Abstracts tagged "clinical trial"

Abstract Number: 0692 • ACR Convergence 2025
A Randomised Open Label Pilot Trial Comparing Mycophenolate Mofetil with no Immunosuppression in Limited Cutaneous Systemic Sclerosis (MINIMISE-Pilot)
Christopher Denton¹, Philip Yee², medha kanitkar³, Charlotte Clarke⁴, Saiam Ahmed⁴, Voon H. Ong³, Francesco Del Galdo⁵, John Pauling⁶, Marina Anderson⁷, Muditha Samaranayaka⁸, Michael Hughes⁹, Smita Bhat¹⁰, Bridget Griffiths¹¹, MAYA BUCH¹², David D'Cruz¹³, Ariane Herrick¹⁴, Madelon Vonk¹⁵, Nicholas Feemantle⁴ and Dehbi Hakim-Moulay⁴, ¹University College London, UK, London, United Kingdom, ²Division of Medicine, Centre for Rheumatology, University College London, London, England, United Kingdom, ³Division of Medicine, Centre for Rheumatology, University College London, London, United Kingdom, ⁴University College London, London, United Kingdom, ⁵University of Leeds, Leeds, United Kingdom, ⁶North Bristol NHS Trust, Bristol, United Kingdom, ⁷Lancaster University and NHS University Hospitals of Liverpool Group, Liverpool, United Kingdom, ⁸Salford Royal Hospital, Salford, United Kingdom, ⁹Division of Musculoskeletal and Dermatological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK, Manchester, England, United Kingdom, ¹⁰Ninewells Hospital Dundee, Dundee, Scotland, United Kingdom, ¹¹Ninewells Hospital Dundee, Newcastle, England, United Kingdom, ¹²UNIVERSITY OF MANCHESTER, MANCHESTER, United Kingdom, ¹³Kings College London, London, United Kingdom, ¹⁴The University of Manchester, UK, Aberdeen, United Kingdom, ¹⁵Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands
Background/Purpose: Mycophenolate mofetil (MMF) is recommended for skin in diffuse cutaneous (dc)SSc, and for lung fibrosis in SSc, but patients with limited cutaneous (lc)SSc are…
Abstract Number: 0563 • ACR Convergence 2025
Efficacy and Safety of Guselkumab in Patients with Active Psoriatic Arthritis and Inadequate Response and/or Intolerance to One Prior Tumor Necrosis Factor Inhibitor
Alexis Ogdie¹, Joseph F Merola², Philip J. Mease³, Christopher Ritchlin⁴, Jose U. Scher⁵, Kimberly Parnell Lafferty⁶, Daphne Chan⁷, Soumya Chakravarty⁸, Wayne Langholff⁹, Yanli Wang⁹, Olivia Choi, MD, PhD, FAAD⁷, Yevgeniy Krol¹⁰ and Alice Gottlieb¹¹, ¹Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Wilmington, DE, ²Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ³Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁴University of Rochester Medical Center, Canandaigua, NY, ⁵New York University School of Medicine, New York, NY, ⁶Johnson & Johnson, Dermatology, Horsham, PA, ⁷Johnson & Johnson, Horsham, PA, USA, Horsham, PA, ⁸Johnson & Johnson, Horsham, PA, USA; Drexel University College of Medicine, Philadelphia, PA, USA, Villanova, PA, ⁹Johnson & Johnson, Biostatistics, Spring House, PA, ¹⁰Johnson & Johnson, Horsham, PA, ¹¹Department of Dermatology, UT Southwestern Medical Center, Dallas, TX
Background/Purpose: Guselkumab (GUS), a fully human IL-23p19-subunit inhibitor, has demonstrated efficacy in significantly improving psoriatic arthritis (PsA) signs and symptoms with two dosing regimens: 100…
Abstract Number: 0545 • ACR Convergence 2025
Temporal trends in the phenotype and treatment outcomes in axial spondyloarthritis patients included in randomized clinical trials over 25 years: a systematic literature review and meta-regression analysis
Omar-Javier Calixto¹, Uta Kiltz², Brikena Lalazi³, Franziska Neinert³, Philipp Sewerin⁴ and Xenofon Baraliakos², ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Cellular and Molecular Immunology Group (InmuBo), Universidad El Bosque, Herne, Nordrhein-Westfalen, Germany, ²Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ³Rheumazentrum Ruhrgebiet, Herne, Germany, ⁴Rheumazentrum Ruhrgebiet Herne; Ruhr-Universität Bochum, Germany, Herne, Germany
Background/Purpose: The phenotypes of axial spondyloarthritis (axSpA) and clinical responses to placebo and study drugs in randomized controlled trials (RCTs) have changed over time. We…
Abstract Number: 0377 • ACR Convergence 2025
New efforts to incorporate patient-reported outcomes into clinical trials for lupus therapeutics
Patti Katz¹, Anca Askanase², Nandan Baruah³, Wen-Hung Chen⁴, Nicole Cooper⁵, Anna Fisch³, Lili Garrard⁶, Meenakshi Jolly⁷, Veronica Vargas Lupo⁸, Carla Menezes⁹, Judith Mills³, Hoang Nguyen¹⁰, Teodora Staeva⁵, Josephine Park¹¹ and Zahi Touma¹², ¹UCSF, San Rafael, CA, ²Columbia University Medical Center, New York, NY, ³Lupus Voices Council, Lupus Accelerating Breakthroughs Consortium, New York, ⁴GlaxoSmithKline, Philadelphia, PA, ⁵Lupus Research Alliance, New York, ⁶FDA, CDER, SIlver Spring, MD, ⁷Rush University, Chicago, ⁸Lupus Voices Council, Lupus Research Alliance, New York, NY, ⁹Lupus Therapeutics, New York, NY, ¹⁰Lupus Research Alliance, New York, NY, ¹¹EMDSerono, Boston, MA, ¹²University of Toronto, Toronto, ON, Canada
Background/Purpose: Lupus Accelerating Breakthroughs Consortium (Lupus ABC) was formed by the Lupus Research Alliance as a public private partnership of people living with lupus, investigators,…
Abstract Number: 2614 • ACR Convergence 2025
Impact of Vagus Nerve-Mediated Neuroimmune Modulation on structural joint damage using Gd-MRI RAMRIS imaging in Biologic-Experienced Patients with Rheumatoid Arthritis
Charles Peterfy, MD, PhD¹, John Tesser², Yaakov Levine³, Melissa Evangelista⁴, Vibeke Strand⁵, Michael Weinblatt⁶ and David Chernoff⁷, ¹Spire Sciences, Inc., Boca Raton, FL, ²Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ³SetPoint Medical, Valencia, CA, ⁴SetPoint Medical Corporation, Valencia, CA, ⁵Stanford University School of Medicine, Palo Alto CA, Portola Valley, CA, ⁶Brigham and Women's Hospital/ Harvard Medical School, Waban, MA, ⁷SetPoint Medical, Sausalito, CA
Background/Purpose: Previously reported results from RESET-RA (ClinicalTrials.gov, NCT04539964) showed neuroimmune modulation via electrical stimulation of the left vagus nerve using an implantable device to treat…
Abstract Number: 2374 • ACR Convergence 2025
Bimekizumab Efficacy And Safety Through 5 Years In Patients With Moderate To Severe Plaque Psoriasis In The US And Canada
Andrew Blauvelt¹, Saakshi Khattri², Phoebe Rich³, Ronald Vender⁴, Kenneth B. Gordon⁵, Balint Szilagyi⁶, Heather Herr⁷, Bertram Knapp⁶, Delphine Deherder⁸, Sarah Kavanagh⁹ and Kim Papp¹⁰, ¹Blauvelt Consulting, LLC, Portland, OR, ²The Mount Sinai Hospital, New York, NY, ³Oregon Dermatology and Research Center, Portland, OR, ⁴Dermatrials Research Inc., Hamilton, ON, Canada, ⁵Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, ⁶UCB, Monheim am Rhein, Germany, ⁷UCB, Smyrna, GA, ⁸UCB, Braine-l'Alleud, Belgium, ⁹UCB, Morrisville, NC, ¹⁰Probity Medical Research and Alliance Clinical Trials, Waterloo, and Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada
Background/Purpose: Given the chronic nature of psoriasis, and the loss of response observed with biologic therapies over time, it is crucial to establish the long-term…
Abstract Number: 2279 • ACR Convergence 2025
Long-Term Prevention of RA in high-risk individuals after a 6-Month Placebo-Controlled Intervention with Abatacept -The ARIAA Trial
Koray Tascilar¹, Mikkel Ostergaard², Verena Schoenau³, Uta Kiltz⁴, Xenofon Baraliakos⁴, David Kofler⁵, Martin Feuchtenberger⁶, Ulrike Steffen⁷, Mario Zaiss⁸, Michael Zaenker⁹, Reinhard Voll¹⁰, Cornelia. Glaser¹¹, Holger Bang¹², Eugen feist¹³, Gerd Burmester¹⁴, Kirsten Karberg¹⁵, Joachim Strunk¹⁶, Juan Cañete¹⁷, Esperanza Naredo¹⁸, Mária Filková¹⁹, Ladislav Šenolt¹⁹, Georg Schett²⁰ and Juergen Rech⁷, ¹Department of Medicine ³ - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and University Hospital Erlangen, Erlangen, Germany, ²Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark, and Copenhagen Center for Arthritis Research, Center for Rheumatology, Rigshospitalet, Glostrup, Denmark, ³- Department of Medicine ³ - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, Germany., Erlangen, Germany, ⁴Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁵University of Cologne, Cologne, Germany, ⁶MED | BAYERN OST GmbH, Fachbereich Rheumatologie, Burghausen, Germany, Burghausen, Bayern, Germany, ⁷Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Department of Internal Medicine ³ - Rheumatology and Immunology, Erlangen, Germany, Erlangen, Bayern, Germany, ⁸¹Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Department of Internal Medicine ³ - Rheumatology and Immunology, Erlangen, Germany, Erlangen, Bayern, Germany, ⁹Immanuel Klinikum Bernau , Herzzentrum Brandenburg, Abteilung Innere Medizin, Bernau, Germany, Berlin, Germany, ¹⁰University Medical Center Freiburg, Freiburg, Germany, ¹¹Department of Rheumatology and Clinical Immunology, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany, Freiburg, Baden-Wurttemberg, Germany, ¹²Orgentec, Mainz, Germany, ¹³Helios Department of Rheumatology, Vogelsang-Gommern, Germany, ¹⁴Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ¹⁵Praxis für Rheumatologie und Innere Medizin, Rheumatologie, Berlin, Germany, Berlin, Germany, ¹⁶Krankenhaus Porz am Rhein GmbH, Rheumaklinik, Köln (Porz), Germany, Köln-Porz, Germany, ¹⁷Rheumatology Department, Hospital Clínic and IDIBAPS, Barcelona, Spain, Barcelona, Spain, ¹⁸Department of Rheumatology and Joint and Bone Research Unit. Fundación Jiménez Díaz University Hospital and Health Research Institute FJD-UAM, Madrid, Spain, MADRID, Spain, ¹⁹Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ²⁰Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany, Erlangen, Germany
Background/Purpose: A 6-month intervention with abatacept in the ARIAA trial (EUDRA-CT 2014–000555–93) significantly retarded the development of RA compared to placebo in ACPA-positive individuals with…
Abstract Number: 1994 • ACR Convergence 2025
Pharmacokinetics of Ready-to-Use Pegloticase Formulation Compared to Standard Pegloticase Dosing: Data from the AGILE Study
Orrin Troum¹, John Botson², Afroz S. Mohammad³, Xiaoqing Yang⁴, Nathan Roe⁵, Supra Verma⁶ and Brian Lamoreaux⁷, ¹Providence Health Care/Doctor's of St John's (MDSJ) Santa Monica, CA, Santa Monica, CA, ²Orthopedic Physicians Alaska, Anchorage, AK, ³Amgen Inc, Deerfield, ⁴Amgen, Seattle, WA, ⁵Horizon Therapeutics, Boise, ID, ⁶Horizon Therapeutics, Newport Beach, CA, ⁷Amgen, Inc., Deerfield, IL
Background/Purpose: Pegloticase is approved for uncontrolled gout as 8-mg infusions admixed in 250 cc of normal saline over 120 minutes or more administered every 2…
Abstract Number: 1529 • ACR Convergence 2025
Updated Phase 1 Trial Data Assessing the Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of BMS-986353 (CC-97540), a CD19-directed Chimeric Antigen Receptor T Cell Therapy Using a Next-Generation Process for Severe, Refractory SLE
Georg Schett¹, David Simon², Margrit Wiesendanger³, Anca Askanase⁴, Vikas Majithia⁵, Neil Kramer⁶, Jacques Morel⁷, Philip J. Mease⁸, Ellen De Langhe⁹, Amit Saxena¹⁰, dominique Farge¹¹, Alain Lescoat¹², Alisha Desai¹³, Griff McTume¹⁴, Whitney Handy¹⁴, Sharmila Das¹³, Jerill Thorpe¹⁴, Alexis Melton¹⁴, Ashley Koegel¹⁴ and Emily Littlejohn¹⁵, ¹Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany, Erlangen, Germany, ²Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany; Deutsches Rheuma-Forschungszentrum Berlin, Berlin, Germany, Berlin, Germany, ³Icahn School of Medicine at Mount Sinai, New York, NY, ⁴Columbia University Medical Center, New York, NY, ⁵Mayo Clinic Hospital, Jacksonville, FL, ⁶Overlook Medical Center; Atlantic Medical Group, Atlantic Health System, Summit, NJ, ⁷CHU and University of Montpellier, Montpellier, France, ⁸Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁹University Hospitals Leuven, Leuven, Belgium, ¹⁰Division of Rheumatology, Department of Medicine, NYU Grossman School of Medicine, New York, NY, ¹¹Hôpital Saint-Louis, Paris, France, ¹²CHU Rennes University Hospital, Rennes, France, ¹³Bristol Myers Squibb, Princeton, NJ, ¹⁴Bristol Myers Squibb, Princeton, ¹⁵Cleveland Clinic, Cleveland, OH
Background/Purpose: BMS-986353 (CC-97540; CD19 NEX-T) is a CD19-directed chimeric antigen receptor (CAR) T cell therapy that expresses the same CAR as lisocabtagene maraleucel (liso-cel); it…
Abstract Number: 1364 • ACR Convergence 2025
Efficacy Of Ayurvedic Treatment Versus Placebo, Each In Combination With Methotrexate In Early RA Over 20 Weeks: An Exploratory Randomized Control Trial
Prativa Priyadarshani Sethi¹, Venkatesh Srinivasa Pai², Rajat Ranka², Avneet Kumar Gupta³, Ashish Baweja⁴, ritu sangwan⁵, Abhishek Rai⁶, Sryla Punjadath¹ and Nithya Maskani², ¹All India Institute of Medical Sciences, Rishikesh, Rishikesh, Uttarakhand, India, ²AIIMS RISHIKESH, Rishikesh, Uttarakhand, India, ³AIIMS RISHIKESH, Lucknow, Uttar Pradesh, India, ⁴Medanta, The Medicity, Gurugram, New Delhi, Delhi, India, ⁵AIIMS ,Rishikesh, Rishikesh, Uttarakhand, India, ⁶AIIMS ,RISHIKESH, Bhilai, Chhattisgarh, India
Background/Purpose: Early rheumatoid arthritis (RA) is a critical therapeutic window where prompt treatment targeting remission or low disease activity can significantly reduce long-term disability and…
Abstract Number: 0665 • ACR Convergence 2025
Infusion-Related Reactions (IRRs) and Hematologic Events Associated With Obinutuzumab in Lupus Nephritis: A Secondary Analysis of a Phase III Trial
Richard Furie¹, Teresa Baczkowska², Amit Saxena³, Imran Hassan⁴, Bongin Yoo⁵, Ben Lanza⁶, Himanshi Sehgal⁷, Frederic Boissard⁷, Jay Garg⁵, Thomas Schindler⁷, Elsa Martins⁷, William Pendergraft⁵ and Brad Rovin⁸, ¹Division of Rheumatology, Northwell Health, Great Neck, NY, ²Department of Transplantation Medicine, Nephrology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland, ³Division of Rheumatology, Department of Medicine, NYU Grossman School of Medicine, New York, NY, ⁴Hoffmann-La Roche Ltd, Mississauga, ON, Canada, ⁵Genentech, Inc., South San Francisco, CA, ⁶Roche Products Ltd, Welwyn Garden City, United Kingdom, ⁷F. Hoffmann-La Roche Ltd, Basel, Switzerland, ⁸The Ohio State University, Columbus, OH
Background/Purpose: The REGENCY (NCT04221477) trial demonstrated superior efficacy of obinutuzumab and standard therapy (OBI+ST) over placebo and ST (PBO+ST) in patients (pts) with active lupus…
Abstract Number: 0564 • ACR Convergence 2025
Improvements in Patient Reported Outcomes Through 24 Weeks of Guselkumab Treatment in Participants with Active Psoriatic Arthritis and Inadequate Response and/or Intolerance to One Prior Tumor Necrosis Factor Inhibitor
Alice Gottlieb¹, Joseph F Merola², Philip J. Mease³, Christopher Ritchlin⁴, Jose U. Scher⁵, Kimberly Parnell Lafferty⁶, Daphne Chan⁷, Soumya Chakravarty⁸, Wayne Langholff⁹, Yanli Wang⁹, Olivia Choi, MD, PhD, FAAD⁷, Yevgeniy Krol¹⁰ and Alexis Ogdie¹¹, ¹Department of Dermatology, UT Southwestern Medical Center, Dallas, TX, ²Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ³Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁴University of Rochester Medical Center, Canandaigua, NY, ⁵New York University School of Medicine, New York, NY, ⁶Johnson & Johnson, Dermatology, Horsham, PA, ⁷Johnson & Johnson, Horsham, PA, USA, Horsham, PA, ⁸Johnson & Johnson, Horsham, PA, USA; Drexel University College of Medicine, Philadelphia, PA, USA, Villanova, PA, ⁹Johnson & Johnson, Biostatistics, Spring House, PA, ¹⁰Johnson & Johnson, Horsham, PA, ¹¹University of Pennsylvania School of Medicine, Philadelphia, PA
Background/Purpose: Guselkumab (GUS), a fully human IL-23p19-subunit inhibitor, has demonstrated efficacy in significantly improving psoriatic arthritis (PsA) signs and symptoms in participants (pts) with active…
Abstract Number: 0523 • ACR Convergence 2025
SPECTREM: Guselkumab Significantly Improves Patient Reported Outcomes at Week 16 in Participants with Low Body Surface Area, Moderate Psoriasis with Special Sites Involvement
Jennifer Soung¹, Virginie Kelly², Marni Wiseman³, Adrian Rodriguez⁴, Theodore Alkousakis⁵, Olivia Choi⁵, Daphne Chan⁵, Katelyn Rowland⁵, Linda Hou⁶, Jenny Jeyarajah⁷, Nastaran Abbarin⁸, Elizabeth Skobelev⁵, Sancharitha Ramji⁵, James Krell⁹, Max Sauder¹⁰ and David Adam¹¹, ¹Southern California Dermatology, Inc, Santa Ana, CA, USA, Santa Ana, ²Saint-Louis Medical Clinic, Quebec, Canada, Quebec, Canada, ³SkinWise Dermatology, Manitoba, Canada, Manitoba, Canada, ⁴Nashville Skin Comprehensive Dermatology Center, Nashville, TN, USA, Nashville, TN, ⁵Johnson & Johnson, Horsham, PA, USA, Horsham, PA, ⁶Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Horsham, ⁷Johnson & Johnson, Horsham, PA, USA, Horsham, ⁸Janssen Inc, Toronto, ON, Canada, Toronto, Canada, ⁹Total Skin & Beauty Dermatology Center, Birmingham, AL, USA, Birmingham, ¹⁰Probity Medical Research, ON, Canada; University of Toronto, ON, Canada, Toronto, Canada, ¹¹CCA Medical Research, ON, Canada, Toronto, Canada
Background/Purpose: Even low body surface area (BSA) psoriasis can be extremely bothersome to patients and can have a significant impact on their lives just as…
Abstract Number: 0364 • ACR Convergence 2025
Group-Based Medical Mistrust and Logistical Factors Influencing Rheumatology Clinical Trial Enrollment: A Single-Center Cross-Sectional Survey
Andreina Martinez Paulino¹, Miles King², Danny Arias Diaz¹, Asma Cheema³ and Muznay Khawaja⁴, ¹Jersey City Medical Center, Jersey City, NJ, ²Albert Einstein College of Medicine, New York, NY, ³Montefiore Einstein , Wakefield Campus, Woodbridge Township, NJ, ⁴Jersey City Medical Center, Hoboken, NJ

Background/Purpose: Clinical trials are the cornerstone of evidence-based rheumatology, yet enrolling and retaining a representative patient cohort remains challenging. While underrepresentation of underserved minorities is…
Abstract Number: 2588 • ACR Convergence 2025
Nanoencapsulated Sirolimus plus Pegadricase (NASP) Demonstrates a Reduction in Gout Flares: Results from the Phase 3 DISSOLVE Studies
Angelo Gaffo¹, Herbert Baraf², Anand Patel³, Tuhina Neogi⁴, Rehan Azeem⁵, Wesley DeHaan⁶, Ben Peace⁷, Hugues Santin-Janin⁸, Bhavisha Desai⁹ and Naomi Schlesinger¹⁰, ¹Division of Rheumatology and Clinical Immunology, University of Alabama, Birmingham, AL, USA; Birmingham VA Medical Center, Birmingham, AL, USA, Birmingham, AL, ²The Center for Rheumatology and Bone Research, Rheumatology, Wheaton, Maryland, USA; Division of Rheumatology, The George Washington University, Washington, DC, ³Conquest Research, Winter Park, FL, USA, Winter Park, FL, ⁴Boston University School of Medicine, Boston, MA, ⁵Global MACD, Sobi Inc., Waltham, MA, ⁶Sobi, Inc, Waltham, MA, ⁷Statistical Science, Sobi, Stockholm, Sweden, ⁸Sobi, BASEL, Switzerland, ⁹Sobi, Glastonbury, CT, ¹⁰Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, UT, USA, Salt Lake City, UT
Background/Purpose: Urate-lowering therapy is recommended to lower serum urate (sUA) and for long-term prevention of gout flares (FitzGerald et al. Arthritis Care Res (Hoboken) 2020;…

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