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IQVIA™ Real-World Insights Bibliography
| Empagliflozin cardiovascular and renal effectiveness and safety compared to dipeptidyl peptidase-4 inhibitors across 11 countries in Europe and Asia: Results from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study |
| Author(s): Avraham Karasik (1), Stefanie Lanzinger (2,3), Elise Chia-Hui Tan (4), Daisuke Yabe (5,6,7 8), Dae Jung Kim (9), Wayne H-H Sheu (10), Cheli Melzer-Cohen (1), Reinhard W. Holl (2), Kyoung-Hwa Ha (9), Kamlesh Khunti (11), Francesco Zaccardi (11), Anuradhaa Subramanian (12), Krishnarajah Nirantharakumar (12,13,14), Thomas Nyström (15), Leo Niskanen (16), Majken Linnemann Jensen (17), Fabian Hoti (18), Riho Klement (19), Anouk Déruaz-Luyet (20), Moe H.Kyaw (21), Lisette Koeneman (22), Dorte Vistisen (23, 24) Bendix Carstensen (23), Sigrun Halvorsen (25), Gisle Langslet (26), Soulmaz Fazeli Farsani (20), Elisabetta Patorno (27), Júlio Núñez (28), EMPRISE Europe and Asia Study Group
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| Affiliations(s): "1
Maccabi Institute for Research and Innovation Center, Tel Aviv University, Tel Aviv, Israel
2
Institute for Epidemiology and Medical Biometry, ZIBMT, Ulm University, Ulm, Germany
3
German Centre for Diabetes Research (DZD), München-Neuherberg, Germany
4
Department of Health Service Administration, China Medical University, Taichung, Taiwan
5
Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kyoto, Japan
6
Department of Diabetes, Metabolism and Endocrinology/Department of Rheumatology and Clinical Immunology, Gifu University Graduate School of Medicine, Gifu, Japan
7
Center for Healthcare Information Technology, Tokai National Higher Education and Research System, Nagoya, Japan
8
Preemptive Food Research Center, Gifu University Institute for Advanced Study, Gifu, Japan
9
Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, South Korea
10
Division of Endocrinology and Metabolism, Taipei Veterans General Hospital, Taipei, Taiwan
11
Leicester Real World Evidence Unit, Leicester Diabetes Centre, University of Leicester, Leicester, UK
12
Institute of Applied Health Research, University of Birmingham, Birmingham, UK
13
Midlands Health Data Research UK, Birmingham, UK
14
DEMAND Hub, University of Birmingham, Birmingham, UK
15
Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Sweden
16
Päijät-Häme Joint Authority for Health and Wellbeing, Päijät-Häme Central Hospital, Lahti Finland and University of Eastern Finland, Kuopio, Finland
17
IQVIA Solutions Denmark A/S, Copenhagen, Denmark
18
IQVIA, Espoo, Finland
19
IQVIA, Tartu, Estonia
20
Boehringer Ingelheim International GmbH, Ingelheim, Germany
21
Boehringer Ingelheim International GmbH, US
22
Lilly Deutschland GmbH, Bad Homburg, Germany
23
Steno Diabetes Center Copenhagen, Herlev, Denmark
24
Department of Public Health, University of Copenhagen, Copenhagen, Denmark
25
Department of Cardiology, Oslo University Hospital Ullevål, and University of Oslo, Oslo, Norway
26
Lipid Clinic, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway
27
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts, USA
28
Department of Cardiology, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBER Cardiovascular, Valencia, Spain" |
Publication(s): "Diabetes & Metabolism. 2023 Jan; 101418; ISSN 1262-3636
Virtual Conference: American Diabetes Association, 25-29 June 2021 and EASD 27 September -01 October"
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| Document Type(s): Article, |
| Countries: Denmark, Finland, Germany, Norway, Spain, Sweden, UK, |
| Click here for the abstract |
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Cardiovascular disease, Diabetes, Drug safety, Drug Utlization Study,
2023 |
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English
Clinical setting: hospital, Clinical setting: Primary care, |
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| Empagliflozin is Associated with Lower Risk of Cardiovascular Events and All-Cause Mortality in Routine Care in East Asia: Results from the EMPRISE Study
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| Author(s): Dae Jung Kim (1), Wayne H-H Sheu (2), Wook-Jin Chung (3), Daisuke Yabe (4-7), Kyoung Hwa Ha (1), Masaomi Nangaku (8), Elise Chia-Hui Tan (9), Koichi Node (10), Atsutaka Yasui (11), Weiyu Lei (12), Sunwoo Lee (13), Laura Saarelainen (14), Anouk Deruaz-Luyet (15), Moe H. Kyaw (16) and Yutaka Seino (4,17), EMPRISE East Asia Study Group
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| Affiliations(s): "1
Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, South Korea
2
Division of Endocrinology and Metabolism, Taipei Veterans General Hospital, Taipei, Taiwan
3
Department of Cardiovascular Medicine, Gachon University Gil Medical Center, Incheon, South Korea
4
Kansai Electric Power Medical Research Institute, Kobe, Japan
5
Department of Diabetes, Metabolism and Endocrinology/Department of Rheumatology and Clinical Immunology, Gifu University Graduate School of Medicine, Gifu, Japan
6
Center for Healthcare Information Technology, Tokai National Higher Education and Research System, Nagoya, Japan
7
Division of Metabolism and Molecular Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
8
Division of Nephrology and Endocrinology, The University of Tokyo, Tokyo, Japan
9
National Research Institute of Chinese Medicine, Ministry of Health and Welfare, Taipei, Taiwan, and Institute of Hospital and Healthcare Administration, National Yang-Ming University, Taipei, Taiwan
10
Department of Cardiovascular Medicine, Saga University, Saga, Japan
11
Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan
12
Boehringer Ingelheim Taiwan Ltd., Taipei, Taiwan
13
Boehringer Ingelheim Korea Ltd, Seoul, Korea
14
IQVIA, Espoo, Finland
15
Boehringer Ingelheim International GmbH, Ingelheim, Germany
16
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA
17
Kansai Electric Power Hospital, Osaka, Japan
" |
Publication(s): "JDI journal
Virtual Conference: ACC, May 2021"
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| Document Type(s): Article, |
| Countries: Japan, Korea, Taiwan, |
| Click here for the abstract |
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Cardiovascular disease, Diabetes, Drug safety, Drug Utlization Study,
2023 |
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English
Clinical setting: hospital, Clinical setting: Primary care, Retrospective cohort analysis, |
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| The CLARION study: first report on safety findings in patients newly initiating treatment with cladribine tablets or fingolimod for multiple sclerosis
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| Author(s): Helmut Butzkueven, Jan Hillert, Merja Soilu-Hänninen, Tjalf Ziemssen, Jens
Kuhle, Stig Wergeland, Melinda Magyari, Joseph R. Berger, Nicholas Moore,
Aida Aydemir, Irene Bezemer & Meritxell Sabidó
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| Affiliations(s): "a Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia;
b The Alfred Hospital, Melbourne, VIC, Australia;
c Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden;
d Turku University Hospital Neurocenter and Division of Clinical Neurosciences, University of Turku, Turku, Finland;
e Center of Clinical Neuroscience, Department of Neurology, Dresden University of Technology, Dresden, Germany;
f Multiple Sclerosis Center and Research Center for Clinical Neuroimmunology and Neuroscience (RC2NB), Departments of Biomedicine and Clinical Research, University Hospital and University of Basel, Basel, Switzerland;
g Department of Neurology, University Hospital and University of Basel, Basel, Switzerland;
h Norwegian MS Registry and Biobank, Department of Neurology, Haukeland University Hospital, Bergen, Norway;
i Department of Clinical Medicine, University of Bergen, Bergen, Norway;
j Danish Multiple Sclerosis Center and the Danish Multiple Sclerosis Registry, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark;
k Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA;
l Bordeaux PharmacoEpi (BPE), Universit�e de Bordeaux, Bordeaux, France;
m EMD Serono Research & Development Institute, Inc, Billerica, MA, USA, an affiliate of Merck KGaA;
n Global Epidemiology, IQVIA, Amsterdam, The Netherlands;
o Merck Healthcare KGaA, Darmstadt, Germany"
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| Publication(s): |
| Document Type(s): Article, |
| Countries: Australia, Denmark, Finland, Germany, Norway, Sweden, Switzerland, Turkey, |
| Click here for the abstract |
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Comparative Effectiveness & Health Technology Assessment, Drug safety, Neurological disorders,
2023 |
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English
clinical setting: Secondary care, Epidemiological study, Population Based Study, |
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| The emerging role of real-world data in advanced breast cancer therapy: Recommendations for collaborative decision-making
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| Author(s): Paul Cottu 1, Scott David Ramsey 2, Oriol Solà-Morales 3, Patricia A Spears 4, Lockwood Taylor 5 |
| Affiliations(s): 1Department of Medical Oncology, Institut Curie, 26 Rue D'Ulm, 75005, Paris, France. Electronic address: paul.cottu@curie.fr.
2Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, M2-B232, Seattle, WA, 98155, USA. Electronic address: sramsey@fredhutch.org.
3Health Innovation Technology Transfer Foundation, Aragó 60, E-08015, Barcelona, Spain. Electronic address: osola@fhitt.org.
48605 Carolingian Court, Raleigh, NC, 27615, USA. Electronic address: paspears88@gmail.com.
5Epidemiology, Real World Solutions at IQVIA, 4820 Emperor Boulevard, Durham, NC, 27703, USA. Electronic address: lockwood.taylor@iqvia.com. |
Publication(s): Breast. 2021 Dec 22;61:118-122. doi: 10.1016/j.breast.2021.12.015.
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| Document Type(s): Article, |
| Countries: France, Italy, USA, |
| Click here for the abstract |
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Comparative Effectiveness & Health Technology Assessment, Drug safety, Oncology, Regulatory,
2022 |
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English
Review, |
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| The CLARION study design and status update: a long-term, registry-based study evaluating adverse events of special interest in patients with relapsing multiple sclerosis newly started on cladribine tablets |
| Author(s): Helmut Butzkueven 1 2, Nicholas Moore 3, Aida Aydemir 4, Jaak Sõnajalg 5, Irene Bezemer 6, Pasi Korhonen 7, Meritxell Sabidó 8, CLARION Study Group |
| Affiliations(s): 1Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Australia.
2The Alfred Hospital, Melbourne, Australia.
3Bordeaux PharmacoEpi (BPE), Université de Bordeaux, Bordeaux, France.
4Global Biostatistics, EMD Serono Research & Development Institute, Inc, Billerica, MA, USA (an affiliate of Merck KGaA).
5Global Database Studies, IQVIA, Tartu, Estonia.
6Global Epidemiology and Outcomes Research, IQVIA, Amsterdam, The Netherlands.
7IQVIA (former EPID Research), Espoo, Finland.
8Global Epidemiology, Merck Healthcare KGaA, Darmstadt, Germany. |
Publication(s): Current Medical Research and Opinion, DOI: 10.1080/03007995.2022.2059977
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| Document Type(s): Article, |
| Countries: Australia, Denmark, Finland, Germany, Norway, Sweden, Switzerland, Turkey, |
| Click here for the abstract |
C:
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Drug safety, Neurological disorders,
2022 |
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L:
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English
clinical setting: Secondary care, Epidemiological study, Observational study, Population Based Study, Retrospective database analysis, |
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| The longitudinal relationship between fatigue, depression, anxiety, disability, and adherence with cognitive status in patients with early multiple sclerosis treated with interferon beta-1a
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| Author(s): Hanne van Ballegooijen, Karin van der Hiele, Christian Enzinger, Gert de Voer, Leo H. Visser, on behalf of the CONFIDENCE Study Group |
| Affiliations(s): IQVIA Netherlands, Real World Evidence, Netherlands
b
Department of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, Netherlands
c
Medical University of Graz, Graz, Austria
d
Merck BV, Schiphol-Rijk, The Netherlands, an affiliate of Merck KGaA, Germany
e
St Elisabeth Tweesteden Hospital, Tilburg, the Netherlands |
Publication(s): eNeurologicalSci,
Volume 28,
2022,
100409,
ISSN 2405-6502,
https://doi.org/10.1016/j.ensci.2022.100409.
(https://www.sciencedirect.com/science/article/pii/S2405650222000181)
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| Document Type(s): Article, |
| Countries: Austria, Belgium, Netherlands , Slovakia, |
| Click here for the abstract |
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Drug safety, Drug Utlization Study, Neurological disorders,
2022 |
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English
Clinical setting: hospital, clinical setting: Secondary care, Epidemiological study, Population Based Study, Prospective study, |
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| Overview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018 |
| Author(s): Janet Sultana 1 2, Salvatore Crisafulli 3, Mariana Almas 4, Ippazio Cosimo Antonazzo 5 6, Esme Baan 7, Claudia Bartolini 6, Maria Paola Bertuccio 3, Fedele Bonifazi 8 9, Annalisa Capuano 10 11, Antonella Didio 8 9, Vera Ehrenstein 12, Mariagrazia Felisi 8 13, Carmen Ferrajolo 10 11, Andrea Fontana 14, Remy Francisca 7, Annie Fourrier-Reglat 15, Joan Fortuny 16, Rosa Gini 6, Giulia Hyeraci 6, Christel Hoeve 7, Christos Kontogiorgis 17, Valentina Isgrò 18, Panagiotis-Nikolaos Lalagkas 17, Luca L'Abbate 18, Deborah Layton 19, Annalisa Landi 8 9, Silvia Narduzzi 19, Leonardo Roque Pereira 20, Georgios Poulentzas 17, Concetta Rafaniello 10 11, Giuseppe Roberto 6, Giulia Scondotto 3, Liberata Sportiello 10 11, Maddalena Toma 8 9, Massoud Toussi 19, Katia Verhamme 7, Elisabetta Volpe 8 9, Gianluca Trifirò 18, |
| Affiliations(s): Pharmacy Department, Mater Dei Hospital, Msida, Malta.
2Exeter College of Medicine and Health, Exeter, UK.
3Department of Medicine, University of Verona, Verona, Italy.
4Real World Solutions Department, IQVIA, Lisbon, Portugal.
5Research Centre on Public Health (CESP), University of Milan-Bicocca, Milan, Italy.
6Agenzia Regionale di Sanità della Toscana, Florence, Italy.
7Department of Medical Informatics, Erasmus Medical Centre, Rotterdam, The Netherlands.
8TEDDY European Network of Excellence for Paediatric Clinical Research, Pavia, Italy.
9Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Bari, Italy.
10Department of Experimental Medicine, University of Campania "Vanvitelli", Naples, Italy.
11Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.
12Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
13CVBF Consorzio per Valutazioni Biologiche e Farmacologiche, Pavia, Italy.
14Unit of Biostatistics, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
15Univ. Bordeaux, INSERM, Bordeaux Population Health Research Center, Team of Pharmacoepidemiology, UMR 1219, Bordeaux, France.
16RTI Health Solutions, Barcelona, Spain.
17Democritus University of Thrace, Alexandroupolis, Greece.
18Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
19Data Science Hub, Real World Solutions, IQVIA, London, UK.
20Department of Datascience & Biostatistics, University Medical Center Utrecht, Utrecht, The Netherlands. |
Publication(s): Pharmacoepidemiol Drug Saf
. 2022 Jun;31(6):689-705. doi: 10.1002/pds.5413. Epub 2022 Feb 11.
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| Document Type(s): Article, |
| Countries: Denmark, France, Italy, Netherlands, Portugal, Spain, UK, |
| Click here for the abstract |
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Drug safety, Drug Utlization Study,
2022 |
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English
Database Study, Review, |
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| Insights from a review of publicly available information on Post Authorisation Safety Studies (PASS)
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| Author(s): Almas MF, Hoogendoorn WE, Sayeed S, Blackburn S, Bosco J, Parmenter L
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| Affiliations(s): IQVIA
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| Publication(s): |
| Document Type(s): Poster, |
| Countries: |
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Drug safety, Risk Management & REMS,
2022 |
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English
Review, |
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| Validation of safety outcomes in routinely collected data: lessons learned from a multinational post-approval safety study
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| Author(s): Arena PJ, Huang K, Löfling L, Bahmanyar S, Mo J, Schachterle SE, Nunes AP, Smits E, Juuti R, Hoti F, Korhonen P, Adelborg K, Sundbøll J, Rasmussen TR, Løkke A, Ehrenstein V.
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| Affiliations(s): "Pfizer Inc., New York, New York, United States of America.
Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, California, United States of America.
EPID Research (an IQVIA company), Espoo, Finland."
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Publication(s): Pharmacoepidemiol Drug Saf. 2022 Dec 10. doi: 10.1002/pds.5582
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| Document Type(s): Article, |
| Countries: Denmark, Finland, Netherlands , Sweden, USA, |
| Click here for the abstract |
C:
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Database Validity and methodology, Drug safety, Oncology,
2022 |
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English
Clinical setting: hospital, Clinical setting: Primary care, clinical setting: Secondary care, Retrospective database analysis, |
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| Ability of primary care health databases to assess medicinal products discussed by the European Union Pharmacovigilance Risk Assessment Committee |
| Author(s): Robert Flynn1,2,*, Karin Hedenmalm1, Tarita Murray-Thomas3, Alexandra Pacurariu1, Peter Arlett1, Hilary Shepherd3, Puja Myles3, Xavier Kurz1 |
| Affiliations(s): 1 Pharmacovigilance and Epidemiology Department, European Medicines Agency, Amsterdam, The
Netherlands
2 Medicines Monitoring Unit (MEMO), Division of Molecular and Clinical Medicine, University of Dundee,
Dundee, United Kingdom
3 Clinical Practice Research Datalink (CPRD), MHRA, London, United Kingdom |
Publication(s): First published: 18 January 2020 https://doi.org/10.1002/cpt.1775
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| Document Type(s): Abstract, Article, |
| Countries: France, Germany, UK, |
| Click here for the abstract |
C:
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Database Validity and methodology, Drug safety, Health policy,
2020 |
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English
Retrospective database analysis, |
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