Abstracts tagged "clinical trial"

Abstract Number: 1124 • ACR Convergence 2023
A Double-blind, Placebo-parallel Controlled Phase III Clinical Study of the Efficacy and Safety of Hemay005 Tablets in Patients with Moderate to Severe Chronic Plaque Psoriasis in China
Charles Jones¹, Jianzhong Zhang², Lihua Wang³, Xunyi Dai⁴, Huimin Wang⁵, Xiadong Bi⁶, Xinsuo Duan⁷, Zudong Meng⁸, Zhongwei Tian⁹, Aie Xu¹⁰, Bin Yang¹¹, Shuping Guo¹², Wei Li¹³, Qingchun Diao¹⁴, Hong Fang¹⁵, Yongjun Liu¹⁶, Juanli Fan¹⁷, Min Yan¹⁸, Sensen Lin¹⁹, Mingfei Zhu²⁰, xianjun Hu²⁰, Jinfeng Lin²⁰ and Mingye Bi²¹, ¹Hemay Pharmaceuticals, Tianjin, China, ²Peking University People’s Hospital, Beijing, China, ³Jinan Central Hospital, Jinan, China, ⁴Wuxi Second People's Hospital, Wuxi, China, ⁵Jinzhong First People's Hospital, Jinzhong, China, ⁶Nanyang First People's Hospital, Nanyang, China, ⁷Chengde Medical College Affiliated Hospital, Chengde, China, ⁸Shiyan City People's Hospital, Shiyan, China, ⁹The First Affiliated Hospital of Xinxiang Medical College, Weihui, China, ¹⁰Hangzhou Third People's Hospital, Hangzhou, China, ¹¹Skin Disease Hospital of Southern Medical University, Guangzhou, China, ¹²The First Hospital of Shanxi Medical University, Taiyuan, China, ¹³West China Hospital of Sichuan University, Chengdu, China, ¹⁴Chongqing Traditional Chinese Medicine Hospital, Chongqing, China, ¹⁵The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China, ¹⁶Qiqihar Traditional Chinese Medicine Hospital, Qiqihar, China, ¹⁷Yuncheng Central Hospital, Yuncheng, China, ¹⁸Shengli Oilfield Central Hospital, Dongying, China, ¹⁹Hangzhou Tigermed, Hangzhou, China, ²⁰Clinical Department, Tianjin Hemay Pharmaceutical Co., Ltd., Tianjin, China, ²¹Wuxi People's Hospital, Wuxi, China
Background/Purpose: Hemay005 is an orally active selective PDE4 inhibitor under clinical development for treating chronic inflammatory diseases. Hemay005 significantly inhibits the activation of T lymphocytes,…
Abstract Number: 1423 • ACR Convergence 2023
Impact of Upadacitinib on Enthesitis and Dactylitis by Location in Patients with Psoriatic Arthritis and an Inadequate Response to Biologic DMARDs from the SELECT-PsA 2 Trial
Laura Coates¹, Catherine Bakewell², Majed Khraishi³, Shirley Chen⁴, Tianming Gao⁴, Arathi Setty⁴, Heather Jones⁵, Sandra Ciecinski⁴ and Eduardo Mysler⁶, ¹University of Oxford, Oxford, United Kingdom, ²Intermountain Healthcare Medical Group, Salt Lake City, UT, ³Memorial University of Newfoundland, St. John's, NL, Canada, ⁴AbbVie, Inc., North Chicago, IL, ⁵AbbVie, Inc., Mettawa, IL, ⁶Organización Medica de Investigación, Buenos Aires, Argentina
Background/Purpose: Enthesitis and dactylitis are associated with reduced quality of life and greater impairment in daily activities. In the SELECT-PsA 2 phase 3 trial, the…
Abstract Number: 1517 • ACR Convergence 2023
Comparing Deep Neural Network to Modified Rodnan Skin Score in a Trial for Belumosudil in Systemic Sclerosis Patients
Baran Gunes¹, Lucy Duran Camacho¹, Shawn Cowper², Gauri Panse², Elizabeth Bundschuh³, Alyssa Williams⁴, Nicolas Page⁵, Mary Karns⁶, Kathleen Aren⁶, Niki Pradhan⁷, Elana Bernstein⁸, Sarah Fantus⁹, Elizabeth Volkmann¹⁰, Heather Bukiri¹⁰, Chase Correia¹¹, Francis Wilson¹, Seamus Mawe¹², J. Matthew Mahoney¹³, Monique Hinchcliff¹⁴ and Rui Wang¹⁵, ¹Yale University School of Medicine, New Haven, CT, ²Yale School of Medicine - Dermatopathology, New Haven, CT, ³Yale University School of Medicine, New York, NY, ⁴Yale University School of Medicine, Winchester, MA, ⁵Yale University School of Medicine, Salem, CT, ⁶Northwestern University Division of Rheumatology, Chicago, IL, ⁷Columbia University Irving Medical Center, New York, NY, ⁸Division of Rheumatology, Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, ⁹Kansas City Physician Partners- Center for Rheumatic Disease, Kansas City, MO, ¹⁰University of California Los Angeles, Los Angeles, CA, ¹¹Riverside Medical Group, Hampton, VA, ¹²The Jackson Laboratory, Bar Harbor, ME, ¹³Jackson Laboratory, Bar Harbor, ME, ¹⁴Yale School of Medicine, Westport, CT, ¹⁵Sanofi, Cambridge, MA
Background/Purpose: We previously published a proof-of-principle study demonstrating the potential utility of computer vision (Deep Neural Network/DNN) methods applied to stained skin biopsy sections from…
Abstract Number: 1992 • ACR Convergence 2023
Association Between Knee Osteoarthritis Pain and Concomitant Drug Use: A Post-hoc Analysis of Two Phase 3 Clinical Trials
Claire Miller¹, Matthew Baker², Peter Alexandersen³, Alejandro Mondragón¹, Ida Sofie Adrian¹, Morten Karsdal⁴, Jeppe Andersen⁵ and Asger Bihlet¹, ¹NBCD, Soeborg, Denmark, ²Stanford University, Menlo Park, CA, ³Sanos Clinics, Gandrup, Denmark, ⁴Nordic Bioscience, Herlev, Denmark, ⁵Sanos Group, Soeborg, Denmark
Background/Purpose: Patients with knee osteoarthritis are often overweight and suffer from comorbidities, which are frequently treated pharmacologically. Our understanding of the potential disease-modifying and/or symptom-modifying…
Abstract Number: 2249 • ACR Convergence 2023
Bimekizumab-Treated Patients with Active PsA Showed Sustained Improvement in Disease Symptoms Assessed by the PsA Impact of Disease (PsAID)-12 Questionnaire: 1-Year Results Reported from Two Phase 3 Studies
Dafna Gladman¹, Laura Coates², Maarten de Wit³, Alexis R Ogdie⁴, Ana-Maria Orbai⁵, Barbara Ink⁶, Vanessa Taieb⁷, Jérémy Lambert⁸ and Laure Gossec⁹, ¹Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Department of Medicine, University of Toronto, Toronto, ON, Canada, ²University of Oxford, Oxford, United Kingdom, ³Patient Research Partner, Stichting Tools, Amsterdam, Netherlands, ⁴University of Pennsylvania, Philadelphia, PA, ⁵Johns Hopkins University School of Medicine, Division of Rheumatology, Baltimore, MD, ⁶UCB Pharma, Slough, United Kingdom, ⁷UCB Pharma, Colombes, France, ⁸UCB Pharma, Irigny, France, ⁹Sorbonne Université and Pitié Salpêtrière Hospital, Paris, France
Background/Purpose: The PsA Impact of Disease‑12 (PsAID‑12) questionnaire is a patient (pt)-reported outcome measure assessing the impact of PsA on 12 physical, social, and psychological…
Abstract Number: 2490 • ACR Convergence 2023
Safety and Efficacy of Mycophenolate Mofetil in New-onset Systemic Lupus Erythematosus with High Titer of Anti-dsDNA Antibody and Without Major Organ Involvement: A Multicenter Randomized Controlled Trial
Junna Ye¹, Yijun You², Zhuochao Zhou², Jingyi Wu², Fan wang² and Chengde Yang², ¹Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China, ²Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Background/Purpose: Previous clinical trials of mycophenolate mofetil (MMF) in SLE were mainly focused on lupus nephritis (LN) (patients have been diagnosed with LN). In the…
Abstract Number: 010 • 2023 Pediatric Rheumatology Symposium
Remotely Delivered Psychological Intervention May Be Beneficial to Youth with Childhood-Onset Lupus: A Preliminary Investigation
Natoshia Cunningham¹, Michelle Adler², Ashley Danguecan³, Mallet Reid², Samantha Ely⁴, Mathew Reeves², Lawrence Ng³, Paris Moaf³, Sarah Mossad³, Tala El Tal³, Luana Flores Pereira³, Deborah Levy³, Linda Hiraki³, Jennifer Stinson³, Sarah Ahola Kohut³, Khalid Abulaban⁵, Elizabeth Kessler⁵, Stacy Allen⁵, Tamar Rubinstein⁶, Evin Rothschild⁶, Natalie Rosenwasser⁷, Kabita Nanda⁷, Susan Canny⁷, Emily Smitherman⁸, Livie Huie⁸, James Birmingham⁹, Allison Thompson¹⁰, Janel Thompson¹⁰, Miranda Moyer¹⁰, Emily Nguyen¹⁰, Angela Chapson¹⁰ and Andrea Knight³, ¹Michigan State University, Grand Rapids, MI, ²Michigan State University, East Lansing, ³The Hospital for Sick Children, Toronto, ON, Canada, ⁴Wayne State University, Michigan State University, Detroit, MI, ⁵Helen DeVos Children's Hospital, Grand Rapids, MI, ⁶Children's Hospital at Montefiore, New York, NY, ⁷Seattle Children's Hospital, Seattle, WA, ⁸University of Alabama at Birmingham, Birmingham, AL, ⁹Metro Health, Cleveland, ¹⁰Patient Co-Investigative Team
Background/Purpose: Childhood-onset systemic lupus erythematosus (cSLE) is associated with fatigue, pain, and depressive symptoms that adversely impact health-related quality of life. The Treatment and Education…
Abstract Number: 126 • 2023 Pediatric Rheumatology Symposium
Facilitating Peer-to-Peer Conversations Around Key Clinical Trial Recruitment Barriers in the Limit-JIA Trial Using Low-Fidelity Video Capture
Melanie Kohlheim¹, Eveline Wu², Laura Schanberg³, Vincent Del Gaizo¹, Catherine Lavallee⁴, Marc Natter⁵, Katie Clem⁶, Brian Shakley⁶ and Kevin Urban⁷, ¹CARRA, Washington, DC, ²UNC Chapel Hill, Chapel Hill, NC, ³Duke University Medical Center, Durham, NC, ⁴Virginia Tech Carilion School of Medicine, ROANOKE, VA, ⁵Boston Children's Hospital, Boston, MA, ⁶LIFT 1428, Llc, Ooltewah, TN, ⁷Business Coaching for Creatives, New York, NY
Background/Purpose: The LIMIT-JIA trial aims to study if early abatacept treatment can prevent disease extension in children with recent-onset, uncomplicated, and oligoarticular or limited JIA.…
Abstract Number: L06 • ACR Convergence 2022
Risk of Extended Major Adverse Cardiovascular Event Endpoints with Tofacitinib vs TNF Inhibitors in Patients with Rheumatoid Arthritis: A Post Hoc Analysis of a Phase 3b/4 Randomized Safety Study
Maya H. Buch¹, Deepak L. Bhatt², Christina Charles-Schoeman³, Jon T. Giles⁴, Ted R. Mikuls⁵, Gary Koch⁶, Steven Ytterberg⁷, Edward Nagy⁸, Hyejin Jo⁹, Kenneth Kwok⁹, Carol A. Connell¹⁰, Karim R. Masri¹¹ and Arne Yndestad¹², ¹Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Division of Cardiovascular Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, ³Division of Rheumatology, Department of Medicine, University of California, Los Angeles, CA, ⁴Division of Rheumatology, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, ⁵Division of Rheumatology, University of Nebraska Medical Center and VA Nebraska-Western Iowa Health Care System, Omaha, NE, ⁶Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁷Division of Rheumatology, Mayo Clinic, Rochester, MN, ⁸Pfizer Ltd, Tadworth, Surrey, United Kingdom, ⁹Pfizer Inc, New York, NY, ¹⁰Pfizer Inc, Groton, CT, ¹¹Pfizer Inc, Collegeville, PA, ¹²Pfizer Inc, Oslo, Norway
Background/Purpose: ORAL Surveillance (NCT02092467; a post-authorization safety study of tofacitinib 5 and 10 mg twice daily [BID] vs TNF inhibitors [TNFi]) found higher risk of…
Abstract Number: L07 • ACR Convergence 2022
Telitacicept, a Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), in Systemic Lupus Erythematosus (SLE): Results of a Phase 3 Study
Di Wu¹, Jing Li¹, Dong Xu¹, Li Wang¹, Jianmin Fang², Dan Ross³ and Fengchun Zhang⁴, ¹Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China, Beijing, China, ²Shanghai Tongji Hospital, Tongji University, Shanghai 200065, China School of Life Science and Technology, Tongji University, Shanghai 200092, China, Shanghai, China, ³RemeGen Co., San Diego, CA, ⁴Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China; Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China, Beijing, China
Background/Purpose: Telitacicept is a novel recombinant fusion protein constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor…
Abstract Number: L14 • ACR Convergence 2022
Bimekizumab Maintains Improvements in Efficacy Endpoints and Has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studies
Xenofon Baraliakos¹, Atul Deodhar², Désirée van der Heijde³, Marina Magrey⁴, Walter Maksymowych⁵, Tetsuya Tomita⁶, Huji Xu⁷, Marga Oortgiesen⁸, Ute Massow⁹, Carmen Fleurinck¹⁰, Alicia M Ellis⁸, Tom Vaux¹¹, Julie Shepherd-Smith¹¹, Alexander Marten⁹ and Lianne S Gensler¹², ¹Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, ²Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ³Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁴Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, US, Richfield, OH, ⁵Department of Medicine, University of Alberta, Edmonton, AB, Canada, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka City, Osaka City, Osaka, Japan, ⁷Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China (People's Republic), ⁸UCB Pharma, Morrisvile, NC, ⁹UCB Pharma, Monheim am Rhein, Nordrhein-Westfalen, Germany, ¹⁰UCB Pharma, Brussels, Brussels Hoofdstedelijk Gewest, Belgium, ¹¹UCB Pharma, Slough, United Kingdom, ¹²Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL‑17A. In the phase 3 BE MOBILE 1 and 2…
Abstract Number: L02 • ACR Convergence 2022
Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from a Phase 3, Randomized, Placebo-Controlled, Active Reference Study
Christopher Ritchlin¹, Laura Coates², Iain McInnes³, Philip J. Mease⁴, Joseph Merola⁵, Yoshiya Tanaka⁶, Akihiko Asahina⁷, Laure Gossec⁸, Alice Gottlieb⁹, Diamant Thaci¹⁰, Barbara Ink¹¹, Deepak Assudani¹¹, Rajan Bajracharya¹¹, Vish Shende¹¹, Jason Coarse¹² and Robert Landewé¹³, ¹University of Rochester Medical Center, Rochester, NY, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, United Kingdom, ³College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom, ⁴Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ⁵Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, ⁶University of Occupational and Environmental Health Japan, Kitakyushu, Japan, ⁷Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan, ⁸Sorbonne Universités, UPMC Univ Paris 06, GRC-UPMC 08 (EEMOIS); AP-HP, Hôpital Pitié Salpêtrière, Rheumatology Department, Paris, France, Paris, France, ⁹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ¹⁰Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, ¹¹UCB Pharma, Slough, United Kingdom, ¹²UCB Pharma, Raleigh, NC, ¹³Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, and Zuyderland MC, Heerlen, Netherlands
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. BKZ treatment has demonstrated superior efficacy in joints and…
Abstract Number: 0281 • ACR Convergence 2022
Clinical Outcomes of Filgotinib in Patients with RA Aged ≥65 Years: A Post Hoc Subgroup Analysis of Phase 2 and 3 Clinical Trials and Ongoing Long-Term Extensions
Maya Buch¹, BERNARD COMBE², Jose A Gomez-Puerta³, Roberto Felice Caporali⁴, jacques-eric gottenberg⁵, Paul Van Hoek⁶, Vijay Rajendran⁷, Pieter-Jan Stiers⁶, Katrien Van Beneden⁶, Daniel Aletaha⁸, Gerd Burmester⁹, Rene Westhovens¹⁰ and Yoshiya Tanaka¹¹, ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Montpellier University, Montpellier, France, ³Hospital Clínic de Barcelona, Barcelona, Spain, ⁴University of Milan, Milano, Italy, ⁵Strasbourg University Hospital, Strasbourg, France, ⁶Galapagos NV, Mechelen, Belgium, ⁷Galapagos NV, Gent, Belgium, ⁸Medical University Vienna, Wien, Austria, ⁹Charité University Medicine Berlin, Berlin, Germany, ¹⁰University Hospitals Leuven, Leuven, Belgium, ¹¹University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan
Background/Purpose: Filgotinib (FIL) is a Janus kinase 1 preferential inhibitor approved for the treatment of moderate to severe active RA.1 It was previously reported that…
Abstract Number: 0359 • ACR Convergence 2022
Attainment of Remission with Anifrolumab: A Post Hoc Analysis of Pooled TULIP-1 and TULIP-2 Datasets
Ronald Van Vollenhoven¹, Eric F. Morand², Richard A. Furie³, Ian N. Bruce⁴, Gabriel Abreu⁵, Raj Tummala⁶, Hussein Al-Mossawi⁷ and Catharina Lindholm⁸, ¹Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, University of Amsterdam, Amsterdam, Netherlands, ²Monash University, Melbourne, Australia, ³Northwell Health, Great Neck, NY, ⁴The University of Manchester, Manchester, United Kingdom, ⁵AstraZeneca, Mölndal, Sweden, ⁶AstraZeneca, Gaithersburg, MD, ⁷AstraZeneca, Cambridge, United Kingdom, ⁸AstraZeneca, Gothenburg, Sweden
Background/Purpose: In patients with SLE, achieving remission is a treat-to-target goal. Remission is associated with lower rates of hospitalization and damage accrual and better quality…
Abstract Number: 0525 • ACR Convergence 2022
Recovery of Renal Function Among ANCA-Associated Vasculitis Patients with Baseline eGFR ≤20 in the Avacopan ADVOCATE Trial
David Jayne¹, Peter Merkel², Frank Cortazar³, John Niles⁴ and Pirow Bekker⁵, ¹University of Cambridge, Cambridge, United Kingdom, ²U of Pennsylvania, Philadelphia, PA, ³St. Peter's Hospital, Albany, NY, ⁴Harvard, Boston, MA, ⁵ChemoCentryx, San Juan Capistrano, CA
Background/Purpose: In the 330-patient ADVOCATE trial of avacopan for the treatment of ANCA-associated vasculitis, in which 81% of patients with ANCA-associated vasculitis had renal involvement,…

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Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. Academic institutions, private organizations and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part a scientific presentation or presentation of additional new information that will be available at the time of the meeting) is under embargo until Saturday, November 11, 2023.

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