Atopic Dermatitis Clinical Trial
— APPLESOfficial title:
APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis
| Verified date | December 2019 |
| Source | LEO Pharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.
| Status | Terminated |
| Enrollment | 8071 |
| Est. completion date | January 31, 2019 |
| Est. primary completion date | January 31, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 16 Years |
| Eligibility |
Inclusion Criteria: - Subjects who first used Protopic® 0.03% or 0.1% before they were sixteen years of age and were treated for at least 6 weeks for the treatment of Atopic dermatitis may enroll into the study. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | LKH Feldkirch | Feldkirch | |
| Austria | Landesfrauen- und -kinderklinik | Linz | |
| Austria | Salzburger Landeskliniken | Salzburg | |
| Canada | Eastern Canada Cutaneous Research Association | Halifax | Nova Scotia |
| Canada | Mediprobe Research, Inc. | London | Ontario |
| Canada | Lynderm Research, Inc. | Markham | Ontario |
| Canada | NewLab Clinical Research, Inc. | St John's | Newfoundland and Labrador |
| Canada | Nexus Clinical Research | St Johns | Newfoundland and Labrador |
| Canada | Sudbury Skin Clinic | Sudbury | Ontario |
| Canada | Winnipeg Clinic | Winnipeg | Manitoba |
| France | Cabinet Medical | Amiens | |
| France | Hopital Pellegrin | Bordeaux | |
| France | Cabinet de Dermatologie - Boulogne | Boulogne | |
| France | Cabinet de Dermatologie - Boulogne-Sur-Mer | Boulogne | |
| France | Hopital Augustin Morvan | Brest Cedex 2 | |
| France | Cabinet de dermatologie - Cannes | Cannes | |
| France | Hopital Trousseau | Chambray Les Tours Cedex | |
| France | Polyclinique du Cotentin | Équeurdreville-Hainneville | |
| France | Centre Hospitalier | Le Mans Cedex | |
| France | Hopital Claude Huriez | Lille Cedex | |
| France | Cabinet de Dermatologie - Martigues | Martigues | |
| France | Cabinet Dermatologie | Nantes | |
| France | Hopital de l'Hotel Dieu | Nantes Cedex 1 | |
| France | Cabinet de Dermatologie | Nice | |
| France | Cabinet de Dermatologie - Paris | Paris | |
| France | Hospital Saint Louis | Paris Cedex 10 | |
| France | Hospital Necker | Paris Cedex 15 | |
| France | CHU La MILETRIE Service de Dermatologie | Poitiers Cedex | |
| France | HOPITAL CHARLES NICOLLE Service de Dermatologie | Rouen Cedex | |
| France | Hopital Nord | St. Priest En Jarez Cedex | |
| France | Cabinet de Dermatologie-Strasbourg | Strasbourg | |
| France | Cabinet de Dermatologie | Thann | |
| France | Hopital Larrey | Toulouse Cedex 9 | |
| France | Centre Hospitalier Service de Dermatologie | Troyes Cedex | |
| Germany | Licca Fachklinik f. aesthetisch- operative Dermatologie und Chirurgie | Augsburg | |
| Germany | Kinderarztpraxis | Bamberg | |
| Germany | Charite - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie u. Allergologie | Berlin | |
| Germany | Hautarztpraxis | Berlin | |
| Germany | Hautarztpraxis | Berlin | |
| Germany | Klinik fuer Kinder u. Jugendmedizin der Ruhr Universitaet Bochum im St.-Josef-Hospital | Bochum | |
| Germany | Universitaet Bonn Klinik und Poliklinik fuer Dermatologie | Bonn | |
| Germany | Hautarztpraxis | Bremen | |
| Germany | Hautarztpraxis | Bremen | |
| Germany | Dermatologisches Zentrum Buxtehude | Buxtehude | |
| Germany | Hautarztpraxis | Crimmitschau | |
| Germany | Hautarztpraxis | Dessau | |
| Germany | Arztpraxis fuer Hautkrankheiten | Dresden | |
| Germany | Hautarztpraxis | Dresden | |
| Germany | Klinik und Poliklinik f. Dermatologie Universitaetsklinikum Dresden | Dresden | |
| Germany | Hautklinik | Duesseldorf | |
| Germany | Heinrich-Heine-Universitaet Hautklinik | Duesseldorf | |
| Germany | Hautklinik des Universitaetsklinikums Erlangen | Erlangen | |
| Germany | Falker, Gernot, Hautarztpraxis | Frankenberg | |
| Germany | Universitaetsklinikum Klinische Forschung, Zentrum d. Dermatologie u. Venerologie | Frankfurt | |
| Germany | Derma-Study-Center-Friedrichshafen | Friedrichshafen | |
| Germany | Hautarztpraxis | Gelnhausen | |
| Germany | SRH Wald-Klinikum Gera GmbH | Gera | |
| Germany | Kath. Kinderkrankenhaus Wilhelmstift | Hamburg | |
| Germany | Klinische Forschung Hannover-Mitte GmbH | Hannover | |
| Germany | Brinkmann, Hautarztpraxis | Herborn | |
| Germany | Hautarztpraxis Sempell | Itzehoe | |
| Germany | Klinikum der Fr.-Schiller-Universitaet | Jena | |
| Germany | DermaKiel-Hautarztpraxis | Kiel | |
| Germany | Universitaet Hautklinik Kiel | Kiel | |
| Germany | Klinik fuer Dermatologie, Venerologie u. Allergologie | Leipzig | |
| Germany | Johannes-Gutenberg Universitaet | Mainz | |
| Germany | Praxis Dermatologie | Marburg | |
| Germany | Universitaetsklinikum Giessen+ Marburg Dermatolgie und Allergologie | Marburg | |
| Germany | Hautarztpraxis | Markkleeberg | |
| Germany | Kinder- und Jugendaertzin | Moenchengladbach | |
| Germany | Ludwig - Maximilians Universitaet, Klinik u. Poliklinik fuer Dermatologie u. Allergologie | Muenchen | |
| Germany | Facharzt f. Kinder-und Jugendmedizin | Muenster | |
| Germany | Proinnovera GmbH | Muenster | |
| Germany | Universitaetsklinikum Muenster, Klinik & Poliklinik Fuer Hautkrankheiten | Muenster | |
| Germany | Facharzt fuer Kinder-und Jugendmedizin | Ravensburg | |
| Germany | Hautarztpraxis | Riesa | |
| Germany | Richter - Fachaerztin fuer Kinder- und Jugendmedizin | Solingen | |
| Germany | Termeer, Christian | Stuttgart | |
| Germany | Universitaets-Hautklinik Tuebingen | Tuebingen | |
| Germany | Marienhospital Wesel Kinderklinik/Forschungsinstitut | Wesel | |
| Germany | Kinderarztpraxis | Wesseling | |
| Germany | Hautarztpraxis | Wusterwitz | |
| Ireland | South Infirmary | Cork | |
| Ireland | Our Lady's Hospital for Sick Children | Dublin | |
| Ireland | The Park Clinic | Dublin | |
| Netherlands | Academisch Medisch Centrum | Amsterdam | |
| Netherlands | Universitair Medisch Centrum Groningen | Groningen | |
| Netherlands | Universitair Medisch Centrum St. Radboud | Nijmegen | |
| Poland | Private Practice | Bydgoszcz | |
| Poland | Prywatna Praktyka Lekarska "Alergomed" | Bydgoszcz | |
| Poland | Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego w Bydgoszczy, Wojewodzka Przychodnia Specjalistyczna Dla Dzieci Poradnia ermatologiczna, Budynek "A" | Bydgoszcz | |
| Poland | Szpital Dzieciecy Specjalistyczny Z.O.Z. nad Matka i Dzieckiem | Gdansk | |
| Poland | Praktyka Lekarska | Gostynin | |
| Poland | SPZOZ Szpital Specjalistyczny im. S. Zeromskiego | Krakow | |
| Poland | Dermoklinika | Lodz | |
| Poland | NZOZ Centrum Alergologii | Lodz | |
| Poland | Alergovita | Lublin | |
| Poland | Indywidualna Specjalistyczna Praktyka Lekarska | Sierpc | |
| Poland | NZOZ Przychodnia Dermatologiczna DERMED s.c | Torun | |
| United Kingdom | Amersham Hospital, Department of Dermatology | Amersham | |
| United Kingdom | Birmingham Children's Hospital | Birmingham | |
| United Kingdom | Royal Bolton Hospitals Trust | Bolton | |
| United Kingdom | Addenbrooke's Hospital | Cambridge | |
| United Kingdom | Wales College of Medicine, Cardiff University, Heath Park | Cardiff | |
| United Kingdom | Ninewells Hospital and Medical School | Dundee | |
| United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | |
| United Kingdom | Harrogate & District Foundation NHS Trust Hospital | Harrogate | |
| United Kingdom | Leeds General Infirmary, Dept of Dermatology | Leeds | |
| United Kingdom | Site UK3007 | Leeds | |
| United Kingdom | Alder Hey Children's Hospital | Liverpool | |
| United Kingdom | Royal Free Hospital | London | |
| United Kingdom | Department of Pediatric Allergy and Immunology | Manchester | |
| United Kingdom | Chase Farm Hospital | Middlesex | |
| United Kingdom | George Eliot Hospital | Nuneaton | |
| United Kingdom | University of Manchester, Dermatology-Pharmacology Unit Hope Hospital | Salford | |
| United States | Paul S. Takiguchi- MD- Inc. | 'Aiea | Hawaii |
| United States | Wayne Fujita, M.D. - Private Practice | 'Aiea | Hawaii |
| United States | Davie Dermatology | Advance | North Carolina |
| United States | Shelby Dermatology | Alabaster | Alabama |
| United States | Georgia Pollens Clinical Research Centers, Inc | Albany | Georgia |
| United States | University of New Mexico | Albuquerque | New Mexico |
| United States | Pediatric Care Center of NE Alabama | Anniston | Alabama |
| United States | Academy of Clinical Research | Arlington | Texas |
| United States | Arlington Center for Dermatology | Arlington | Texas |
| United States | Glenn H. Fuchs, MD PC | Arlington | Virginia |
| United States | Emory University | Atlanta | Georgia |
| United States | Zoltan Trizna | Austin | Texas |
| United States | Johns Hopkins University, Division of Pediatric Dermatolgy | Baltimore | Maryland |
| United States | LA Dermatology Assoc LLC | Baton Rouge | Louisiana |
| United States | New York Dermatology, P.C. | Bayside | New York |
| United States | Haber Dermatology and Cosmetic Surgery, Inc | Beachwood | Ohio |
| United States | DermAssociates LTD | Belleville | Illinois |
| United States | Brookside Pediatrics | Bennington | Vermont |
| United States | Metro Pediatrics, P.C | Birmingham | Alabama |
| United States | Pediatric & Adult Asthma and Allergy, P.C. | Birmingham | Alabama |
| United States | Skin Wellness Center of Alabama | Birmingham | Alabama |
| United States | Southview Dermatology | Birmingham | Alabama |
| United States | Total Skin and Beauty Dermatology Center | Birmingham | Alabama |
| United States | Center for Dermatology | Boca Raton | Florida |
| United States | Dermatology Clinic of Idaho | Boise | Idaho |
| United States | Boston Children's Hospital | Boston | Massachusetts |
| United States | Angelos Koutsonikolis, MD, PA | Boynton Beach | Florida |
| United States | Joshua Berlin P.A. | Boynton Beach | Florida |
| United States | Morris Westfried, M.D. | Brooklyn | New York |
| United States | Robert S. Darr, MD, PC | Brooklyn | New York |
| United States | Alamance Skin Center | Burlington | North Carolina |
| United States | Coastal Allergy Care | Camarillo | California |
| United States | Dermatology, Inc. | Carmel | Indiana |
| United States | Shideler Clinical Research Center | Carmel | Indiana |
| United States | Central Wyoming Skin Clinic | Casper | Wyoming |
| United States | Dermatology Assoc of Northern Vineland | Centreville | Virginia |
| United States | Christie Clinic | Champaign | Illinois |
| United States | Dermatology and Laser Center of Charleston | Charleston | South Carolina |
| United States | The Asthma Institute PLLC | Chattanooga | Tennessee |
| United States | Cheraw Pediatrics, P.A. | Cheraw | South Carolina |
| United States | Children's Memorial Hospital | Chicago | Illinois |
| United States | Dermatology Research Associates, Inc. | Cincinnati | Ohio |
| United States | University Dermatology Consultants, Inc. | Cincinnati | Ohio |
| United States | Clarksburg Pediatrics, LLC | Clarksburg | Maryland |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Clinton Urgent Care | Clinton | Iowa |
| United States | Drs. Iacobelli & DiGregorio, PC | Clinton Township | Michigan |
| United States | Dermatology Group LLC | Columbia | South Carolina |
| United States | McClerklin Skin and Laser Center | Columbia | South Carolina |
| United States | Melissa Knuckles | Corbin | Kentucky |
| United States | Dermatology Consultants PC | Covington | Georgia |
| United States | Allergy Partners North Texas Research | Dallas | Texas |
| United States | Dermatology Treatment and Research Center, PA | Dallas | Texas |
| United States | Henry Ford Medical Center | Detroit | Michigan |
| United States | Dermatology Center for Children and Young Adults | Eagan | Minnesota |
| United States | Western Sky Medical Research | El Paso | Texas |
| United States | Pediatrx Clinic | Fayetteville | North Carolina |
| United States | North County Dermatology | Florissant | Missouri |
| United States | Hamzavi Dermatology | Fort Gratiot | Michigan |
| United States | Fort Lauderdale Dermatology & Cosmetic Skin Center | Fort Lauderdale | Florida |
| United States | Philadelphia Institute of Dermatology | Fort Washington | Pennsylvania |
| United States | North Texas Institute for Clinical Trials | Fort Worth | Texas |
| United States | University of N. Texas Health Science Center | Fort Worth | Texas |
| United States | Tien Nguyen | Fountain Valley | California |
| United States | Dermatology Center of Frisco | Frisco | Texas |
| United States | Family Allergy & Asthma Care | Gaithersburg | Maryland |
| United States | Garden City Dermatology, P.C. | Garden City | New York |
| United States | Cheryl D. Ackerman | Glen Ridge | New Jersey |
| United States | Callender Skin and Laser Center | Glenn Dale | Maryland |
| United States | Rivergate Dermatology Research Center | Goodlettsville | Tennessee |
| United States | Silverton Skin Institute | Grand Blanc | Michigan |
| United States | Pediatric Dermatology of North Texas PA | Grapevine | Texas |
| United States | Allergic Disease & Asthma Center | Greenville | South Carolina |
| United States | Stephen Schwartz | Harlingen | Texas |
| United States | Connecticut Children's Medical Center Dept of Dermatology | Hartford | Connecticut |
| United States | Bettencourt Skin Center | Henderson | Nevada |
| United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | Webster Dermatology, PA | Hockessin | Delaware |
| United States | Hollis Medisys | Hollis | New York |
| United States | Burke Pharmaceutical Research | Hot Springs | Arkansas |
| United States | Bear Creek Clinic, PA | Houston | Texas |
| United States | Heights Dermatology & Aesthetic Center | Houston | Texas |
| United States | Lone Star Children's Medical PLLC | Houston | Texas |
| United States | University of Texas - Houston | Houston | Texas |
| United States | West Houston Dermatology, PA | Houston | Texas |
| United States | Ruth A Yates | Huntsville | Alabama |
| United States | Southeast Idaho Family Practice | Idaho Falls | Idaho |
| United States | Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana |
| United States | Dermatology Associates, PC | Indianapolis | Indiana |
| United States | Dermatology and Laser Center | Irving | Texas |
| United States | Site US0048 | Irving | Texas |
| United States | Asthma & Allergy Center of North Jackson | Jackson | Mississippi |
| United States | Peace Children's Clinic | Jackson | Mississippi |
| United States | North Florida Dermatology Associates, P.A. | Jacksonville | Florida |
| United States | Clinical Partners, LLC | Johnston | Rhode Island |
| United States | Dermatology Associates of Kingsport, PC | Kingsport | Tennessee |
| United States | Allergy Associates, PA dba East Tennessee Center for Clinical Research | Knoxville | Tennessee |
| United States | Dermatology Associates of Knoxville, PC | Knoxville | Tennessee |
| United States | The Skin Wellness Center | Knoxville | Tennessee |
| United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | South Lincoln Dermatology Clinic | Lincoln | Nebraska |
| United States | Marvin S.Watsky | Lindenhurst | New York |
| United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
| United States | Allergy & Asthma Associates of NNM | Los Alamos | New Mexico |
| United States | Dermatology Research Associates | Los Angeles | California |
| United States | Lubbock Dermatology and Skin Cancer Center | Lubbock | Texas |
| United States | Southeastern Dermatology, PA | Lumberton | North Carolina |
| United States | Dermatologic Surgery Specialist Inc. | Macon | Georgia |
| United States | Univeristy of Wisconsin-Madison | Madison | Wisconsin |
| United States | Adult & Pediatric Dermatology | Marlborough | Massachusetts |
| United States | Piedmont Dermatology Center, PC | Martinsville | Virginia |
| United States | Rick Lin, D.O., MPH | McAllen | Texas |
| United States | Raleigh Group PC | Memphis | Tennessee |
| United States | Sheffield Pediatrics, PLLC | Memphis | Tennessee |
| United States | University of Miami Miller School of Medicine | Miami | Florida |
| United States | George V. Chandy MD SC | Milwaukee | Wisconsin |
| United States | University of Minnesota | Minneapolis | Minnesota |
| United States | Orange Dermatology Assoc, PC | Monroe | New York |
| United States | California Skin Institute | Mountain View | California |
| United States | The Dermatology Center | New Albany | Indiana |
| United States | Yale University School of Medicine | New Haven | Connecticut |
| United States | Kids First Prytania | New Orleans | Louisiana |
| United States | Columbia University Medical Center., Dept. of Medicine | New York | New York |
| United States | St. Luke's Roosevelt Hospital Center | New York | New York |
| United States | MedaPhase,Inc. | Newnan | Georgia |
| United States | Michael W. Simon, M.D. | Nicholasville | Kentucky |
| United States | Children's Hospital of the Kings Daughters | Norfolk | Virginia |
| United States | Virginia Clinical Research, Inc. | Norfolk | Virginia |
| United States | National Allergy and Asthma Research, LLC | North Charleston | South Carolina |
| United States | Andrea Trowers, MD | North Miami | Florida |
| United States | Tory Patrick Sullivan | North Miami Beach | Florida |
| United States | Allergy Associates of the Palm Beaches, PA | North Palm Beach | Florida |
| United States | East Penn Dermatology | North Wales | Pennsylvania |
| United States | Brian Lepley, D.O. | Oklahoma City | Oklahoma |
| United States | Family Health Center South | Oklahoma City | Oklahoma |
| United States | Oklahoma University Health Sciences Center | Oklahoma City | Oklahoma |
| United States | Skin Specialists PC | Omaha | Nebraska |
| United States | All Kids Pediatrics of Opelousas APMC | Opelousas | Louisiana |
| United States | Orlando Dermatology | Orlando | Florida |
| United States | Kansas City Dermatology, PA | Overland Park | Kansas |
| United States | Midwest Dermatology | Overland Park | Kansas |
| United States | Donna Zeide | Palm Beach Gardens | Florida |
| United States | Pasadena Dermatology Clinic | Pasadena | Texas |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | Paddington Testing Co, Inc. | Philadelphia | Pennsylvania |
| United States | Alliance Dermatology | Phoenix | Arizona |
| United States | Derma | Phoenix | Arizona |
| United States | Dermatology Center of Indiana P.C. | Plainfield | Indiana |
| United States | Waterman Dermatology | Plantation | Florida |
| United States | Kenneth M. Reed, MD | Quincy | Massachusetts |
| United States | Aistheta | Reno | Nevada |
| United States | CDLC | Ridgewood | New Jersey |
| United States | Helendale Dermatology & Medical Spa, LLC | Rochester | New York |
| United States | Palmetto Skin & Laser Center | Rock Hill | South Carolina |
| United States | FMC/OIC | Rocky Mount | North Carolina |
| United States | Hull Dermatology, P.A. | Rogers | Arkansas |
| United States | Capital Allergy & Respiratory Disease Center | Roseville | California |
| United States | Kosse Pediatrics | Saint Joseph | Missouri |
| United States | Dermatology Research Center | Salt Lake City | Utah |
| United States | Allergy and Immunology Clinic | San Diego | California |
| United States | Rady Children's Hospital San Diego | San Diego | California |
| United States | California Dermatology Care | San Ramon | California |
| United States | AeroAllergy Research Labs of Savannah, Inc. | Savannah | Georgia |
| United States | Asthma, Inc. | Seattle | Washington |
| United States | Dermatology Associates, PLLC | Seattle | Washington |
| United States | Healing Hands Family Medicine | Shreveport | Louisiana |
| United States | Highland Clinic | Shreveport | Louisiana |
| United States | Holliway Pediatric Clinic | Shreveport | Louisiana |
| United States | Wee Care Pediatrics & Kidmed Clinic | Shreveport | Louisiana |
| United States | Beverly Johnson, MD | Silver Spring | Maryland |
| United States | DermAssociates, PC | Silver Spring | Maryland |
| United States | Dimitri Dermatology | Slidell | Louisiana |
| United States | Marina I Peredo, MD | Smithtown | New York |
| United States | Medical Research Network | Spring | Texas |
| United States | SVC Dermatology PC | Sterling Heights | Michigan |
| United States | Southern Crescent Dermatology | Stockbridge | Georgia |
| United States | Derm Research Center of New York, Inc. | Stony Brook | New York |
| United States | Joseph D. Sutton, MD | Suffern | New York |
| United States | Dr.Robert A. Norman | Tampa | Florida |
| United States | Olympian Clinical Research | Tampa | Florida |
| United States | Kansas Medical Clinic, PA | Topeka | Kansas |
| United States | Somerset Skin Centre | Troy | Michigan |
| United States | OSU-CHS Houston Center Physicians | Tulsa | Oklahoma |
| United States | Dermatology Research Associates of Tyler | Tyler | Texas |
| United States | Stanley A. Newfield | Valley Stream | New York |
| United States | The Dermatology Group, PC | Verona | New Jersey |
| United States | Eastern Washington Dermatology | Walla Walla | Washington |
| United States | Grekin Skin Institute | Warren | Michigan |
| United States | Midwest Center for Dermatology and Cosmetic Surgery | Warren | Michigan |
| United States | Warren Dermatology & Allergy | Warren | Ohio |
| United States | Randall Dermatology | West Lafayette | Indiana |
| United States | Robert S. Berger | White Plains | Maryland |
| United States | Mid-Kansas Dermatology Clinic, PA | Wichita | Kansas |
| United States | Atlantic Skin & Cosmetic Surgery Group | Wilmington | Delaware |
| United States | Carolina Dermatology & Skin Cancer Surgery | Wilmington | North Carolina |
| United States | DermOne Dermatology Center, PA | Wilmington | North Carolina |
| United States | Knox Clinic Pediatrics, PLLC | Wilmington | North Carolina |
| United States | Wake Forest University School of Medicine | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| LEO Pharma |
United States, Austria, Canada, France, Germany, Ireland, Netherlands, Poland, United Kingdom,
D3T01.1J No increased risk of cancer in children using topical tacrolimus for atopic dermatitis: A 10-year prospective cohort study Prof. Dr. Regina Fölster-Holst - Germany 12 October 2019 11:00 - 11:15 EADV 2019
| Type | Measure | Description | Time frame | Safety issue |
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