Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

Last updated: September 30, 2022
Sponsor: Lexicon Pharmaceuticals
Overall Status: Terminated

Phase

3

Condition

Diabetes Mellitus, Type 2

Hyponatremia

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT03521934
EFC15156
2017-003510-16
U1111-1190-7891
  • Ages 18-85
  • All Genders

Study Summary

Primary Objective:

To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF)

Secondary Objectives:

To compare the effects of sotagliflozin to placebo on:

  • The total occurrences of HHF and urgent visit for HF

  • The occurrence of CV death

  • The occurrence of all-cause mortality

  • The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke

  • Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score

  • Change in estimated glomerular filtration rate (eGFR)

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Type 2 Diabetes Mellitus.
  • Admitted to the hospital, or urgent heart failure visit for worsening heart failure.
  • Prior diagnosis of heart failure (> 3 months).
  • Prior chronic treatment for heart failure with a loop diuretic (eg furosemide,torsemide, bumetanide) for > 30 days.
  • Randomized when hemodynamically stable, prior to hospital discharge or within 3 daysof discharge.
  • Brain natriuretic peptide (BNP) ≥150 picograms per milliliter (pg/mL) (≥450 pg/mL forparticipants with atrial fibrillation) or N-terminal B-type natriuretic peptide ≥600pg/mL (≥1800 pg/mL for participants with atrial fibrillation).
  • Participants with Left Ventricular Ejection Fraction <40% should be on beta-blockersand renin-angiotensin-aldosterone system (RAAS) inhibitors as per local guidelinesunless contraindicated.
  • Signed written informed consent.

Exclusion

Exclusion criteria:

  • Age < 18 years or > 85 years.
  • Worsening heart failure attributed to other causes such as pulmonary embolism, stroke,heart attack.
  • Cardiac surgery or coronary procedure within 1 month or planned during study.
  • Lower extremity complications (such as skin ulcer, infection, osteomyelitis, andgangrene) identified during screening and requiring treatment at randomization.
  • Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during thestudy.
  • Acute coronary syndromes within 3 months prior to Randomization.
  • Hemodynamically significant uncorrected primary valvular disease.
  • Significant pulmonary disease contributing substantially to the participant's dyspnea.
  • End stage Heart Failure.
  • History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar coma within 3 monthsprior to screening.
  • History of stroke within 3 months prior to randomization.
  • History of dialysis within 1 year prior to randomization.
  • History of solid organ transplant or on a transplant list (if heart transplant,defined as status 1 transplant).
  • Severe kidney disease as defined by glomerular filtration rate (eGFR) <30 milliliterper minute per 1.72 meter square (mL/min/1.73 m^2).
  • Pregnancy. The above information is not intended to contain all considerations relevant to aparticipant's potential participation in a clinical trial.

Study Design

Total Participants: 1222
Study Start date:
June 15, 2018
Estimated Completion Date:
June 05, 2020

Study Description

The estimated study duration for a given participants will be approximately 3 to 24 months.

Connect with a study center

  • Investigational Site Number 0320009

    Caba, C1093AAS
    Argentina

    Site Not Available

  • Investigational Site Number 0320031

    Caba, 1430
    Argentina

    Site Not Available

  • Investigational Site Number 0320016

    Capital Federal, 1405
    Argentina

    Site Not Available

  • Investigational Site Number 0320002

    Ciudad De Buenos Aires, C1428DCO
    Argentina

    Site Not Available

  • Investigational Site Number 0320010

    Cordoba, X5004BAL
    Argentina

    Site Not Available

  • Investigational Site Number 0320011

    Cordoba, X5000AAX
    Argentina

    Site Not Available

  • Investigational Site Number 0320001

    Corrientes, W3400AMZ
    Argentina

    Site Not Available

  • Investigational Site Number 0320022

    Corrientes, 3400
    Argentina

    Site Not Available

  • Investigational Site Number 0320003

    Córdoba, X5000JHQ
    Argentina

    Site Not Available

  • Investigational Site Number 0320024

    Córdoba, 5000
    Argentina

    Site Not Available

  • Investigational Site Number 0320025

    Córdoba, X5006IKK
    Argentina

    Site Not Available

  • Investigational Site Number 0320007

    La Plata, B1906ESC
    Argentina

    Site Not Available

  • Investigational Site Number 0320029

    La Plata, B1900AXI
    Argentina

    Site Not Available

  • Investigational Site Number 0320006

    Merlo, B1722COV
    Argentina

    Site Not Available

  • Investigational Site Number 0320005

    Moron, B1708CGU
    Argentina

    Site Not Available

  • Investigational Site Number 0320012

    Olivos, 1638
    Argentina

    Site Not Available

  • Investigational Site Number 0320023

    Quilmes, 1878
    Argentina

    Site Not Available

  • Investigational Site Number 0320013

    Rosario, S2000DSR
    Argentina

    Site Not Available

  • Investigational Site Number 0320018

    Rosario, 2000
    Argentina

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  • Investigational Site Number 0320008

    Salta, 4400
    Argentina

    Site Not Available

  • Investigational Site Number 0320020

    San Martin, B1685CSQ
    Argentina

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  • Investigational Site Number 0320019

    San Miguel De Tucuman, T4000NIL
    Argentina

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  • Investigational Site Number 0320028

    San Miguel De Tucuman, T4000IFL
    Argentina

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    Santa Fe, S3000FWO
    Argentina

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    Santa Fe, S3000EOZ
    Argentina

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    Tucuman, T4000JCU
    Argentina

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    Villa Belgrano, X5021FPQ
    Argentina

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    Villa Maria, X5900JKA
    Argentina

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    Birtinya, 4575
    Australia

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    Elizabeth Vale, 5112
    Australia

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    Maroochydore, 4558
    Australia

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    Murdoch, 6150
    Australia

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    Redcliffe, 4020
    Australia

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    Wollongong, 2500
    Australia

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    Braunau, 5280
    Austria

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    Braunau Am Inn, 5280
    Austria

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    Feldkirch, 6800
    Austria

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    Graz, 8036
    Austria

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    Linz, 4010
    Austria

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    Salzburg, 5020
    Austria

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    Wien, 1160
    Austria

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    Wien, 1090
    Austria

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    Aalst, 9300
    Belgium

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    Gent, 9000
    Belgium

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    Kortrijk, 8500
    Belgium

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    Leuven, 3000
    Belgium

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    Liège, 4000
    Belgium

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    Mol, 2400
    Belgium

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    Mons, 7000
    Belgium

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    Roeselare, 8800
    Belgium

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    Belo Horizonte, 30110-908
    Brazil

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    Belo Horizonte, 30150-221
    Brazil

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    Blumenau, 89020-430
    Brazil

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    Brasilia, 70390-903
    Brazil

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    Campinas, 13060-080
    Brazil

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    Campinas, 13092-111
    Brazil

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    Fortaleza, 60840-285
    Brazil

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    Goiania, 74210050
    Brazil

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    Maringá, 87015-000
    Brazil

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    Passo Fundo, 99010-180
    Brazil

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    Porto Alegre, 90020-090
    Brazil

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    Porto Alegre, 90620-001
    Brazil

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    Porto Alegre, 91350-250
    Brazil

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    Porto Alegre, 90035 003
    Brazil

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    Porto Alegre, 90610-000
    Brazil

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    Recife, 52051-380
    Brazil

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    Sao Jose Do Rio Preto, 15090-000
    Brazil

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    Sao Paulo, 05403-000
    Brazil

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    Sao Paulo, 04012-909
    Brazil

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    Votuporanga, 15500-003
    Brazil

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    Cambridge, N1R 6V6
    Canada

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    Granby, J2G 1T7
    Canada

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    Halifax, B3H 3A7
    Canada

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    Montreal, H1T 1C8
    Canada

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    Montreal, H4A 3J1
    Canada

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    Montreal, H3G 1A4
    Canada

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    Ottawa, K1Y 4W7
    Canada

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    Peterborough, K9J 0B2
    Canada

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    Quebec, G1V 4G5
    Canada

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    Scarborough, M1B 4Z8
    Canada

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    Sherbrooke, J1G 2E8
    Canada

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    Toronto, M5G 2C4
    Canada

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  • Investigational Site Number 1240011

    Toronto, M5B 1W8
    Canada

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  • Investigational Site Number 1240009

    Trois-Rivières, G9A 5C5
    Canada

    Site Not Available

  • Investigational Site Number 1520009

    Concepción,
    Chile

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  • Investigational Site Number 1520003

    Santiago, 8380456
    Chile

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    Santiago,
    Chile

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    Santiago,
    Chile

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    Santiago, 8053095
    Chile

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    Santiago, 80004005
    Chile

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    Santiago,
    Chile

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    Santiago,
    Chile

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    Temuco,
    Chile

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  • Investigational Site Number 1520010

    Vina Del Mar,
    Chile

    Site Not Available

  • Investigational Site Number 1520001

    Viña Del Mar,
    Chile

    Site Not Available

  • Investigational Site Number 2030001

    Brno, 62500
    Czechia

    Site Not Available

  • Investigational Site Number 2030003

    Brno, 63600
    Czechia

    Site Not Available

  • Investigational Site Number 2030004

    Brno, 65691
    Czechia

    Site Not Available

  • Investigational Site Number 2030014

    Kolin 3, 28002
    Czechia

    Site Not Available

  • Investigational Site Number 2030010

    Kromeriz, 76701
    Czechia

    Site Not Available

  • Investigational Site Number 2030005

    Liberec, 46063
    Czechia

    Site Not Available

  • Investigational Site Number 2030013

    Mestec Kralove, 28903
    Czechia

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    Praha 10, 10100
    Czechia

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    Praha 2, 12808
    Czechia

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  • Investigational Site Number 2030017

    Praha 5, 15030
    Czechia

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  • Investigational Site Number 2030007

    Praha 5 - Motol, 15006
    Czechia

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  • Investigational Site Number 2030011

    Prerov, 75152
    Czechia

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  • Investigational Site Number 2030015

    Pribram I, 26101
    Czechia

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  • Investigational Site Number 2030006

    Slany, 27401
    Czechia

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  • Investigational Site Number 2080003

    Aarhus N, 8200
    Denmark

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  • Investigational Site Number 2080002

    Glostrup, 2600
    Denmark

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  • Investigational Site Number 2080001

    Herlev, 2730
    Denmark

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    København Nv, 2400
    Denmark

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    Ålborg, 9100
    Denmark

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  • Investigational Site Number 2460004

    Espoo, 02740
    Finland

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  • Investigational Site Number 2460001

    Helsinki, 00029 HUS
    Finland

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    Jyväskylä, 40620
    Finland

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    Oulu, 90220
    Finland

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  • Investigational Site Number 2460005

    Seinäjoki, 60220
    Finland

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  • Investigational Site Number 2500009

    Chambray Les Tours, 37170
    France

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    La Tronche, 38700
    France

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    Le Chesnay, 78150
    France

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    Le Coudray, 28360
    France

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    Lille, 59037
    France

    Site Not Available

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    Lille Cedex, 59037
    France

    Site Not Available

  • Investigational Site Number 2500007

    Nantes Cedex 1, 44093
    France

    Site Not Available

  • Investigational Site Number 2500012

    Nice Cedex 1, 06002
    France

    Site Not Available

  • Investigational Site Number 2500006

    Paris, 75015
    France

    Site Not Available

  • Investigational Site Number 2500003

    Paris Cedex 18, 75877
    France

    Site Not Available

  • Investigational Site Number 2500005

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Investigational Site Number 2500013

    Vandoeuvre-Les-Nancy, 54500
    France

    Site Not Available

  • Investigational Site Number 2500013

    Vandoeuvre-Les-Nancy Cedex, 54511
    France

    Site Not Available

  • Investigational Site Number 2760020

    Bad Nauheim, 61231
    Germany

    Site Not Available

  • Investigational Site Number 2760016

    Bad Oeynhausen, 32545
    Germany

    Site Not Available

  • Investigational Site Number 2760001

    Berlin, 13353
    Germany

    Site Not Available

  • Investigational Site Number 2760002

    Berlin, 13353
    Germany

    Site Not Available

  • Investigational Site Number 2760013

    Berlin, 12203
    Germany

    Site Not Available

  • Investigational Site Number 2760019

    Berlin, 13347
    Germany

    Site Not Available

  • Investigational Site Number 2760025

    Bielefeld, 33604
    Germany

    Site Not Available

  • Investigational Site Number 2760005

    Bonn, 53115
    Germany

    Site Not Available

  • Investigational Site Number 2760021

    Bremen, 28277
    Germany

    Site Not Available

  • Investigational Site Number 2760035

    Coburg, 96450
    Germany

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  • Investigational Site Number 2760006

    Dortmund, 44379
    Germany

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  • Investigational Site Number 2760032

    Dortmund, 44137
    Germany

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  • Investigational Site Number 2760029

    Erfurt, 99097
    Germany

    Site Not Available

  • Investigational Site Number 2760018

    Essen, 45138
    Germany

    Site Not Available

  • Investigational Site Number 2760033

    Frankfurt Am Main, 65929
    Germany

    Site Not Available

  • Investigational Site Number 2760009

    Greifswald, 17475
    Germany

    Site Not Available

  • Investigational Site Number 2760022

    Heidelberg, 69115
    Germany

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  • Investigational Site Number 2760031

    Heidelberg, 69120
    Germany

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  • Investigational Site Number 2760027

    Köln, 50733
    Germany

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  • Investigational Site Number 2760034

    Lahr, 77933
    Germany

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    Langen, 63225
    Germany

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    Leverkusen, 51375
    Germany

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    Limburg, 65549
    Germany

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    Ludwigshafen, 67063
    Germany

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    Merseburg, 06217
    Germany

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    Rotenburg An Der Fulda, 36199
    Germany

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    Rüsselsheim, 65428
    Germany

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    Witten, 58455
    Germany

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    Würzburg, 97080
    Germany

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    Athens, 11527
    Greece

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    Athens, 11526
    Greece

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    Chalkida, 34 100
    Greece

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    Chaïdári, 12462
    Greece

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    Elefsina, 19600
    Greece

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    Haidari, 12462
    Greece

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    Heraklion, 71110
    Greece

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    Ioannina, 455 00
    Greece

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    Larissa, 41110
    Greece

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    N. Ionia, 14233
    Greece

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    Thessaloniki, 546 36
    Greece

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    Berettyóújfalu, 4100
    Hungary

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    Budapest, 1122
    Hungary

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    Budapest, 1204
    Hungary

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    Budapest, 1096
    Hungary

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    Budapest, 1134
    Hungary

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    Budapest, 1023
    Hungary

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    Budapest, 1145
    Hungary

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    Budapest, 1125
    Hungary

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    Budapest, 1085
    Hungary

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    Budapest, 1115
    Hungary

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    Cegled, 2700
    Hungary

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    Cegléd,
    Hungary

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    Debrecen, 4032
    Hungary

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    Dombóvár, 7200
    Hungary

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    Gyula, 5700
    Hungary

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    Hódmezövásárhely, 6800
    Hungary

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    Kistarcsa, 2143
    Hungary

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    Komárom, 2921
    Hungary

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    Pécs, 7624
    Hungary

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    Szekesfehervar, 8000
    Hungary

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    Zalaegerszeg, 8900
    Hungary

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    Ashkelon, 78278
    Israel

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    Hadera, 38100
    Israel

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    Haifa, 31096
    Israel

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    Jerusalem, 91120
    Israel

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    Jerusalem, 91031
    Israel

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    Jerusalem,
    Israel

    Site Not Available

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    Nahariya, 22100
    Israel

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    Petah-Tikva, 49100
    Israel

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    Rehovot, 76100
    Israel

    Site Not Available

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    Safed, 13100
    Israel

    Site Not Available

  • Investigational Site Number 3760001

    Tel Aviv, 64239
    Israel

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    Tel Hashomer, 52621
    Israel

    Site Not Available

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    Tiberias, 15208
    Israel

    Site Not Available

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    Arzignano (Vi), 36071
    Italy

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    Brescia, 25123
    Italy

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    Brescia, 25124
    Italy

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    Cortona, 52044
    Italy

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    Ferrara, 44124
    Italy

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    Gallipoli, 73014
    Italy

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    Legnago, 37045
    Italy

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    Milano, 20138
    Italy

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    Milano, 20162
    Italy

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    Milano, 20138
    Italy

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    Milano, 20122
    Italy

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    Monza, 20052
    Italy

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    Napoli, 80131
    Italy

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    Pavia, 27100
    Italy

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    Perugia, 06132
    Italy

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    Pozzilli, 86077
    Italy

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    Rimini, 47900
    Italy

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    Roma, 00153
    Italy

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    Roma, 00189
    Italy

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    Scorrano, 73020
    Italy

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    Udine, 33100
    Italy

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    Bucheon-Si, 14754
    Korea, Republic of

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    Busan, 49267
    Korea, Republic of

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  • Investigational Site Number 4100004

    Daegu, 42472
    Korea, Republic of

    Site Not Available

  • Investigational Site Number 4100001

    Hwaseong-Si, 18450
    Korea, Republic of

    Site Not Available

  • Investigational Site Number 4100003

    Incheon, 22332
    Korea, Republic of

    Site Not Available

  • Investigational Site Number 4100005

    Seongnam-Si, 13620
    Korea, Republic of

    Site Not Available

  • Investigational Site Number 4100002

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Investigational Site Number 4100007

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Investigational Site Number 4100009

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Investigational Site Number 4100011

    Seoul, 05030
    Korea, Republic of

    Site Not Available

  • Investigational Site Number 4280004

    Daugavpils, LV-5417
    Latvia

    Site Not Available

  • Investigational Site Number 4280002

    Liepaja, LV-3414
    Latvia

    Site Not Available

  • Investigational Site Number 4280001

    Riga, LV-1002
    Latvia

    Site Not Available

  • Investigational Site Number 4280003

    Riga, LV-1038
    Latvia

    Site Not Available

  • Investigational Site Number 4400002

    Kaunas, 50161
    Lithuania

    Site Not Available

  • Investigational Site Number 4400005

    Kaunas, 50161
    Lithuania

    Site Not Available

  • Investigational Site Number 4400004

    Klaipeda, LT-92288
    Lithuania

    Site Not Available

  • Investigational Site Number 4400006

    Siauliai, LT-76231
    Lithuania

    Site Not Available

  • Investigational Site Number 4400001

    Vilnius, 08661
    Lithuania

    Site Not Available

  • Investigational Site Number 4400003

    Vilnius, 08661
    Lithuania

    Site Not Available

  • Investigational Site Number 5280003

    Amsterdam, 1034 CS
    Netherlands

    Site Not Available

  • Investigational Site Number 5280001

    Breda, 4819 EV
    Netherlands

    Site Not Available

  • Investigational Site Number 5280007

    Delft, 2625 AD
    Netherlands

    Site Not Available

  • Investigational Site Number 5280002

    Doetinchem, 7009 BL
    Netherlands

    Site Not Available

  • Investigational Site Number 5280004

    Hertogenbosch, 5223 GZ 's
    Netherlands

    Site Not Available

  • Investigational Site Number 5280006

    Rotterdam, 3045 PM
    Netherlands

    Site Not Available

  • Investigational Site Number 5280008

    Sneek, 8601
    Netherlands

    Site Not Available

  • Investigational Site Number 5280005

    Veldhoven, 5504 DB
    Netherlands

    Site Not Available

  • Investigational Site Number 5540007

    Auckland, 1023
    New Zealand

    Site Not Available

  • Investigational Site Number 5540006

    Christchurch, 8011
    New Zealand

    Site Not Available

  • Investigational Site Number 5540002

    Hamilton, 3204
    New Zealand

    Site Not Available

  • Investigational Site Number 5540004

    Lower Hutt,
    New Zealand

    Site Not Available

  • Investigational Site Number 5540005

    New Plymouth,
    New Zealand

    Site Not Available

  • Investigational Site Number 5540003

    Rotorua, 3010
    New Zealand

    Site Not Available

  • Investigational Site Number 6160007

    Bialystok, 15-276
    Poland

    Site Not Available

  • Investigational Site Number 6160017

    Gdansk, 80-462
    Poland

    Site Not Available

  • Investigational Site Number 6160002

    Grodzisk Mazowiecki, 05-825
    Poland

    Site Not Available

  • Investigational Site Number 6160014

    Katowice, 40-635
    Poland

    Site Not Available

  • Investigational Site Number 6160001

    Krakow, 31 -202
    Poland

    Site Not Available

  • Investigational Site Number 6160003

    Krakow, 31-501
    Poland

    Site Not Available

  • Investigational Site Number 6160012

    Krakow,
    Poland

    Site Not Available

  • Investigational Site Number 6160021

    Krakow, 30-693
    Poland

    Site Not Available

  • Investigational Site Number 6160011

    Leczna, 21-010
    Poland

    Site Not Available

  • Investigational Site Number 6160016

    Lubin, 59-301
    Poland

    Site Not Available

  • Investigational Site Number 6160005

    Miechow, 32-200
    Poland

    Site Not Available

  • Investigational Site Number 6160022

    Poznan, 61-848
    Poland

    Site Not Available

  • Investigational Site Number 6160006

    Torun, 87-100
    Poland

    Site Not Available

  • Investigational Site Number 6160004

    Warszawa, 03-242
    Poland

    Site Not Available

  • Investigational Site Number 6160008

    Warszawa, 04-628
    Poland

    Site Not Available

  • Investigational Site Number 6160013

    Warszawa, 00-685
    Poland

    Site Not Available

  • Investigational Site Number 6160020

    Warszawa, 04-073
    Poland

    Site Not Available

  • Investigational Site Number 6160024

    Warszawa, 04-349
    Poland

    Site Not Available

  • Investigational Site Number 6160015

    Zamosc, 22-400
    Poland

    Site Not Available

  • Investigational Site Number 6200012

    Braga, 4710-243
    Portugal

    Site Not Available

  • Investigational Site Number 6200001

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • Investigational Site Number 6200011

    Guilhufe, 4564-007
    Portugal

    Site Not Available

  • Investigational Site Number 6200011

    Guilhufe - Penafiel, 4564-007
    Portugal

    Site Not Available

  • Investigational Site Number 6200004

    Guimarães, 4810-061
    Portugal

    Site Not Available

  • Investigational Site Number 6200002

    Lisboa, 1500-650
    Portugal

    Site Not Available

  • Investigational Site Number 6200006

    Lisboa, 1449-005
    Portugal

    Site Not Available

  • Investigational Site Number 6200008

    Porto, 4099-001
    Portugal

    Site Not Available

  • Investigational Site Number 6200007

    Vila Franca De Xira, 2600-009
    Portugal

    Site Not Available

  • Investigational Site Number 6200003

    Vila Nova De Gaia, 4434-502
    Portugal

    Site Not Available

  • Investigational Site Number 6200003

    Vila Nova Gaia, 4434-502
    Portugal

    Site Not Available

  • Investigational Site Number 6200005

    Vila Real, 5000-508
    Portugal

    Site Not Available

  • Investigational Site Number 6420014

    Arad, 310037
    Romania

    Site Not Available

  • Investigational Site Number 6420006

    Baia Mare, 430031
    Romania

    Site Not Available

  • Investigational Site Number 6420015

    Braila, 810325
    Romania

    Site Not Available

  • Investigational Site Number 6420013

    Bucharest, 010825
    Romania

    Site Not Available

  • Investigational Site Number 6420007

    Bucuresti, 050659
    Romania

    Site Not Available

  • Investigational Site Number 6420008

    Bucuresti, 022322
    Romania

    Site Not Available

  • Investigational Site Number 6420011

    Bucuresti, 020125
    Romania

    Site Not Available

  • Investigational Site Number 6420019

    Bucuresti, 014461
    Romania

    Site Not Available

  • Investigational Site Number 6420002

    Cluj Napoca, 400001
    Romania

    Site Not Available

  • Investigational Site Number 6420003

    Cluj Napoca, 400347
    Romania

    Site Not Available

  • Investigational Site Number 6420016

    Craiova, 200642
    Romania

    Site Not Available

  • Investigational Site Number 6420004

    Oradea, 410469
    Romania

    Site Not Available

  • Investigational Site Number 6420005

    Oradea, 410169
    Romania

    Site Not Available

  • Investigational Site Number 6420018

    Satu Mare, 440156
    Romania

    Site Not Available

  • Investigational Site Number 6420001

    Targu Mures, 540103
    Romania

    Site Not Available

  • Investigational Site Number 6420012

    Tg-Mures, 540136
    Romania

    Site Not Available

  • Investigational Site Number 6420009

    Timisoara, 300079
    Romania

    Site Not Available

  • Investigational Site Number 6420010

    Timisoara, 300723
    Romania

    Site Not Available

  • Investigational Site Number 6430026

    Ivanovo, 153012
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430023

    Kazan, 420087
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430002

    Kemerovo, 650002
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430006

    Kemerovo, 650002
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430001

    Moscow, 121552
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430003

    Moscow, 121552
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430004

    Moscow, 111539
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430005

    Moscow, 109240
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430010

    Moscow, 121552
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430022

    Moscow, 117292
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430024

    Moscow, 119192
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430018

    Nizhniy Novgorod, 603005
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430013

    Rostov-Na-Donu, 344068
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430011

    Saint-Petersburg, 198205
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430017

    Sochi, 354057
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430007

    St-Petersburg, 195067
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430009

    St-Petersburg, 199106
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430012

    St-Petersburg, 197341
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430025

    St-Petersburg, 193312
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430016

    Tomsk, 634012
    Russian Federation

    Site Not Available

  • Investigational Site Number 6430019

    Tyumen, 625000
    Russian Federation

    Site Not Available

  • Investigational Site Number 7030007

    Banska Bystrica, 97401
    Slovakia

    Site Not Available

  • Investigational Site Number 7030001

    Bratislava, 813 69
    Slovakia

    Site Not Available

  • Investigational Site Number 7030003

    Bratislava 3 - Kramare, 833 05
    Slovakia

    Site Not Available

  • Investigational Site Number 7030004

    Bratislava 37, 833 48
    Slovakia

    Site Not Available

  • Investigational Site Number 7030010

    Brezno, 97742
    Slovakia

    Site Not Available

  • Investigational Site Number 7030009

    Dolny Kubin, 02614
    Slovakia

    Site Not Available

  • Investigational Site Number 7030002

    Kosice, 040 01
    Slovakia

    Site Not Available

  • Investigational Site Number 7030011

    Nitra, 950 01
    Slovakia

    Site Not Available

  • Investigational Site Number 7030008

    Trnava, 91775
    Slovakia

    Site Not Available

  • Investigational Site Number 7240016

    Alicante, 03010
    Spain

    Site Not Available

  • Investigational Site Number 7240015

    Badalona, 08916
    Spain

    Site Not Available

  • Investigational Site Number 7240020

    Hospitalet De Llobregat, 08907
    Spain

    Site Not Available

  • Investigational Site Number 7240006

    La Coruña, 15006
    Spain

    Site Not Available

  • Investigational Site Number 7240005

    Las Palmas De Gran Canaria, 35020
    Spain

    Site Not Available

  • Investigational Site Number 7240008

    Madrid, 28040
    Spain

    Site Not Available

  • Investigational Site Number 7240021

    Madrid, 28031
    Spain

    Site Not Available

  • Investigational Site Number 7240017

    Majadahonda, 28222
    Spain

    Site Not Available

  • Investigational Site Number 7240022

    Manises, 46940
    Spain

    Site Not Available

  • Investigational Site Number 7240007

    Murcia, 30120
    Spain

    Site Not Available

  • Investigational Site Number 7240004

    Málaga, 29010
    Spain

    Site Not Available

  • Investigational Site Number 7240014

    Olot, 17800
    Spain

    Site Not Available

  • Investigational Site Number 7240009

    San Sebastián De Los Reyes, 28702
    Spain

    Site Not Available

  • Investigational Site Number 7240003

    Sanlúcar De Barrameda, 11540
    Spain

    Site Not Available

  • Investigational Site Number 7240001

    Sevilla, 41014
    Spain

    Site Not Available

  • Investigational Site Number 7240019

    Sevilla, 41071
    Spain

    Site Not Available

  • Investigational Site Number 7240010

    Valencia, 46026
    Spain

    Site Not Available

  • Investigational Site Number 7240011

    Valencia, 46014
    Spain

    Site Not Available

  • Investigational Site Number 7240012

    Valencia, 46010
    Spain

    Site Not Available

  • Investigational Site Number 7240002

    Villamartín, 11650
    Spain

    Site Not Available

  • Investigational Site Number 7240013

    Zaragoza, 50009
    Spain

    Site Not Available

  • Investigational Site Number 7240018

    Úbeda, 23400
    Spain

    Site Not Available

  • Investigational Site Number 7520004

    Jönköping, 551 85
    Sweden

    Site Not Available

  • Investigational Site Number 7520002

    Malmö, 205 02
    Sweden

    Site Not Available

  • Investigational Site Number 7520006

    Skellefteå, 931 86
    Sweden

    Site Not Available

  • Investigational Site Number 7520001

    Stockholm, 171 76
    Sweden

    Site Not Available

  • Investigational Site Number 7520007

    Stockholm, 118 83
    Sweden

    Site Not Available

  • Investigational Site Number 7520008

    Stockholm, 14186
    Sweden

    Site Not Available

  • Investigational Site Number 7560001

    Basel, 4031
    Switzerland

    Site Not Available

  • Investigational Site Number 7560003

    Lugano, 6900
    Switzerland

    Site Not Available

  • Investigational Site Number 7920008

    Antalya, 07059
    Turkey

    Site Not Available

  • Investigational Site Number 7920006

    Corum, 19200
    Turkey

    Site Not Available

  • Investigational Site Number 7920005

    Eskisehir, 26480
    Turkey

    Site Not Available

  • Investigational Site Number 7920002

    Haseki/ Istanbul, 34034
    Turkey

    Site Not Available

  • Investigational Site Number 7920011

    Istanbul, 34098
    Turkey

    Site Not Available

  • Investigational Site Number 7920012

    Izmir, 35340
    Turkey

    Site Not Available

  • Investigational Site Number 7920003

    Kocaeli, 41300
    Turkey

    Site Not Available

  • Investigational Site Number 7920004

    Mersin, 33169
    Turkey

    Site Not Available

  • Investigational Site Number 7920001

    Sivas, 58140
    Turkey

    Site Not Available

  • Investigational Site Number 7920010

    Trabzon, 61040
    Turkey

    Site Not Available

  • Investigational Site Number 8260005

    Bournemouth, BH7 7DW
    United Kingdom

    Site Not Available

  • Investigational Site Number 8260010

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Investigational Site Number 8260008

    Chelmsford, CM1 7ET
    United Kingdom

    Site Not Available

  • Investigational Site Number 8260009

    Hull, HU16 5JQ
    United Kingdom

    Site Not Available

  • Investigational Site Number 8260002

    Newcastle, NE1 4LP
    United Kingdom

    Site Not Available

  • Investigational Site Number 8260001

    Oldham, OL1 2JH
    United Kingdom

    Site Not Available

  • Investigational Site Number 8260003

    Swansea, SA6 6NL
    United Kingdom

    Site Not Available

  • Investigational Site Number 8260006

    Swindon, SN3 6BB
    United Kingdom

    Site Not Available

  • Investigational Site Number 8260004

    Torquay, TQ2 7AA
    United Kingdom

    Site Not Available

  • Investigational Site Number 8260007

    York, YO31 8HE
    United Kingdom

    Site Not Available

  • Investigational Site Number 8400128

    Alexander City, Alabama 35010
    United States

    Site Not Available

  • Investigational Site Number 8400109

    Cottonwood, Arizona 86326
    United States

    Site Not Available

  • Investigational Site Number 8400032

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Investigational Site Number 8400080

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Investigational Site Number 8400075

    Bakersfield, California 93309
    United States

    Site Not Available

  • Investigational Site Number 8400069

    Fresno, California 93701
    United States

    Site Not Available

  • Investigational Site Number 8400008

    Los Angeles, California 90024
    United States

    Site Not Available

  • Investigational Site Number 8400063

    Los Angeles, California 90073
    United States

    Site Not Available

  • Investigational Site Number 8400127

    National City, California 91950
    United States

    Site Not Available

  • Investigational Site Number 8400007

    Redondo Beach, California 90277
    United States

    Site Not Available

  • Investigational Site Number 8400036

    Stockton, California 95204
    United States

    Site Not Available

  • Investigational Site Number 8400033

    Sylmar, California 91342
    United States

    Site Not Available

  • Investigational Site Number 8400049

    Torrance, California 90502
    United States

    Site Not Available

  • Investigational Site Number 8400028

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Investigational Site Number 8400029

    Bridgeport, Connecticut 06606
    United States

    Site Not Available

  • Investigational Site Number 8400086

    Hartford, Connecticut 06102
    United States

    Site Not Available

  • Investigational Site Number 8400037

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Investigational Site Number 8400046

    DeLand, Florida 32720
    United States

    Site Not Available

  • Investigational Site Number 8400009

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Investigational Site Number 8400079

    Homestead, Florida 33033
    United States

    Site Not Available

  • Investigational Site Number 8400022

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Investigational Site Number 8400031

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Investigational Site Number 8400098

    Lake Mary, Florida 32746
    United States

    Site Not Available

  • Investigational Site Number 8400064

    Miami, Florida 33173
    United States

    Site Not Available

  • Investigational Site Number 8400058

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Investigational Site Number 8400105

    Orlando, Florida 32806
    United States

    Site Not Available

  • Investigational Site Number 8400082

    Pensacola, Florida 32504
    United States

    Site Not Available

  • Investigational Site Number 8400057

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Investigational Site Number 8400006

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Investigational Site Number 8400024

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Investigational Site Number 8400035

    Tampa, Florida 33609
    United States

    Site Not Available

  • Investigational Site Number 8400042

    Tampa, Florida 33612
    United States

    Site Not Available

  • Investigational Site Number 8400004

    Wellington, Florida 33449
    United States

    Site Not Available

  • Investigational Site Number 8400073

    Atlanta, Georgia 30322-1020
    United States

    Site Not Available

  • Investigational Site Number 8400118

    Tucker, Georgia 30084
    United States

    Site Not Available

  • Investigational Site Number 8400067

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Investigational Site Number 8400043

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Investigational Site Number 8400072

    Elk Grove Village, Illinois 60007
    United States

    Site Not Available

  • Investigational Site Number 8400055

    Indianapolis, Indiana 46060
    United States

    Site Not Available

  • Investigational Site Number 8400020

    Muncie, Indiana 47303-3400
    United States

    Site Not Available

  • Investigational Site Number 8400122

    Richmond, Indiana 47374
    United States

    Site Not Available

  • Investigational Site Number 8400091

    Waterloo, Iowa 50702
    United States

    Site Not Available

  • Investigational Site Number 8400030

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Investigational Site Number 8400065

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Investigational Site Number 8400012

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Investigational Site Number 8400001

    Cambridge, Massachusetts 02135
    United States

    Site Not Available

  • Investigational Site Number 8400077

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Investigational Site Number 8400017

    Kalamazoo, Michigan 49048
    United States

    Site Not Available

  • Investigational Site Number 8400062

    Kalamazoo, Michigan 49009
    United States

    Site Not Available

  • Investigational Site Number 8400107

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Investigational Site Number 8400056

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Investigational Site Number 8400019

    Columbia, Missouri 65201
    United States

    Site Not Available

  • Investigational Site Number 8400103

    Lee's Summit, Missouri 64064
    United States

    Site Not Available

  • Investigational Site Number 8400132

    Grand Island, Nebraska 68803
    United States

    Site Not Available

  • Investigational Site Number 8400130

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Investigational Site Number 8400071

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Investigational Site Number 8400083

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • Investigational Site Number 8400015

    Ridgewood, New Jersey 07450-2736
    United States

    Site Not Available

  • Investigational Site Number 8400050

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Investigational Site Number 8400131

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Investigational Site Number 8400061

    Bronx, New York 10468-3904
    United States

    Site Not Available

  • Investigational Site Number 8400097

    Bronx, New York 10457
    United States

    Site Not Available

  • Investigational Site Number 8400051

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Investigational Site Number 8400111

    Buffalo, New York 14215
    United States

    Site Not Available

  • Investigational Site Number 8400045

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Investigational Site Number 8400085

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • Investigational Site Number 8400078

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Investigational Site Number 8400047

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Investigational Site Number 8400087

    Cincinnati, Ohio 45220
    United States

    Site Not Available

  • Investigational Site Number 8400084

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Investigational Site Number 8400095

    Maumee, Ohio 43537
    United States

    Site Not Available

  • Investigational Site Number 8400099

    Toledo, Ohio 43699
    United States

    Site Not Available

  • Investigational Site Number 8400121

    Zanesville, Ohio 43701
    United States

    Site Not Available

  • Investigational Site Number 8400014

    Oklahoma City, Oklahoma 73084
    United States

    Site Not Available

  • Investigational Site Number 8400054

    Arlington, Oregon 19001
    United States

    Site Not Available

  • Investigational Site Number 8400134

    Doylestown, Pennsylvania 18901
    United States

    Site Not Available

  • Investigational Site Number 8400044

    Natrona Heights, Pennsylvania 15065
    United States

    Site Not Available

  • Investigational Site Number 8400115

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Investigational Site Number 8400039

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Investigational Site Number 8400114

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Investigational Site Number 8400100

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Investigational Site Number 8400059

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Investigational Site Number 8400092

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Investigational Site Number 8400104

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Investigational Site Number 8400040

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Investigational Site Number 8400088

    Greenville, Tennessee 30000
    United States

    Site Not Available

  • Investigational Site Number 8400089

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • Investigational Site Number 8400053

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Investigational Site Number 8400041

    Brownsville, Texas 78521
    United States

    Site Not Available

  • Investigational Site Number 8400074

    Dallas, Texas 75226
    United States

    Site Not Available

  • Investigational Site Number 8400016

    Houston, Texas 77030
    United States

    Site Not Available

  • Investigational Site Number 8400123

    McKinney, Texas 75071
    United States

    Site Not Available

  • Investigational Site Number 8400101

    New Braunfels, Texas 78130
    United States

    Site Not Available

  • Investigational Site Number 8400066

    Victoria, Texas 77901
    United States

    Site Not Available

  • Investigational Site Number 8400093

    Manassas, Virginia 20109
    United States

    Site Not Available

  • Investigational Site Number 8400003

    Richmond, Virginia 23249-0001
    United States

    Site Not Available

  • Investigational Site Number 8400126

    Clarksburg, West Virginia 26301
    United States

    Site Not Available

  • Investigational Site Number 8400038

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • Investigational Site Number 8400048

    Manitowoc, Wisconsin 54220
    United States

    Site Not Available

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