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NCT06686615Active, not recruiting

A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Effectiveness and Safety of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: an Observational Study

Source: ClinicalTrials.gov · Last updated 30 Sept 2026

Brief summary (registry, in English)

Data on the real-world use and effectiveness and safety of bempedoic acid combined with both a statin and ezetimibe in clinical practice is limited. There is an increased focus on using combination therapy to lower LDL-C.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
2000 (estimated)
First submitted
11 Nov 2024
Start date
12 Feb 2025
Primary completion date
31 Jul 2027
Lead sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
NCT number
NCT06686615

What you commit to

  • Study type: Observational
  • Planned participants: 2000
  • From 12 Feb 2025 to the primary completion date, 31 Jul 2027
  • 163 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have received PCSK9i monoclonal antibody treatment in the last 3 months before the start of the triple therapy exposure
  • Patients who have ever received PCSK9i-siRNA treatment

Who the study is looking for

  • Written informed consent to participate
  • At least 18 years of age
  • High and very high risk patients as assessed by the physician suffering from documented primary hypercholesterolemia or mixed dyslipidemia at start of bempedoic acid treatment
  • Patients treated with:
    • bempedoic acid added to ezetimibe and rosuvastatin or atorvastatin,
    • bempedoic acid plus ezetimibe added to rosuvastatin or atorvastatin,
    • bempedoic acid plus atorvastatin or rosuvastatin added to ezetimibe
    • initiation of bempedoic acid, ezetimibe, and atorvastatin or rosuvastatin simultaneously
    • 6\) Initiation of triple therapy within a maximum of four weeks prior to inclusion 7) An untreated LDL-C value must be available within 5 years prior to the start of the triple therapy. Untreated means that the LDL-C value is not influenced by any lipid lowering therapy at the time of blood collection. Time window for not being treated as specified in the protocol.
    • 8\) No contraindications exist according to the SmPC of bempedoic acid, the respective statin and ezetimibe as per physicians' assessment 9) No concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is possible) 10) Life expectancy \> 1 -year

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (163)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Innere Medizin
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Braunau am InnAustriaUnknown status
Innere Medizin 1
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FeldkirchAustriaUnknown status
Uniklinik Graz, Endokrinologie und Diabetes
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GrazAustriaUnknown status
Uniklinik Graz, Kardiologie
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GrazAustriaUnknown status
Innere Medizin 3 - Kardiologie
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InnsbruckAustriaUnknown status
Klinikum Wels-Grieskirchen GmbH+B18
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Kepler Universitätsklinikum Gmb+AustriaUnknown status
Innere Medizin
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KlagenfurtAustriaUnknown status
Innere Medizin
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LinzAustriaUnknown status
Kardiologie-Urfahr Dr. Hönig & Dr. Gammer & Dr. Buchmayr
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LinzAustriaUnknown status
Kepler Universitätsklinikum GmbH Klinik für Innere Medizin 1 - Kardiologie und Internistische Intensivmedizin
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LinzAustriaUnknown status
Ordination
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MattersburgAustriaUnknown status
Landesklinikum Mistelbach - Gänserndorf
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MistelbachAustriaUnknown status
Ordination Dr. med. univ. Evelyn Fließer-Görzer
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Saint Stefan Bei GrazAustriaUnknown status
Praxis Gesundheitszentrum Moos 15 (Praxis Prof. Lichtenauer)
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SalzburgAustriaUnknown status
DOZ (Dialyse- und Ordinationszentrum) Privatklinik Wehrle-Diakonissen
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SalzburgAustriaUnknown status
Herzzentrum 18
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ViennaAustriaUnknown status
Ordination Univ.-Prof. Dr. Kurt Huber
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ViennaAustriaUnknown status
Klinik Landstrasse, Kardiologie
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ViennaAustriaUnknown status
Clinic Hietzing
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ViennaAustriaUnknown status
Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung c/o Abteilung für Kardiologie, Klinik Floridsdorf
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ViennaAustriaUnknown status
Akh Wien
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ViennaAustriaUnknown status
Meduni Wien, Endokrinologie und Diabetes
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ViennaAustriaUnknown status
Meduni Wien, Kardiologie
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ViennaAustriaUnknown status
Zentrum für klinische Studien Dr Hanusch Gmbh
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ViennaAustriaUnknown status
AZORG
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AalstBelgiumUnknown status
UZA (Antwerp University Hospital)
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AntwerpBelgiumUnknown status
Epicure Hornu
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BoussuBelgiumUnknown status
A.Z. KLINA Brasschaat
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BrasschaatBelgiumUnknown status
Algemeen Ziekenhuis Sint-Jan Oostende
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BrugesBelgiumUnknown status
CHU Brugman
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BrusselsBelgiumUnknown status
UZ Brussel
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BrusselsBelgiumUnknown status
GHDC Charleroi - Site Hôpital Saint-Joseph
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CharleroiBelgiumUnknown status
CHU Charleroi Hopital civil Marie-Curie
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CharleroiBelgiumUnknown status
Z.O.L - Campus St. Jan
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GenkBelgiumUnknown status
AZ Sint-Lucas
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GhentBelgiumUnknown status
UZ Gent
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GhentBelgiumUnknown status
CHR Huy
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HuyBelgiumUnknown status
AZ Groeninge, Kortrijk
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KortrijkBelgiumUnknown status
Pôle hospitalier Jolimont
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La LouvrièreBelgiumUnknown status
Jan Yperman Ziekenhuis
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LeperBelgiumUnknown status
UZ Leuven
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LeuvenBelgiumUnknown status
CHR Citadelle de Liège
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LiègeBelgiumUnknown status
CHU Mons Ambroise Paré
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MonsBelgiumUnknown status
AZ Delta
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RoeselareBelgiumUnknown status
az Glorieux
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RonseBelgiumUnknown status
CHU UCL Mont-Godinne
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YvoirBelgiumUnknown status
Praxis für Kardiologie Aachen
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AachenGermanyUnknown status
Klinikum Ahaus
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AhausGermanyUnknown status
Praxis W. Almohamed
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AlsfedGermanyUnknown status
Zentrum für Klinische Studien Bad Homburg
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Bad HomburgGermanyUnknown status
Lipidambulanz Charite Campus Virchow
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BerlinGermanyUnknown status
Dialysezentrum Hellersdorf Mitte
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BerlinGermanyUnknown status
MediClin Reha-Zentrum Spreewald
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BurgGermanyUnknown status
Kardiologische Gemeinschaftspraxis Flemmingstr.
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ChemnitzGermanyUnknown status
Klinik Detmold
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DetmoldGermanyUnknown status
Praxis Dr. Methfessel
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DresdenGermanyUnknown status
Cardiologicum Dresden
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DresdenGermanyUnknown status
Herz- und Gefäßmedizin Goslar
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GoslarGermanyUnknown status
ndgl.; viele Kombinationstherapien
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GräfenhainichenGermanyUnknown status
Praxis
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GreizGermanyUnknown status
Kardiologie am Tibarg
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HamburgGermanyUnknown status
Jessa Ziekenhuis
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HasseltGermanyUnknown status
Uni-Klinik Heidelberg
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HeidelbergGermanyUnknown status
HPK Heidelberger Praxisklinik
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HeidelbergGermanyUnknown status
Kardiopraxis
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KaiserslauternGermanyUnknown status
GK Mittelrhein
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KoblenzGermanyUnknown status
Klinikum Konstanz
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KonstanzGermanyUnknown status
Universitatsklinikum Leipzig
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LeipzigGermanyUnknown status
DRK Krankenhaus Lichtenstein Gemeinnützige GmbH
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LichtensteinGermanyUnknown status
Cardio Centrum Ludwigsburg
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LudwigsburgGermanyUnknown status
Kardiopraxis
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MainzGermanyUnknown status
Kardiologische Praxis Markkleeberg
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MarkkleebergGermanyUnknown status
Kardiologie Gem. Praxis Dres Reiff/Linse/Haj-Yehia/Specking
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MoersGermanyUnknown status
Praxis Dr. Norbert Schön
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Mühldorf A. InnGermanyUnknown status
Kardiologische Gemeinschaftpraxis Papenburg
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PapenburgGermanyUnknown status
Kardiologische Gemeinschaftspraxis Papenburg
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PapenburgGermanyUnknown status
Hausärztlich- Kardiologisches MVZ "Am Felsenkeller" GmbH
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PirnaGermanyUnknown status
Kardiologische Gemeinschaftspraxis am Park Sanssouci
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PotsdamGermanyUnknown status
Lipidambulanz Uniklinikum Regensburg
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RegensburgGermanyUnknown status
Parkkardiologie, kard. Gemeinschaftspraxis
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Stanhsdorf B. BerlinGermanyUnknown status
Diabetologische Schwerpunktpraxis
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TrierGermanyUnknown status
BBT Trier
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TrierGermanyUnknown status
Herzklinik
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UlmGermanyUnknown status
Dialysezentrum Hofaue
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WuppertalGermanyUnknown status
H. Univers. De Albacete
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AlbaceteSpainUnknown status
H. General de Elche
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AlicanteSpainUnknown status
Hospital General Universitario Dr. Balmis
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AlicanteSpainUnknown status
Hospital Universitario de San Juan
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AlicanteSpainUnknown status
Hospital Universitario de Cruces
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BarakaldoSpainUnknown status
Hospital Universitario De Burgos
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BurgosSpainUnknown status
H. Univ. Puerta del Mar
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CadizSpainUnknown status
H. Punta de Europa
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CadizSpainUnknown status
Hospital Universitario Puerto Real
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CadizSpainUnknown status
Sierrallana Hospital
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CantabriaSpainUnknown status
H. Univ. Reina Sofía
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CórdobaSpainUnknown status
Hospital Universitario de Donostia
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Donostia / San SebastianSpainUnknown status
H. Univ. De Cabueñes
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GijónSpainUnknown status
H. Virgen de las Nieves
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GranadaSpainUnknown status
H Juan Ramón Jiménez
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HuelvaSpainUnknown status
Hospital Universitario Médico-Quirúrgico de Jaén
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JaénSpainUnknown status
Hospital Universitario de Gran Canarias Dr. Negrín
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Las Palmas de GCSpainUnknown status
Hospital de León
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LeónSpainUnknown status
Hospital San Pedro
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LogroñoSpainUnknown status
Hospital Serranía de Ronda
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MálagaSpainUnknown status
H. Virgen de la Victoria
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MálagaSpainUnknown status
H. Costa del Sol
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Marbella (Málaga)SpainUnknown status
H. Virgen de la Arrixaca
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MurciaSpainUnknown status
Hospital General Universitario Reina Sofía
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MurciaSpainUnknown status
Hospital Universitario Central De Asturias
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OviedoSpainUnknown status
Hospital Universitario Son Llatzer
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Palma de MallorcaSpainUnknown status
Hospital Universitario de Navarra
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PamplonaSpainUnknown status
Clínica Universidad de navarra
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PamplonaSpainUnknown status
Hospital Universitario de Canarias
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Santa Cruz de TenerifeSpainUnknown status
Hospital de Segovia
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SegoviaSpainUnknown status
Hospital General Universitario de Toledo
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ToledoSpainUnknown status
H. Clínico Univ. de Valencia
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ValenciaSpainUnknown status
Consorcio Hospital General Univ de Valencia
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ValenciaSpainUnknown status
Hospital La Fe
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ValenciaSpainUnknown status
Hospital Universitario de Álava
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Vitoria-GasteizSpainUnknown status
Hospital Clinico Universitaro Lozano Blesa
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ZaragozaSpainUnknown status
Ente Ecclesiastico "Miulli"
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Acquaviva delle FontiItalyUnknown status
INRCA
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AnconaItalyUnknown status
AO Moscati
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AvellinoItalyUnknown status
Osp. "San Paolo"
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BariItalyUnknown status
Ospedale di Bolzano
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BolzanoItalyUnknown status
Spedali Civili di Brescia
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BresciaItalyUnknown status
Osp. santo spirito
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Casale MonferratoItalyUnknown status
Ospedale Sant'Anna e san Sebastiano
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CasertaItalyUnknown status
Policlinnico Mater Domini
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CatanzaroItalyUnknown status
Osp. SS Annunziata
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ChietiItalyUnknown status
PO Nuovo Umberti I
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EnnaItalyUnknown status
Osp. Sant'Anna di Cona
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FerraraItalyUnknown status
Policlinico "Riuniti"
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FoggiaItalyUnknown status
Policlinico San Martino
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GenovaItalyUnknown status
Osp della Misericordia
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GrossetoItalyUnknown status
Osp. "Vito Fazzi"
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LecceItalyUnknown status
Ospedale Mater Salutis
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LegnagnoItalyUnknown status
Spedali Riuniti
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LivornoItalyUnknown status
Ospedale di Mantova
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MantuaItalyUnknown status
Policlinico G. Martino
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MessinaItalyUnknown status
IRCCS Galeazzi-Sant'Ambrogio
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MilanItalyUnknown status
IRCCS Monzino
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MilanItalyUnknown status
Policlinico Modena
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ModenaItalyUnknown status
Policlinico Federico II
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NaplesItalyUnknown status
AO Cardarelli
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NaplesItalyUnknown status
AOU Vanvitelli, I Policlinico
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NaplesItalyUnknown status
Policlinico P. Giaccone
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PalermoItalyUnknown status
ICS Maugeri
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PaviItalyUnknown status
S. Maria della Misericordia
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PerugiaItalyUnknown status
Presidio Ospedaliero
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PescaraItalyUnknown status
Ospedale PederzoliItlit
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PeschieraItalyUnknown status
Cisanello
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PisaItalyUnknown status
Osp. Santa Maria delle Croci
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RavennaItalyUnknown status
Osp infermi di rivoli
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RivoliItalyUnknown status
Ospedale Pertini
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RomaItalyUnknown status
Policlinico Tor Vergata
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RomaItalyUnknown status
Ospedale Sant'Andrea
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RomaItalyUnknown status
Policlinico Umberto I
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RomeItalyUnknown status
Molinette Università to
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TorinoItalyUnknown status
Ospedale Mauriziano
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TorinoItalyUnknown status
Osp. di Cattinara
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TriesteItalyUnknown status
Ospedale di Portogruaro
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VeneziaItalyUnknown status
AOUI Verona
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VeronaItalyUnknown status

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