Study Description
This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301). This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).
Interventions
Pelacarsen (TQJ230)
Eligibility Criteria
Inclusion Criteria:
* Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
* Participants who have completed the parent study EOS visit while still on assigned investigational product.
Exclusion Criteria:
* Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
* Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.
* Participants are receiving another investigational drug or device before the open-label treatment period.
* Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.
Other protocol-defined inclusion/exclusion criteria may apply.
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Mar del Plata,Buenos Aires,7600,Argentina
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CABA,Buenos Aires,1407,Argentina
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Caba,Buenos Aires,C1119acn,Argentina
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Ramos Mejía,Buenos Aires,B1704etd,Argentina
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CABA,Buenos Aires F.D.,1426,Argentina
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Córdoba,Córdoba Province,5000,Argentina
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San Miguel de Tucumán,San Miguel de Tucuman,4000,Argentina
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San Miguel de Tucumán,San Miguel de Tucuman,T4000icl,Argentina
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Rosario,Santa Fe Province,2000,Argentina
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Rosario,Santa Fe Province,S200cvd,Argentina
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Santa Fe,Santa Fe Province,S3000fwo,Argentina
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Buenos Aires,C1280aeb,Argentina
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Caba,C1426,Argentina
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Capital Federal,C1023aab,Argentina
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Corrientes,W3400cds,Argentina
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San Luis,D5702jrs,Argentina
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Camperdown,New South Wales,2050,Australia
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Liverpool,New South Wales,2170,Australia
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Chemside,Queensland,4032,Australia
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Woolloongabba,Queensland,4102,Australia
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Clayton,Victoria,3168,Australia
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Perth,Western Australia,6000,Australia
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Linz,4021,Austria
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Salzburg,5020,Austria
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Vienna,1210,Austria
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Huy,4500,Belgium
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Brussels,Brussels Capital,1070,Belgium
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Genk,Limburg,3600,Belgium
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Aalst,Oost Vlaanderen,9300,Belgium
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Bruges,8000,Belgium
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Dendermonde,9200,Belgium
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Santo André,São Paulo,09090-790,Brazil
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São Paulo,São Paulo,01323 000,Brazil
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Vitória,Espírito Santo,29055-450,Brazil
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Goiânia,Goiás,74605-020,Brazil
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Belo Horizonte,Minas Gerais,30150-270,Brazil
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Belo Horizonte,Minas Gerais,30150-320,Brazil
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Juiz de Fora,Minas Gerais,36033-318,Brazil
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Uberlândia,Minas Gerais,38400 500,Brazil
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Curitiba,Paraná,80730-150,Brazil
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Canoas,Rio Grande do Sul,92425 900,Brazil
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Porto Alegre,Rio Grande do Sul,90880-480,Brazil
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Aracaju,Sergipe,49055-530,Brazil
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Campinas,São Paulo,13060 080,Brazil
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Campinas,São Paulo,13092133,Brazil
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Ribeirão Preto,São Paulo,14026-020,Brazil
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Santo André,São Paulo,09060-870,Brazil
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Sao Jose Rio Preto,São Paulo,15015-750,Brazil
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Sao Jose Rio Preto,São Paulo,15090 000,Brazil
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São Paulo,São Paulo,04005-003,Brazil
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São Paulo,São Paulo,04266 010,Brazil
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Rio de Janeiro,20241-180,Brazil
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Burgas,8001,Bulgaria
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Pernik,2300,Bulgaria
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Pleven,5800,Bulgaria
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Plovdiv,4000,Bulgaria
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Rousse,7002,Bulgaria
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Sofia,1233,Bulgaria
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Beijing,Beijing Municipality,100013,China
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Lanzhou,Gansu,730030,China
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Foshan,Guangdong,528000,China
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Guangzhou,Guangdong,510030,China
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Guangzhou,Guangdong,510080,China
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Harbin,Heilongjiang,150000,China
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Changsha,Hunan,410003,China
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Changsha,Hunan,410008,China
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Changsha,Hunan,410011,China
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Baotou,Inner Mongolia,014040,China
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Nanjing,Jiangsu,210009,China
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Nanjing,Jiangsu,210029,China
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Nanjing,Jiangsu,211166,China
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Suzhou,Jiangsu,215004,China
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Xuzhou,Jiangsu,221003,China
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Changchun,Jilin,130021,China
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Dalian,Liaoning,116011,China
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Shenyang,Liaoning,110004,China
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Shenyang,Liaoning,110016,China
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Jinan,Shandong,250013,China
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Xian,Shanxi,710061,China
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Chengdu,Sichuan,610041,China
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Ürümqi,Xinjiang,830054,China
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Hangzhou,Zhejiang,310014,China
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Hangzhou,Zhejiang,310016,China
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Wenzhou,Zhejiang,325000,China
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Beijing,100050,China
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Beijing,100191,China
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Beijing,100730,China
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Shanghai,200025,China
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Shanghai,200040,China
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Shanghai,200065,China
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Shanghai,200120,China
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Tianjin,030045,China
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Tianjin,300052,China
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Tianjin,300121,China
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Xiamen,361004,China
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San Gil,684031,Colombia
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Barranquilla,Colombia,080020,Colombia
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Cali,Valle del Cauca Department,760032,Colombia
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Bogotá,111211,Colombia
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Medellín,050037,Colombia
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Kroměříž,Czech Republic,767 55,Czechia
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Brno,602 00,Czechia
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Brno,625 00,Czechia
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Broumov,550 01,Czechia
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Český Krumlov,381 01,Czechia
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Kolín,280 20,Czechia
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Most,434 01,Czechia
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Ostrava,Zabreh,700 30,Czechia
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Pardubice,532 03,Czechia
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Prague,128 08,Czechia
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Trutnov,460 63,Czechia
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Uherské Hradiště,686 01,Czechia
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Valašské Meziříčí,75742,Czechia
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Chlumec nad Cidlinou,Chlumec Nad Cidlinou,503 51,Czechia
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Louny,Czech Republic,440 01,Czechia
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Ostrava,Czech Republic,725 27,Czechia
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Ústí nad Labem,Czech Republic,400 01,Czechia
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Brandýs nad Labem,250 01,Czechia
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Prague,110 00,Czechia
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Hlučín,748 01,Czechia
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Hodonín,695 01,Czechia
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Jihlava,586 01,Czechia
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Liberec,460 01,Czechia
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Liberec,460 05,Czechia
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Mariánské Lázně,353 01,Czechia
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Mělník,276 01,Czechia
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Olomouc,779 00,Czechia
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Polička,57201,Czechia
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Přerov,751 52,Czechia
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Slaný,274 01,Czechia
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Třebíč,674 01,Czechia
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Zlín,760 01,Czechia
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Aarhus N,8200,Denmark
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Copenhagen,Dk-2100,Denmark
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Esbjerg,6700,Denmark
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Gistrup,9260,Denmark
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Herlev,Dk-2730,Denmark
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Roskilde,4000,Denmark
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Viborg,8800,Denmark
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Chambray-lès-Tours,37170,France
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Le Coudray,28630,France
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Nantes,44093,France
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Valenciennes,59300,France
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Frankfurt am Main,Hesse,60590,Germany
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Hanover,Lower Saxony,30159,Germany
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Jena,Thuringia,07740,Germany
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Dortmund,44137,Germany
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Essen,45277,Germany
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Lüneburg,21339,Germany
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Magdeburg,39120,Germany
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Meissen,01662,Germany
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München,80636,Germany
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Mannheim,Baden-Wurttemberg,68305,Germany
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Muehldorf Am Inn,Bavaria,84453,Germany
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Munich,Bavaria,81377,Germany
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Weiden in Der Oberpfalz,Bavaria,92637,Germany
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Frankfurt am Main,Hesse,60594,Germany
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Cologne,North Rhine-Westphalia,50733,Germany
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Cologne,North Rhine-Westphalia,50937,Germany
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Essen,45355,Germany
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Löhne,North Rhine-Westphalia,32584,Germany
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Saint Ingbert,Saarland,66386,Germany
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Chemnitz,Saxony,09113,Germany
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Dresden,Saxony,01099,Germany
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Dresden,01307,Germany
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Leipzig,Saxony,04103,Germany
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Wittenberg,Saxony-Anhalt,06886,Germany
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Aachen,52074,Germany
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Bad Homburg,61348,Germany
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Bad Krozingen,79189,Germany
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Bad Oeynhausen,32545,Germany
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Bamberg,96049,Germany
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Berlin,10367,Germany
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Berlin,10559,Germany
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Berlin,10787,Germany
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Berlin,10789,Germany
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Berlin,13347,Germany
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Berlin,13353,Germany
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Bielefeld,33604,Germany
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Dessau,06846,Germany
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Dresden,01069,Germany
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Dresden,01277,Germany
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Essen,45359,Germany
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Gelnhausen,63571,Germany
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Hamburg,22041,Germany
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Hamburg,22607,Germany
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Kassel,34121,Germany
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Mannheim,68165,Germany
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Münster,48149,Germany
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Potsdam,14471,Germany
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Rüdersdorf,15562,Germany
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Ulm,89077,Germany
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Warendorf,48231,Germany
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Larissa,411 10,Greece
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Hong Kong,999077,Hong Kong
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Debrecen,Hajdu Bihar Megye,4032,Hungary
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Baja,6500,Hungary
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Budapest,H-1083,Hungary
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Budapest,H-1145,Hungary
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Szeged,6725,Hungary
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Dehradun,Uttarakhand,248001,India
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Guntur,Andhra Pradesh,522001,India
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Ahmedabad,Gujarat,380054,India
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Ahmedabad,Gujarat,380060,India
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Vadodara,Gujarat,390022,India
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Belagavi,Karnataka,590010,India
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Mangalore,Karnataka,575018,India
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Manipal,Karnataka,576104,India
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Mysore,Karnataka,570015,India
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Kochi,Kerala,682018,India
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Kochi,Kerala,682027,India
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Kochi,Kerala,682041,India
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Nagpur,Maharashtra,440008,India
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Nagpur,Maharashtra,440012,India
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Nagpur,Maharashtra,440025,India
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Nagpur,Maharashtra,440033,India
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Nashik,Maharashtra,422005,India
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Pune,Maharashtra,411004,India
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Pune,Maharashtra,411028,India
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Pune,Maharashtra,411045,India
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New Delhi,National Capital Territory of Delhi,110060,India
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New Delhi,National Capital Territory of Delhi,110075,India
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Bikaner,Rajasthan,334003,India
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Chennai,Tamil Nadu,600006,India
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Coimbatore,Tamil Nadu,641009,India
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Coimbatore,Tamil Nadu,641037,India
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Hyderabad,Telangana,500034,India
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Hyderabad,Telangana,500082,India
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Secunderabad,Telangana,500003,India
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Ghaziabad,Uttar Pradesh,201012,India
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Lucknow,Uttar Pradesh,226003,India
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New Delhi,110025,India
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Haifa,3436212,Israel
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Beersheba,8457108,Israel
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Haifa,3104802,Israel
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Jerusalem,9112001,Israel
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Petah Tikva,4941492,Israel
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Ramat Gan,5265601,Israel
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Bergamo,BG,24127,Italy
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Brescia,BS,25123,Italy
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Milan,MI,20138,Italy
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Milan,MI,20149,Italy
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Milan,MI,20162,Italy
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Rozzano,MI,20089,Italy
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Ancona,AN,60128,Italy
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Bologna,BO,40138,Italy
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Florence,FI,50134,Italy
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Pozzilli,IS,86077,Italy
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Milan,MI,20132,Italy
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Palermo,PA,90127,Italy
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Perugia,PG,06129,Italy
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Pisa,PI,56124,Italy
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Pisa,PI,56126,Italy
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Roma,RM,00161,Italy
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Roma,RM,00189,Italy
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Varese,VA,21100,Italy
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Naples,80131,Italy
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Seto,Aichi-ken,4898642,Japan
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Kitakyushu,Fukuoka,8028555,Japan
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Kure,Hiroshima,737-0023,Japan
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Kawasaki,Kanagawa,2120021,Japan
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Miyhazaki,Miyazaki,8802102,Japan
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Chuo-ku,Tokyo,1030027,Japan
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Itabashi-ku,Tokyo,1738610,Japan
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Tiel,Gelderland,4002 wp,Netherlands
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Sneek,Provincie Friesland,8601 zk,Netherlands
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Apeldoorn,Gelderland,7334 dz,Netherlands
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Arnhem,Gelderland,6815 ad,Netherlands
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Heerlen,Limburg,6419 pc,Netherlands
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Tilburg,North Brabant,5042 ad,Netherlands
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Amsterdam,North Holland,1090 hm,Netherlands
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Heemstede,North Holland,2035 rc,Netherlands
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Leiderdorp,South Holland,2353 ga,Netherlands
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Amersfoort,3813 tz,Netherlands
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Hardenberg,7770 se,Netherlands
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Utrecht,3584 cx,Netherlands
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Venlo,5912 bl,Netherlands
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Bielsko-Biala,43-316,Poland
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Gdansk,80-214,Poland
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Gdynia,81-157,Poland
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Lodz,93-338,Poland
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Tarnów,33-100,Poland
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Coimbra,3004-561,Portugal
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Guimarães,4835-044,Portugal
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Setúbal,2910-549,Portugal
Research and Cardiovascular Corp
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Ponce,00717-1322,Puerto Rico
Jose B Vazquez-Tanus
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Baia Mare,Maramureş,430123,Romania
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Buzău,Buzău,120133,Romania
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Craiova,Dolj,200513,Romania
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Baia Mare,Maramureş,430222,Romania
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Bucharest,010192,Romania
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Bucharest,050098,Romania
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Saint Petersburg,Russia,198328,Russia
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Saint Petersburg,195197,Russia
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Saint Petersburg,196143,Russia
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Saint Petersburg,197341,Russia
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Saint Petersburg,199178,Russia
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Tomsk,634009,Russia
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Yaroslavl,150062,Russia
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Yekaterinburg,620137,Russia
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Yekaterinburg,620144,Russia
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Bardejov,085 01,Slovakia
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Handlová,972 51,Slovakia
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Trnava,Slovakia,917 02,Slovakia
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Bratislava,821 07,Slovakia
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Bratislava,833 05,Slovakia
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Bratislava,833 48,Slovakia
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Bratislava,851 07,Slovakia
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Komárno,945 01,Slovakia
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Komárno,945 05,Slovakia
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Košice,040 01,Slovakia
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Nitra,949 01,Slovakia
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Nitra,949 11,Slovakia
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Nitra,950 01,Slovakia
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Nové Zámky,940 01,Slovakia
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Považská Bystrica,017 01,Slovakia
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Daegu,Dalseo gu,42602,South Korea
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Wŏnju,Gangwon-do,26426,South Korea
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Bundang Gu,Gyeonggi-do,13620,South Korea
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Suwon,Gyeonggi-do,16499,South Korea
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Incheon,Korea,405 760,South Korea
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Seoul,Korea,02841,South Korea
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Seoul,Seoul,03080,South Korea
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Busan,49201,South Korea
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Gwangju,61469,South Korea
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Seoul,03181,South Korea
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Seoul,06591,South Korea
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Badalona,Barcelona,08916,Spain
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L'Hospitalet de Llobregat,Barcelona,08907,Spain
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Cáceres,Extremadura,10003,Spain
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A Coruña,15001,Spain
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Córdoba,14004,Spain
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Huelva,21080,Spain
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Málaga,29010,Spain
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Seville,41009,Spain
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Santiago Compostela,A Coruna,15706,Spain
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Santander,Cantabria,39008,Spain
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Barcelona,08025,Spain
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Barcelona,08036,Spain
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Madrid,28040,Spain
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Seville,41013,Spain
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Zaragoza,50009,Spain
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Lausanne,1010,Switzerland
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Liestal,4410,Switzerland
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Basel,4031,Switzerland
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Bern,3010,Switzerland
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Geneva,1211,Switzerland
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Zurich,8091,Switzerland
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Taichung,Taiwan ROC,40201,Taiwan
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Hsinchu,30069,Taiwan
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Kaohsiung City,80756,Taiwan
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Kaohsiung City,83301,Taiwan
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Keelung,20401,Taiwan
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Tainan,71004,Taiwan
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Izmir,Balcova,35340,Turkey (Türkiye)
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Istanbul,Kadikoy,34668,Turkey (Türkiye)
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Eskişehir,Odunpazari,26040,Turkey (Türkiye)
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Izmir,35100,Turkey (Türkiye)
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Ankara,Bilkent-Cankaya,06800,Turkey (Türkiye)
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Samsun,Samsun,55080,Turkey (Türkiye)
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Newport,Np20 2ub,United Kingdom
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Sheffield,S5 7au,United Kingdom
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London,GBR,Ec1m 6bq,United Kingdom
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London,Greater London,En3 4gs,United Kingdom
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Rochdale,North Manchester,Ol11 4au,United Kingdom
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Chertsey,Surrey,Kt16 0pz,United Kingdom
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Cardiff,Wales,Cf5 4ad,United Kingdom
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Chichester,West Sussex,Po19 6se,United Kingdom
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Chesterfield,S40 4aa,United Kingdom
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Glasgow,G20 7be,United Kingdom
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Wiltshire,Sn15 2sb,United Kingdom
UCSF
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San Francisco,California,94115,United States
Eveline O Stock
Helping Hands Medical Associates INC
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Santa Ana,California,92704,United States
Alan Charles Schwartz
Manshadi Heart Institute
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Stockton,California,95204,United States
Delaina Sanguinetti
Ramin Manshadi
Interv Cardiology Med Grp
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West Hills,California,91307,United States
Farhad Rafii
Wayne State University
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Detroit,Michigan,48201,United States
Brian J O Neil
Wake Forest University Baptist Medical Center
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Winston-Salem,North Carolina,27157,United States
Herman Barrett Cheek
Cardiology Consultants of Philadelphia
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Yardley,Pennsylvania,19067,United States
Paul Grena
Virginia Heart
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Falls Church,Virginia,22042,United States
Jared Spitz
Joanne Wotring
Tariq Haddad
SEC Clinical Research LLC
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Andalusia,Alabama,36420,United States
Andreas Muench
Heart Center Research Llc
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Huntsville,Alabama,35801,United States
Vernon R Hunter
Mobile Heart Specialists
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Mobile,Alabama,36608,United States
Christopher S Brown
Mercy Gilbert Medical Center
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Gilbert,Arizona,85297,United States
Nabil Dib
Clinical Research Inst of Arizona
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Sun City West,Arizona,85375,United States
Jalal Abbas
Eclipse Clinical Research
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Tucson,Arizona,85745,United States
Eve Shapiro
Cardiovascular Res Found
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Beverly Hills,California,90210,United States
Ronald P Karlsberg
National Heart Institute
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Beverly Hills,California,90211,United States
Norman Lepor
Chase Medical Research LLC
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Waterbury,Connecticut,06708,United States
Joseph Soufer
Bay Area Cardiology Assoc
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Brandon,Florida,33511,United States
Ranchhod Khant
Jacksonville Center for Clinical Research
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Jacksonville,Florida,32216,United States
Michael J Koren
Advanced Research for Health Improvement LLC
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Naples,Florida,34102,United States
Julian Javier
Peace River Cardiovascular Center
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Port Charlotte,Florida,33952,United States
David Allan Hotchkiss
Progressive Medical Research
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Port Orange,Florida,32127,United States
Alexander J White
East Coast Inst for Research LLC
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Saint Augustine,Florida,32086,United States
Ferris George
Cardiology Partners Clinical Research Institute
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Wellington,Florida,33449,United States
Neerav Suresh Shah
Emory University
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Atlanta,Georgia,30322,United States
Arshed Quyyumi
Cardiovascular Consultants of S GA
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Thomasville,Georgia,31792,United States
Christopher Daniels
Krannert Institute of Cardiology
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Indianapolis,Indiana,46202 4800,United States
Julie Clary
University of Kansas Hospital
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Kansas City,Kansas,66160,United States
Patrick M Moriarty
Cotton O Neil Clinical Res Center
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Topeka,Kansas,66606,United States
Michael Cox
Louisiana Heart Center Research
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Covington,Louisiana,70433,United States
Bruce J Iteld
Dale Presser
Frank Voelker
Horizon Research Grp
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Lafayette,Louisiana,70501,United States
Randall Miller
Omega Clinical Research
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Metairie,Louisiana,70006,United States
Tuan-Huy Tran
CV Ins of the South
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Opelousas,Louisiana,70570,United States
Siby George Ayalloore
Grace Research Llc
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Shreveport,Louisiana,71105,United States
Anil Chhabra
Southern Clinical Research
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Zachary,Louisiana,70791,United States
Ernest Thompson
Sinai Ct for Throm Res and Drug Dev
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Baltimore,Maryland,21209,United States
Paul Gurbel
Anderson Medical Research
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Ft. Washington,Maryland,20744,United States
Ann-Marie Cobb
Felton Anderson
Adventist HealthCare Shady Grove Medical Center
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Rockville,Maryland,20850,United States
Michael Chen
MGH
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Boston,Massachusetts,02114 2696,United States
Imuetiyan Eweka
Maria T Vivaldi
AA Medical Research Center
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Flint,Michigan,48504,United States
Ahmed A Arif
Western Michigan University
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Kalamazoo,Michigan,49008,United States
Debbi Hotchkiss
Vishal Gupta
Metro Health Univ of MI Health
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Wyoming,Michigan,49519,United States
Rony Gorges
Saint Johns Hospital
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Maplewood,Minnesota,55109,United States
Les B Forgosh
University Of Minnesota
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Minneapolis,Minnesota,55455,United States
Daniel Duprez
Stern Cardiovascular Foundation Inc
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Southaven,Mississippi,38671,United States
Dharmesh Patel
StudyMetrix Research
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City of Saint Peters,Missouri,63303,United States
Timothy Smith
Quality Clinical Research
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Omaha,Nebraska,68114,United States
John Hallgren
Overlook Medical Center
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Summit,New Jersey,07901,United States
Robert Fishberg
Rosmery Montesino
Northwell Health
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Manhasset,New York,11030,United States
Bani Azari
Weill Cornell Medical Center
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New York,New York,10021,United States
Samuel Kim
Lenox Hill Hospital
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New York,New York,43210,United States
Eugenia Gianos
Lauren Senia
Northwell Health Physician Peconic
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Riverhead,New York,11901,United States
Sean Donahoe
Novant Health Heart Vas Inst
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Charlotte,North Carolina,28204,United States
Anish Vani
Medication Management LLC
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Greensboro,North Carolina,27405,United States
James Franklin
Accellacare US Inc
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Raleigh,North Carolina,27609,United States
John Rubino
Aultman Hospital
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Canton,Ohio,44710,United States
Ramana Podugu
Lindner Ctr At The Christ Hosp
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Cincinnati,Ohio,45219,United States
Dean J Kereiakes
Rama Research LLC
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Marion,Ohio,43302,United States
Bhola Rama
Lancaster General Health
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Lancaster,Pennsylvania,17603,United States
Kay Knepper
Marjan U Mujib
Monument Health Clinical Research
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Rapid City,South Dakota,57701,United States
Stephen Wasemiller
The Stern Cardiovascular Foundation
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Germantown,Tennessee,38138,United States
Frank Augustus McGrew
Cardiovascular Res of Knoxville LLC
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Powell,Tennessee,37849,United States
Charles B Treasure
Soltero Cardiovascular Research Center
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Dallas,Texas,75226,United States
Cara East
North Texas Endocrine Center
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Dallas,Texas,75231,United States
Peter Bressler
SW Family Medicine Associates
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Dallas,Texas,75235,United States
Chrisette Dharma
Grace Research
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Marshall,Texas,75670,United States
William Eaves
Northwest Houston Clinical Research PLLC
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Tomball,Texas,77375,United States
Shamaila Aslam
Progressive Clinical Research
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Bountiful,Utah,84010,United States
Joshua Oaks
The University of Utah
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Salt Lake City,Utah,84132-0001,United States
Aaron Shoskes
Carient Heart and Vascular
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Manassas,Virginia,20109,United States
Vikram Prasanna
Dominion Medical Associates
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Richmond,Virginia,23219,United States
Richard A Jackson
Harborview Medical Center
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Seattle,Washington,98104,United States
Francis Kim
Swedish Medical Center-Cardiovascular Research
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Seattle,Washington,98122,United States
John Petersen II
West Virginia University Hospital
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Morgantown,West Virginia,26506,United States
Sudarshan Balla
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