Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD

A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With Established Cardiovascular Disease

ClinicalTrials.gov Identifier: NCT04023552

Novartis Reference Number: CTQJ230A12301

Last Update: Apr 14, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

Condition 
Cardiovascular Disease and Lipoprotein(a)
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
7680 participants
Start date 
Dec 12, 2019
Completion date 
Mar 01, 2024
Gender 
All
Age(s)
18 Years - 80 Years (Adult, Older Adult)

Interventions

Drug
TQJ230
TQJ230 80 mg injected monthly administered subcutaneously
Drug
Placebo
Placebo to match TQJ230 prefilled syringe to be injected subcutaneously

Eligibility Criteria

Key Inclusion Criteria

Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory
Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
Clinically significant symptomatic peripheral artery disease

Key Exclusion Criteria

Uncontrolled hypertension
Heart failure New York Heart Association (NYHA) class IV
History of malignancy of any organ system
History of hemorrhagic stroke or other major bleeding
Platelet count ≤LLN
Active liver disease or hepatic dysfunction
Significant kidney disease
Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply at the end.

Study Locations

United States
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Andalusia, 36420
Alabama
United States
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Birmingham, 35243
Alabama
United States
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Huntsville, 35801
Alabama
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Mobile, 36608
Alabama
United States
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Cottonwood, 86326
Arizona
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Surprise, 85374
Arizona
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Tucson, 85745
Arizona
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Little Rock, 72204
Arkansas
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Beverly Hills, 90211
California
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Covina, 91723
California
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Huntington Beach, 92648
California
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Northridge, 91325
California
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West Hills, 91307
California
United States
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Boca Raton, 33434
Florida
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Bradenton, 34209
Florida
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Brandon, 33511
Florida
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Fort Lauderdale, 33312
Florida
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Jacksonville, 32205
Florida
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Jacksonville, 32216
Florida
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Miami, 33133
Florida
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Naples, 34102
Florida
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Port Charlotte, 33952
Florida
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Port Orange, 32127
Florida
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Wellington, 33449
Florida
United States
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Atlanta, 30084
Georgia
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Atlanta, 30309
Georgia
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Atlanta, 30322
Georgia
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Thomasville, 31792
Georgia
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Indianapolis, 46202 4800
Indiana
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Iowa City, 52242
Iowa
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Kansas City, 66160
Kansas
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Topeka, 66606
Kansas
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Alexandria, 71301
Louisiana
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Covington, 70433
Louisiana
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Hammond, 70403
Louisiana
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Houma, 70360
Louisiana
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Lafayette, 70501
Louisiana
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Metairie, 70006
Louisiana
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New Orleans, 70115
Louisiana
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Shreveport, 71101
Louisiana
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Slidell, 70458
Louisiana
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Zachary, 70791
Louisiana
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Baltimore, 21209
Maryland
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Baltimore, 21287
Maryland
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Columbia, 21044
Maryland
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Rockville, 20850
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Detroit, 48202
Michigan
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Petoskey, 49770
Michigan
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Wyoming, 49519
Michigan
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Yazoo City, 39194
Mississippi
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Saint Louis, 63110
Missouri
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Saint Peters, 63303
Missouri
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Lincoln, 68526
Nebraska
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Omaha, 68134
Nebraska
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Binghamton, 13901
New York
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Manhasset, 11030
New York
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Southampton, 11968
New York
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Charlotte, 28204
North Carolina
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Greensboro, 27408
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Sanford, 27330
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Shelby, 28150
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Winston-Salem, 27157
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Canton, 44710
Ohio
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Ohio
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Cincinnati, 45246
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Cleveland, 44195
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Dallas, 75231
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Dallas, 75235
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Houston, 77030
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Livingston, 77351
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Marshall, 75670
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Temple, 76508
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Norfolk, 23510
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Richmond, 23219
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Milwaukee, 53215
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Caba, 1407
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Caba, C1056ABJ
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Tucuman, T4000ICL
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Chemside, 4032
Queensland
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Southport, 4215
Queensland
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Clayton, 3168
Victoria
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Perth, 6000
Western Australia
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Austria
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Graz, 8036
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Innsbruck, 6020
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Linz, 4021
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Salzburg, A-5020
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Wien, 1090
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Wien, 1210
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Belgium
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Aalst, 9300
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Bruxelles, 1070
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Dendermonde, 9200
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Genk, 3600
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Huy, 4500
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Belgium
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Mechelen, 2800
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Belgium
Brazil
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Maceio, 57051 160
AL
Brazil
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Salvador, 40170-130
BA
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Brasilia, 70390-903
DF
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Vitoria, 29055-450
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Belo Horizonte, 30150-221
MG
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Belo Horizonte, 30220330
MG
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Uberlandia, 38411 186
Minas Gerais
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Parana
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PR
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Rio de Janeiro, 22271-100
RJ
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Porto Alegre, 90160093
RS
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Porto Alegre, 90880-480
RS
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Blumenau, 89020 430
Santa Catarina
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Aracaju, 49055530
SE
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Campinas, 13010-001
SP
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Campinas, 13060 080
SP
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Santo Andre, 09060-870
SP
Brazil
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Santo Andre, 09090-790
SP
Brazil
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Sao Jose do Rio Preto, 15015-750
SP
Brazil
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Sao Jose do Rio Preto, 15090 000
SP
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Sao Paulo, 04005-003
SP
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Sao Paulo, 04266 010
SP
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Sao Paulo, 05403-900
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Bulgaria
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Burgas, 8000
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Bulgaria
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Pernik, 2300
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Pleven, 5800
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Sofia, 1233
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Sofia, 1709
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Canada
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Lanzhou,
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Jiangsu
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Nanjing, 211166
Jiangsu
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Suzhou, 215006
Jiangsu
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Liaoning
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Shenyang, 110016
Liaoning
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Wenzhou, 325000
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Beijing, 100050
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Leipzig, 04103
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Germany
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Germany
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Loehne, 32584
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Germany
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Lutherstadt Wittenberg, 06886
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Germany
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Lüneburg, 21339
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Germany
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Magdeburg, 39120
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Germany
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Mannheim, 68165
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Germany
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Meißen, 01662
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Germany
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Muehldorf, 84453
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Germany
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Muenchen, 80636
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Germany
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Muenchen, 81377
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Germany
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Muenster, 48149
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Germany
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Northeim, 37154
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Germany
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Potsdam, 14471
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Germany
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Rüdersdorf, 15562
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Germany
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Saint Ingbert - Oberwuerzbach, 66386
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Germany
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Ulm, 89077
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Germany
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Warendorf, 48231
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Germany
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Thessaloniki, GR 54636
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Guatemala
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Guatemala City, 01010
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Guatemala
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Guatemala City, 01011
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Guatemala
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Guatemala, 01001
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Quetzaltenango, 09001
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Hong Kong, HONG KONG
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Hong Kong
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Pecs, 7621
Baranya
Hungary
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Pecs, 7624
Baranya
Hungary
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Szekesfehervar, H-8000
Fejer
Hungary
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Budapest, 1204
HUN
Hungary
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Baja, 6500
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Hungary
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Budapest, 1085
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Hungary
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Budapest, 1145
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Hungary
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Budapest, H-1097
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Hungary
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Debrecen, 4032
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Hungary
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Kistarcsa, 2143
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Hungary
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Mako, 6900
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Hungary
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Mateszalka, 4700
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Hungary
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Andhrapradesh
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Ahmedabad, 380 060
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Ahmedabad, 382428
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Vadodara, 390022
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Ahmedabad, 380060
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India
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Kochi, 682027
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Nagpur, 440009
Maharashtra
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Nagpur, 440012
Maharashtra
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Nashik, 422 005
Maharashtra
India
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Nashik, 422005
Maharashtra
India
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Pune, 411004
Maharashtra
India
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Pune,
Maharashtra
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Italy
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Italy
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Milano, 20132
MI
Italy
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MI
Italy
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Italy
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Italy
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Sendai city, 980 0873
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Korea
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Seoul, 03080
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Mexico
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Torreon, 27000
Coahulia
Mexico
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Apeldoorn, 7334
DZ
Netherlands
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Sneek, 8601 ZR
The Netherlands
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Amsterdam, 1090 HM
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Den Haag, 2545 CH
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Deventer, 7416 SE
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Groningen, 9728 NZ
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Heerlen, 6419
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Poznan,
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Setubal, 2910-446
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Russian Federation
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Chelyabinsk, 454047
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Russian Federation
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Ekaterinburg, 620137
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Russian Federation
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Ivanovo, 153012
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Russian Federation
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Izhevsk, 426061
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Russian Federation
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Kirov, 610035
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Russian Federation
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Krasnodar, 350086
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Russian Federation
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Moscow, 101990
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Russian Federation
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Moscow, 115516
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Russian Federation
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Moscow, 117198
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Russian Federation
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Moscow, 121552
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Russian Federation
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Moscow, 127473
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Russian Federation
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Moscow, 143420
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Russian Federation
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Novosibirsk, 630090
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Russian Federation
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Petrozavodsk, 185019
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Russian Federation
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Russian Federation
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Rostov on Don, 344022
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Russian Federation
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Ryazan, 390039
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Russian Federation
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Russian Federation
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Russian Federation
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Saint Petersburg, 195067
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Russian Federation
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Saint Petersburg, 195197
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Russian Federation
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Saint Petersburg, 197341
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Russian Federation
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Saint Petersburg, 198328
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Sochy, 354002
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Yekaterinburg, 620109
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Turcianske Teplice, 03901
Okr Turcianske Teplice
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Banska Bystrica, 974 01
Slovak Republic
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Slovak Republic
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Slovak Republic
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Rimavska Sobota, 97901
Slovak Republic
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Slovak Republic
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Handlova, 97251
SVK
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Zilinsky Kraj
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Slovakia
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Presov, 080 01
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South Africa
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Lenasia, 1827
Gauteng
South Africa
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Soweto, 2013
Gauteng
South Africa
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Western Cape
South Africa
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South Africa
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Cape Town,
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Spain
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Andalucia
Spain
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Andalucia
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Sevilla, 41013
Andalucia
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Andalucia
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Hospitalet de Llobregat, 08907
Barcelona
Spain
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Reus, 43201
Cataluna
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Catalunya
Spain
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Barcelona, 08036
Catalunya
Spain
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Extremadura
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Spain
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Switzerland
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Taiwan ROC
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Tainan, 71004
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Taiwan
Novartis Investigative Site
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Taipei, 11217
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Taiwan
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Taoyuan, 33305
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Taiwan
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Yilan, 26058
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Taiwan
Turkey
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Ankara, 06100
Cankaya
Turkey
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Eskisehir, 26480
Meselik
Turkey
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Haydarpasa Istanbul, 34668
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Turkey
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Istanbul, 34304
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Turkey
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Izmir, 35340
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Turkey
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Izmir,
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Turkey
Novartis Investigative Site
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Mersin, 33079
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Turkey
United Kingdom
Novartis Investigative Site
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London, EC1M 6BQ
GBR
United Kingdom
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Cardiff, CF5 4AD
Wales
United Kingdom
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Chichester, PO19 6SE
West Sussex
United Kingdom
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Glasgow, G20 0XA
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United Kingdom
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Harrow, HA1 3UJ
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United Kingdom
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Middlesbrough, TS4 3BW
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United Kingdom
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Newcastle upon Tyne, NE7 7DN
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United Kingdom
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Norwich, NR4 7UY
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United Kingdom
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Tyne And Wear, NE29 8NH
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United Kingdom
Novartis Investigative Site
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Wiltshire, SN15 2SB
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United Kingdom

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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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