Study Description
This is a multicenter, randomized, placebo- and active-controlled, parallel-group,
24-week trial to investigate the efficacy, safety, and tolerability of XXB750 in
participants with HFrEF/HFmrEF. Eligible participants will be randomized to receive either subcutaneous (s.c.) XXB750 or
placebo; or sacubitril/valsartan for 16 weeks, and then followed-up for 8 weeks
Interventions
Placebo
Sacubitril/valsartan
XXB750 High Dose
XXB750 Low dose
XXB750 Medium Dose
Eligibility Criteria
Inclusion Criteria:
- Current symptom(s) of HF NYHA class II-III and LVEF < 50%
- Elevated NT-proBNP levels at screening.
- Receiving standard of care background HF therapy.
Exclusion Criteria:
- Current acute decompensated HF or hospitalization for HF within 3 months prior to
screening.
- Current symptomatic hypotension (for example dizziness/presyncope).
- K+ > 5.4 mmol/L at screening
- eGFR < 30 mL/min/1.73m2 at screening
Other protocol-specific criteria may apply.
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Gabrovo,5300,Bulgaria
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Stara Zagora,6000,Bulgaria
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Kyustendil,2500,Bulgaria
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Varna,9010,Bulgaria
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Pleven,5800,Bulgaria
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Plovdiv,4002,Bulgaria
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Sofia,1233,Bulgaria
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Sofia,1510,Bulgaria
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Blagoevgrad,270 0,Bulgaria
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Sofia,1709,Bulgaria
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Beijing,100029,China
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Changchun,Jilin,130041,China
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Beijing,100730,China
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Shenyang,Liaoning,110003,China
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Jinan,250012,China
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Shanghai,Shanghai,200032,China
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Guangzhou,Guangdong,510080,China
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Xian,Shanxi,710061,China
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Guangzhou,Guangdong,510515,China
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Chengdu,Sichuan,610041,China
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Luoyang,Henan,471002,China
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Tianjin,Tianjin,300121,China
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Changzhou,Jiangsu,213004,China
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Brno,Czech Republic,60200,Czechia
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Liberec,46063,Czechia
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Praha,10034,Czechia
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Praha,12808,Czechia
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Herlev,Dk 2730,Denmark
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Hvidovre,2650,Denmark
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Roskilde,4000,Denmark
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Montpellier,34295,France
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Paris cedex 10,75010,France
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Rennes,35033,France
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Beziers Cedex,34525,France
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Rouen,76031,France
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Chambray les Tours,37170,France
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Saint Herblain - Nantes,44093,France
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Creteil,94010,France
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Toulouse 4,31054,France
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Ludwigshafen,67063,Germany
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Frankfurt,60590,Germany
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Essen,Nordrhein Westfalen,45355,Germany
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Ludwigshafen,67067,Germany
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Frankfurt,60594,Germany
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Dresden,Sachsen,01099,Germany
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Neuwied,56564,Germany
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Gladbeck,45968,Germany
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Berlin,10787,Germany
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Papenburg,26871,Germany
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Kiel,24105,Germany
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Berlin,13347,Germany
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Schwaebisch Hall,74523,Germany
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Koeln,51065,Germany
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Coburg,96450,Germany
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Stuttgart,70376,Germany
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Leipzig,04289,Germany
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Dresden,01307,Germany
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Balatonfured,8230,Hungary
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Mosanmagyarovar,9200,Hungary
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Budapest,Pest Megye,1134,Hungary
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Bikaner,Rajasthan,334003,India
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Belgavi,590010,India
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Brescia,BS,25123,Italy
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Reggio Emilia,RE,42123,Italy
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Cona,FE,44100,Italy
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Roma,RM,00133,Italy
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Messina,ME,98125,Italy
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Roma,RM,00161,Italy
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Milano,MI,20138,Italy
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Trieste,TS,34149,Italy
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Padova,PD,35128,Italy
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Ancona,AN,60128,Italy
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Napoli,80131,Italy
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Pisa,PI,56126,Italy
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Bergamo,BG,24127,Italy
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Pordenone,PN,33170,Italy
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Itabashi-ku,Tokyo,173-8610,Japan
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Maebashi city,Gunma,371 8511,Japan
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Kawasaki,Kanagawa,216-8511,Japan
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Sagamihara,Kanagawa,252-0375,Japan
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Matsumoto,Nagano,390-8621,Japan
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Kawaguchi-city,Saitama,333-0842,Japan
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Hachioji,Tokyo,192-0918,Japan
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Koriyama,Fukushima,963-8501,Japan
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Rotterdam,Zuid Holland,3015 gd,Netherlands
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Groningen,9713 gz,Netherlands
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Heerlen,6419 pc,Netherlands
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Leeuwarden,8934 ad,Netherlands
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Nijmegen,6500hb,Netherlands
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Lisboa,1500 650,Portugal
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Vila Nova De Gaia,4434 502,Portugal
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Lisboa,1495 005,Portugal
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Nove Zamky,940 01,Slovakia
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Presov,080 01,Slovakia
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Svidnik,089 01,Slovakia
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Bardejov,085 01,Slovakia
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Kosice,040 01,Slovakia
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Martin,036 01,Slovakia
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Nitra,949 01,Slovakia
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Madrid,28040,Spain
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Valencia,Comunidad Valenciana,46010,Spain
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Madrid,28041,Spain
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Santiago De Compostela,Galicia,15706,Spain
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Madrid,28222,Spain
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El Palmar,Murcia,30120,Spain
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Huelva,Andalucia,21005,Spain
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Valencia,46026,Spain
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Alicante,03700,Spain
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Malaga,Andalucia,29010,Spain
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Las Palmas de Gran Canaria,35010,Spain
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Sevilla,Andalucia,41014,Spain
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Madrid,28034,Spain
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Utrera,Andalucia,41710,Spain
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Taipei,11217,Taiwan
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Kaohsiung,80756,Taiwan
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Taichung,40447,Taiwan
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Tainan,71004,Taiwan
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East Yorkshire,Hu16 5jq,United Kingdom
Cambridge Medical Trials .
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Alexandria,Louisiana,71301,United States
Naseem A Jaffrani
SEC Clinical Research Research
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Dothan,Alabama,36305,United States
Robert I Garver
Baylor University Medical Center Facility
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Dallas,Texas,75246,United States
Kiersten Schneider
Parag Kale
Troy Internal Medicine Research .
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Troy,Michigan,48098,United States
Neil J. Fraser
Megan Nicholas
East Coast Institute for Research East Coast Inst for Res ECIR
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Jacksonville,Florida,32223,United States
Jerry W Chandler
Leann Petschonek
Cardiology Partners Clinical Research Institute
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Wellington,Florida,33449,United States
Jean Foucauld
Clinical Research of Rock Hill
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Rock Hill,South Carolina,29732,United States
Michael Denenberg
Sinai Ctr Thrombois Res Drug Dev
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Baltimore,Maryland,21215,United States
Paul Gurbel
Hartford Healthcare Headache Center Research
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West Hartford,Connecticut,06109,United States
Abhishek Jaiswal
Grace Research .
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Marshall,Texas,75670,United States
William Eaves
Clinilabs Inc Clinilabs
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New York,New York,10019,United States
Magdy Shenouda
University Of Cincinnati UCMC Facility Address
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Cincinnati,Ohio,45267,United States
Harshada More
Umama Gorsi
Ormond Beach Clinical Research
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Ormond Beach,Florida,32174,United States
Taylor Lenholt
Dinesh Arab
Heart Center Research Llc .
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Huntsville,Alabama,35801,United States
Kaushik K Jain
Fairview Health Services St Johns
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Saint Paul,Minnesota,55103,United States
Alexandra Clute
Les Forgosh
American Clinical Trials
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Acworth,Georgia,30101,United States
Chinedu Nweke
Iasia Williams
Dominion Medical Associates
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Richmond,Virginia,23219,United States
Richard A Jackson
St Johns Center Research
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Ponte Vedra,Florida,32801,United States
Ameeth Vedre
Kimberly McKenzie
John Peter Smith Hospital
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Fort Worth,Texas,76104,United States
Sandeep Kamath
Whitney Cromartie
Heart Clinic of Hammond .
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Hammond,Louisiana,70403,United States
Ghiath Mikdadi
Inpatient Research Clinical LLC
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Miami Lakes,Florida,33014,United States
Alexis Gutierrez
Tennessee Center For Clinical Trials .
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Tullahoma,Tennessee,37388,United States
Dinesh Gupta
Anderson Medical Research Main Center
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Fort Washington,Maryland,20744,United States
Felton Anderson
Nature Coast Clinical Research LLC
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Inverness,Florida,34452,United States
Rafik Abadier
Laurelton Heart Specialist PC Research
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Rosedale,New York,11422,United States
Bomi Odumosu
Olakunle Akinboboye
NexGen Research
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Lima,Ohio,45805,United States
Nonso Ezema
Pima Heart And Vascular Clin Rch Research
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Tucson,Arizona,85704,United States
Ajay Tuli
Natheer Aljanabi
Washington Univ School of Medicine
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Saint Louis,Missouri,63110,United States
Greg Ewald
Reid Hosp And Hlth Care Services
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Richmond,Indiana,47374,United States
John McGinty
Nancy Fry
Universal Research Group LLC Suite 202
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Tacoma,Washington,98405,United States
Sabrina Benjamin
Revival Research Institute .
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Troy,Michigan,48084,United States
Khalida Makin
Qaiser Shafiq
East Coast Inst for Research LLC
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Saint Augustine,Florida,32086,United States
Ferris George
Northwest Houston Cardiology PA Horizons Clin Resrch Group
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Houston,Texas,77070,United States
Aditya Samal
Grace Research Llc .
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Shreveport,Louisiana,71101,United States
Anil Chhabra
Miami Clinical Research .
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Miami,Florida,33155,United States
Keila Hoover
Mariana Wefer
Cypress Heart and Vascular Center
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Cypress,Texas,77429,United States
Fadi Alameddine
Jacksonville Ctr For Clin Rea Main Centre
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Jacksonville,Florida,32216,United States
Michael J Koren
Aultman Hospital
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Canton,Ohio,44710,United States
Ataul Qureshi
Prisma Health Research
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Columbia,South Carolina,29203,United States
Rebecca Napier
Suzanne Smith
Memorial Care Health System Memorialcare Long Beach
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Long Beach,California,90806,United States
Andrew Yoon
St Louis Heart and Vascular .
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Saint Louis,Missouri,63136,United States
Mohammad Tahir
The Research Group Lewis Hargett Circle
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Lexington,Kentucky,40503,United States
Justin Arambasick
University of Maryland Research
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Baltimore,Maryland,21201,United States
Manjula Ananthram
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