Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction

A Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction

ClinicalTrials.gov Identifier: NCT02884206

Novartis Reference Number: CLCZ696B2320

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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

The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction. Cognitive function will be assessed using a comprehensive battery of tests with an evaluation of longitudinal change of cognitive domains including memory, executive function, and attention.

Condition 
Chronic Heart Failure (CHF)
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
592 participants
Start date 
Nov 23, 2016
Completion date 
Mar 28, 2022
Gender 
All
Age(s)
60 Years and older (Adult, Older Adult)

Interventions

Drug
LCZ696
LCZ696 50, 100, and 200 mg tablets taken orally twice daily with matching placebo for valsartan
Drug
Valsartan
Valsartan 40, 80, and 160 mg tablets taken orally twice daily with matching placebo for LCZ696
Drug
Placebo of LCZ696
Placebo to match LCZ696 50 mg, 100 mg, and 200 mg tablets
Drug
Placebo of Valsartan
Placebo to match valsartan 40 mg, 80 mg, and 160 mg tablets

Eligibility Criteria

Key Inclusion Criteria:

Chronic heart failure with current symptoms NYHA class II-IV
Left ventricular ejection fraction > 40%
NT-proBNP >= 125 pg/mL at screening visit
Patient with evidence of adequate functioning to complete study assessments

Key Exclusion Criteria:

Patients with acute decompensated heart failure requiring augmented therapy with diuretics, vasodilators and/or inotropic drugs
Acute coronary syndrome (including myocardial infarction (MI)), cardiac surgery, other major CV surgery, or urgent percutaneous coronary intervention (PCI), carotid surgery or carotid angioplasty, history of stroke or transient ischemic attack within the 3 months prior to Screening visit or an elective PCI within 30 days prior to Screening visit
Patients with history of hereditary or idiopathic angioedema or angioedema related to previous ACEi or ARB therapies
Patients who require treatment with 2 or more of the following: an ACEi, an ARB or a renin inhibitor

Patients with one of the following:

Patients with serum potassium >5.2 mmol/L (mEq/L) at Screening visit
Patients with serum potassium >5.4 mmol/L (mEq/L) at any visit during run-in treatment period or at randomization visit
Systolic blood pressure (SBP) ≥180 mmHg at Screening visit, or
SBP <110 mmHg at Screening visit, or
SBP <100 mmHg or symptomatic hypotension as determined by the investigator at Visit 103 or at randomization visit
Body mass index (BMI) >45 kg/m^2

Patients with

known pericardial constriction, genetic hypertrophic cardiomyopathy, infiltrative cardiomyopathy
hemodynamically significant obstructive valvular disease
Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate >110 beats per minute
Inability to perform cognitive battery or other study evaluations based on significant motor (e.g. hemiplegia, muscular-skeletal injury) or sensory (blindness, decreased or uncorrected visual or auditory acuity) skill
Clinically significant cerebral pathology for example large cerebral aneurysm or space occupying lesion that may impact cognition as assessed by central MRI reader
Mini mental state examination score less than 24 at screening
Patients with a clinical diagnosis of Alzheimer's disease or other dementia syndromes or any indication for or current treatment with cholinesterase inhibitors and/or another prescription AD treatment (e.g. memantine).

Study Locations

United States
Novartis Investigative Site
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Andalusia, 36420
Alabama
United States
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Glendale, 85306
Arizona
United States
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Mesa, 85206
Arizona
United States
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Phoenix, 85004
Arizona
United States
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Surprise, 85374
Arizona
United States
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Tucson, 85723
Arizona
United States
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Beverly Hills, 90211
California
United States
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Fresno, 93720
California
United States
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Loma Linda, 92357
California
United States
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Long Beach, 90806
California
United States
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Newport Beach, 92663
California
United States
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Santa Ana, 92704
California
United States
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Santa Ana, 92705
California
United States
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Torrance, 90503
California
United States
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Danbury, 06810
Connecticut
United States
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Clearwater, 33756
Florida
United States
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Edgewater, 32132
Florida
United States
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Hollywood, 33312
Florida
United States
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Homestead, 33030
Florida
United States
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Inverness, 34452
Florida
United States
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Jacksonville Beach, 32050
Florida
United States
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Miami, 33133
Florida
United States
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Miami, 33144
Florida
United States
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Miami, 33176
Florida
United States
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Naples, 34102
Florida
United States
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Port Orange, 32127
Florida
United States
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Tampa, 33612
Florida
United States
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Lombard, 60148
Illinois
United States
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Springfield, 62701
Illinois
United States
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Topeka, 66606
Kansas
United States
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Eunice, 70535
Louisiana
United States
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Baltimore, 21229
Maryland
United States
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Saginaw, 48601
Michigan
United States
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Saint Louis, 63110
Missouri
United States
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Kalispell, 59901 3158
Montana
United States
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Reno, 89502
Nevada
United States
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Elmer, 08318
New Jersey
United States
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Buffalo, 14215
New York
United States
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Gastonia, 28054
North Carolina
United States
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Cincinnati, 45219
Ohio
United States
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Oregon City, 97045
Oregon
United States
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Springfield, 97477
Oregon
United States
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Fort Mill, 29707
South Carolina
United States
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Rock Hill, 29732
South Carolina
United States
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Summerville, 29485
South Carolina
United States
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Dallas, 75226
Texas
United States
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Dallas, 75235
Texas
United States
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Gonzales, 78629
Texas
United States
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Houston, 77030
Texas
United States
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Lufkin, 75904
Texas
United States
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San Antonio, 78229
Texas
United States
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Tacoma, 98405
Washington
United States
Argentina
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Buenos Aires, C1405BCK
ARG
Argentina
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Caba, 1407
Buenos Aires
Argentina
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Ciudad Autonoma de Bs As, C1119ACN
Buenos Aires
Argentina
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Ramos Mejia, B1704ETD
Buenos Aires
Argentina
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Caba, C1179AAB
Capital Federal
Argentina
Australia
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Chemside, 4032
Queensland
Australia
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Milton, 4064
Queensland
Australia
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Bedford Park, 5042
South Australia
Australia
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Geelong, 3220
Victoria
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Belgium
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Aalst, 9300
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Belgium
Bulgaria
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Sofia, 1407
BGR
Bulgaria
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Sofia, 1431
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Bulgaria
Canada
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Hamilton, L8L 2X2
Ontario
Canada
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Greenfield Park, J4V 2G8
Quebec
Canada
Croatia
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Rijeka, 51000
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Croatia
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Zagreb, 10000
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Croatia
France
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Paris, 75013
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France
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Tourcoing, 59208
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France
Germany
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Regensburg, 93053
Bavaria
Germany
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Dresden, 01099
Sachsen
Germany
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Berlin Buch, 13125
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Germany
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Berlin, 10367
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Germany
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Berlin, 13353
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Germany
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Bielefeld, 33604
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Germany
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Bitburg, 54634
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Germany
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Dessau-Roßlau, 06846
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Germany
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Dresden, 01277
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Germany
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Elsterwerda, 04910
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Germany
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Frankfurt, 60594
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Germany
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Koeln, 50937
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Germany
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Koeln, 51065
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Germany
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Ulm, 89077
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Germany
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Wuerzburg, 97080
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Germany
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Wuppertal, 42109
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Germany
Italy
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Ancona, 60128
AN
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Bergamo, 24127
BG
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Cona, 44100
FE
Italy
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Firenze, 50134
FI
Italy
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Pozzilli, 86077
IS
Italy
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Rozzano, 20089
MI
Italy
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Modena, 41100
MO
Italy
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Pisa, 56124
PI
Italy
Korea, Republic of
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Wonju, 26426
Gangwon-Do
Korea, Republic of
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Seongnam Si, 13620
Gyeonggi Do
Korea, Republic of
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Seoul, 03080
Korea
Korea, Republic of
Lithuania
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Kaunas, LT 50161
LTU
Lithuania
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Vilnius, LT-08661
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Lithuania
Netherlands
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Amsterdam, 1081 HV
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Netherlands
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Hertogenbosch, 5200
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Netherlands
Poland
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Lodz, 90 549
Lodzkie
Poland
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Tarnow, 33-100
Malopolskie
Poland
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Krakow, 31271
Maloposkie
Poland
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Bialystok, 15 276
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Poland
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Katowice, 40-645
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Poland
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Krakow, 31 202
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Poland
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Warszawa, 02-097
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Poland
Russian Federation
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Moscow, 127644
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Russian Federation
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Saint Petersburg, 197022
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Russian Federation
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Saint Petersburg, 199106
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Russian Federation
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Saratov, 410012
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Russian Federation
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St Petersburg, 196601
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Russian Federation
Spain
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Valencia, 46010
Comunidad Valenciana
Spain
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San Sebastian de los Reyes, 28702
Madrid
Spain
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Madrid, 28034
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Spain
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Madrid, 28040
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Spain
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Madrid, 28041
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Spain
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Valencia, 46026
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Spain
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Zaragoza, 50009
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Spain
Switzerland
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Basel, 4031
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Switzerland
Taiwan
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Tainan, 70403
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Taiwan
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Taipei, 10002
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Taiwan
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Taipei, 11217
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Taiwan
Turkey
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Eskisehir, 26480
Meselik
Turkey
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Sivas, 58140
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Turkey
United Kingdom
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Plymouth, PL6 8BT
Devon
United Kingdom
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Axbridge, BS26 2BJ
Somerset
United Kingdom
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Cardiff, CF5 4AD
Wales
United Kingdom
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Birmingham, B16 8QQ
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United Kingdom
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Bournemouth, BH7 7DW
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United Kingdom
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East Yorkshire, HU16 5JQ
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United Kingdom
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Harrow, HA1 3UJ
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United Kingdom
Novartis Investigative Site
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Liverpool, L9 7AL
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United Kingdom
Novartis Investigative Site
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Newport, NP20 2UB
-
United Kingdom
Novartis Investigative Site
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Stevenage, SG1 4AB
-
United Kingdom

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