saskatoon | Canada |
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| Niagara Health | Recruiting | St. Catharines | Canada |
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| Newfoundland and Labrador Health Services | Recruiting | St. John's | Canada |
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| Thunder Bay Regional Health Sciences Centre | Recruiting | Thunder Bay | Canada |
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| St. Michael's Hospital (Unity Health Toronto) | Recruiting | Toronto | Canada |
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| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Canada |
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| Ciusss McQ - Chaur | Recruiting | Trois-Rivières | Canada |
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| St Paul's Hospital | Recruiting | Vancouver | Canada |
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| Vancouver General Hospital | Recruiting | Vancouver | Canada |
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| St. Boniface Hospital | Recruiting | Winnipeg | Canada |
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| St. Anne's University Hospital | Recruiting | Brno | Czechia |
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| Aalborg University Hospital | Recruiting | Aalborg | Denmark |
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| Aarhus University Hospital | Recruiting | Aarhus | Denmark |
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| Rigshospitalet - Copenhagen University Hospital | Recruiting | Copenhagen | Denmark |
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| Helsinki University Hospital | Recruiting | Helsinki | Finland |
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| TAYS Sydankeskus Oy | Recruiting | Tampere | Finland |
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| Turku University Hospital | Recruiting | Turku | Finland |
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| St. Vinzenz-Hospital | Recruiting | Cologne | Germany |
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| Helios Amper-Klinikum | Recruiting | Dachau | Germany |
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| Universitatsklinikum Frankfurt | Recruiting | Frankfurt | Germany |
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| Marienkrankenhaus | Recruiting | Hamburg | Germany |
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| Schoen Klink Hamburg | Recruiting | Hamburg | Germany |
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| University Heart & Vascular Center Hamburg | Recruiting | Hamburg | Germany |
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| WKK Heide | Recruiting | Heide | Germany |
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| Gottsegen National Cardiovascular Center | Recruiting | Budapest | Hungary |
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| University of Szeged | Recruiting | Szeged | Hungary |
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| Lisie Hospital | Recruiting | Ernākulam | Kerala | India |
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| Meditrina Hospital | Recruiting | Kollam | Kerala | India |
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| Caritas Hospital Trust | Recruiting | Kottayam | Kerala | India |
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| Apollo Rajshree Hospitals | Recruiting | Indore | Madhya Pradesh | India |
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| Rukmani Birla Hospital | Recruiting | Jaipur | Rajasthan | India |
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| Apollo Hospital | Recruiting | Chennai | Tamil Nadu | India |
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| The Madras Medical Mission | Recruiting | Chennai | Tamil Nadu | India |
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| Meenakshi Mission Hospital and Research Center | Recruiting | Madurai | Tamil Nadu | India |
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| Medicover Hospitals | Recruiting | Hyderabad | India |
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| Krishna Institute of Medical Sciences | Recruiting | Secunderabad | India |
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| Azienda USL Toscana Sud Est | Recruiting | Arezzo | Italy |
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| UOC Cardiologia - Ospedale Maggiore | Recruiting | Bologna | Italy |
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| Azienda Ospedaliero - Universitaria di Ferrara | Recruiting | Ferrara | Italy |
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| Misericordia Hospital | Recruiting | Grosseto | Italy |
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| Azienda USL-IRCCS di Reggio Emilia, Reggio | Recruiting | Reggio Emilia | Italy |
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| Sant Andrea Hospital - Sapienza University | Recruiting | Rome | Italy |
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| Sorlandet Hospital Arendal | Recruiting | Kristiansand | Arendal | Norway |
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| Oslo University Hospital Ulleval | Recruiting | Oslo | Norway |
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| Stavanger University Hospital | Recruiting | Stavanger | Norway |
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| University Hospital Tromso | Recruiting | Tromsø | Norway |
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| Provincial Specialized Hospital | Recruiting | Legnica | Lower Silesian Voivodeship | Poland |
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| Miedziowym Centrum Zdrowia S.A. w Lubinie | Recruiting | Lubin | Lower Silesian Voivodeship | Poland |
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| Medical University of Warsaw | Recruiting | Warsaw | Masovian Voivodeship | Poland |
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| Institute for Cardiovascular Diseases Dedinje | Recruiting | Belgrade | Serbia |
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| University Clinical Center of Serbia | Recruiting | Belgrade | Serbia |
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| Hospital Clinico San Carlos | Recruiting | Madrid | Spain |
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| Hospital Ramon y Cajal | Recruiting | Madrid | Spain |
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| Hospital Universitario de La Princesa | Recruiting | Madrid | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | Spain |
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| Hospital Virgen del Rocio | Recruiting | Seville | Spain |
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| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | Spain |
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| Hospital Clinico Universitario de Valladolid | Recruiting | Valladolid | Spain |
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| Karolinska University Hospital | Recruiting | Huddinge | Sweden |
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| Lanssjukhuset RYHOV | Recruiting | Jönköping | Sweden |
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| Karlstad Central Hospital | Recruiting | Karlstad | Sweden |
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| Skane University Hospital | Recruiting | Lund | Sweden |
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| Danderyd Hospital | Recruiting | Stockholm | Sweden |
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| Umeå University Hospital | Recruiting | Umeå | Sweden |
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| Uppsala University Hospital | Recruiting | Uppsala | Sweden |
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| East Kent Hospitals University NHS Foundation Trust | Recruiting | Ashford | United Kingdom |
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| Blackpool Teaching Hospitals | Recruiting | Blackpool | United Kingdom |
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| Ninewells Hospital | Recruiting | Dundee | United Kingdom |
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| Harefield Hospital | Recruiting | Harefield | United Kingdom |
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| Kettering General Hospital | Recruiting | Kettering | United Kingdom |
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| University Hospitals of Leicester | Recruiting | Leicester | United Kingdom |
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| Liverpool Heart and Chest Hospital | Recruiting | Liverpool | United Kingdom |
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| Barts Health NHS Trust | Recruiting | London | United Kingdom |
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| Imperial College Healthcare NHS Trust | Recruiting | London | United Kingdom |
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| Royal Free London NHS Foundation Trust | Recruiting | London | United Kingdom |
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| Manchester University NHS Foundation Trust | Recruiting | Manchester | United Kingdom |
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| The James Cook University Hospital | Recruiting | Middlesbrough | United Kingdom |
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| Freeman Hospital | Recruiting | Newcastle upon Tyne | United Kingdom |
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| Royal Berkshire Foundation NHS Trust | Recruiting | Reading | United Kingdom |
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| Sheffield Teaching Hospitals | Recruiting | Sheffield | United Kingdom |
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| East and North Hertfordshire NHS Trust | Recruiting | Stevenage | United Kingdom |
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| Royal Cornwall Hospitals NHS Trust | Recruiting | Truro | United Kingdom |
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| The Royal Wolverhampton NHS Trust | Recruiting | Wolverhampton | United Kingdom |
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| Worcestershire Acute Hospitals NHS Trust | Recruiting | Worcester | United Kingdom |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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