MedPath

Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy

Phase 3
Completed
Conditions
Acute Coronary Syndrome
Interventions
Drug: Otamixaban
Drug: Placebo (for Otamixaban)
Drug: Placebo (for UFH)
Drug: UFH
Drug: Placebo (for Eptifibatide)
Drug: Eptifibatide
Registration Number
NCT01076764
Lead Sponsor
Sanofi
Brief Summary

Primary Objective:

* To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide

Secondary Objectives:

* To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide

* To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide

* To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide

* To document the safety of Otamixaban as compared to UFH + eptifibatide

* To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide

Detailed Description

Up to the interim analysis, patients are randomized to one of the Otamixaban arms or the control arm (UFH + Eptifibatide). Then after interim analysis, patients will be randomized to the continued Otamixaban arm (per Data Monitoring Committee (DMC) decision based on interim analysis results) or the control arm (UFH + Eptifibatide). Except the DMC, all participants will remain blinded to this decision until the end of study.

The total duration of the study period per subject will range between 30 days and 180 days. Study end date being the Day 30 visit of the last randomized patient, follow up will be until Day 180 or study end date whichever comes first.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
13220
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusionPlacebo (for UFH)From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide)
Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusionPlacebo (for Eptifibatide)From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide)
Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusionOtamixabanFrom randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide)
Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusionPlacebo (for UFH)From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide)
Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusionPlacebo (for Eptifibatide)From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide)
UFH + EptifibatideUFHFrom randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Placebo (for Otamixaban) * Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion)
Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusionOtamixabanFrom randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide)
UFH + EptifibatidePlacebo (for Otamixaban)From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Placebo (for Otamixaban) * Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion)
UFH + EptifibatideEptifibatideFrom randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Placebo (for Otamixaban) * Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion)
Primary Outcome Measures
NameTimeMethod
Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarctionfrom randomization (day 1) to day 7
Safety: Adjudicated Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor)from day 1 to day 7
Secondary Outcome Measures
NameTimeMethod
Adjudicated all-cause deathfrom day 1 to day 30
Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any strokefrom day 1 to day 7
Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarctionfrom day 1 to day 30
Adjudicated Procedural thrombotic complications during the index PCIduring index PCI

Trial Locations

Locations (607)

Investigational Site Number 840911

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Pittsburgh, Pennsylvania, United States

Investigational Site Number 032010

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Cordoba, Argentina

Investigational Site Number 032020

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Mendoza, Argentina

Investigational Site Number 032023

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Resistencia, Argentina

Investigational Site Number 032002

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Resistencia, Argentina

Investigational Site Number 032028

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Rosario, Argentina

Investigational Site Number 032025

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San Luis, Argentina

Investigational Site Number 032041

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Santa Fe, Argentina

Investigational Site Number 032006

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Santa Fe, Argentina

Investigational Site Number 040001

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Wien, Austria

Investigational Site Number 112004

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Gomel, Belarus

Investigational Site Number 112001

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Minsk, Belarus

Investigational Site Number 056001

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Bonheiden, Belgium

Investigational Site Number 724022

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Barcelona, Spain

Investigational Site Number 056008

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Leuven, Belgium

Investigational Site Number 100509

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Ruse, Bulgaria

Investigational Site Number 100510

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Sandanski, Bulgaria

Investigational Site Number 100502

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Sofia, Bulgaria

Investigational Site Number 100507

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Varna, Bulgaria

Investigational Site Number 100504

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Veliko Tarnovo, Bulgaria

Investigational Site Number 100506

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Yambol, Bulgaria

Investigational Site Number 152906

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Concepcion, Chile

Investigational Site Number 152016

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Valdivia, Chile

Investigational Site Number 152003

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Antofagasta, Chile

Investigational Site Number 152010

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Santiago, Chile

Investigational Site Number 203006

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Zlin, Czech Republic

Investigational Site Number 818501

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Cairo, Egypt

Investigational Site Number 818503

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Giza, Egypt

Investigational Site Number 818502

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Cairo, Egypt

Investigational Site Number 300003

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Melissia, Greece

Investigational Site Number 356032

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Mumbai, India

Investigational Site Number 300006

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Thessaloniki, Greece

Investigational Site Number 356035

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Nagpur, India

Investigational Site Number 356026

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New Delhi, India

Investigational Site Number 376007

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Safed, Israel

Investigational Site Number 376009

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Haifa, Israel

Investigational Site Number 376010

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Holon, Israel

Investigational Site Number 376002

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Jerusalem, Israel

Investigational Site Number 376012

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Tzrifin, Israel

Investigational Site Number 484019

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Merida, Mexico

Investigational Site Number 578903

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Arendal, Norway

Investigational Site Number 591502

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Panamá, Panama

Investigational Site Number 604017

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Lima, Peru

Investigational Site Number 616046

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Katowice, Poland

Investigational Site Number 616003

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Radom, Poland

Investigational Site Number 616034

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Klodzko, Poland

Investigational Site Number 616045

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Krakow, Poland

Investigational Site Number 616002

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Krakow, Poland

Investigational Site Number 616018

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Walbrzych, Poland

Investigational Site Number 616014

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Warszawa, Poland

Investigational Site Number 616001

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Warszawa, Poland

Investigational Site Number 620010

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Almada, Portugal

Investigational Site Number 620001

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Coimbra, Portugal

Investigational Site Number 642001

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Bucuresti, Romania

Investigational Site Number 642005

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Cluj Napoca, Romania

Investigational Site Number 616029

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Lodz, Poland

Investigational Site Number 616004

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Lomza, Poland

Investigational Site Number 616024

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Lubin, Poland

Investigational Site Number 840527

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Tupelo, Mississippi, United States

Investigational Site Number 840902

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St. Petersburg, Florida, United States

Investigational Site Number 616041

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Lublin, Poland

Investigational Site Number 616020

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Zamosc, Poland

Investigational Site Number 620003

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Lisboa, Portugal

Investigational Site Number 620002

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Coimbra, Portugal

Investigational Site Number 642004

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Bucuresti, Romania

Investigational Site Number 643018

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Barnaul, Russian Federation

Investigational Site Number 643015

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Ekaterinburg, Russian Federation

Investigational Site Number 688502

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Sremska Kamenica, Serbia

Investigational Site Number 703002

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Martin, Slovakia

Investigational Site Number 703001

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Nitra, Slovakia

Investigational Site Number 688504

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Zemun, Serbia

Investigational Site Number 158008

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Taichung, Taiwan

Investigational Site Number 764005

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Bangkok, Thailand

Investigational Site Number 764006

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Rajathavee, Thailand

Investigational Site Number 158904

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Taipei, Taiwan

Investigational Site Number 764903

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Muang, Thailand

Investigational Site Number 788006

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Monastir, Tunisia

Investigational Site Number 788005

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Monastir, Tunisia

Investigational Site Number 788004

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Tunis, Tunisia

Investigational Site Number 804004

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Cherkasy, Ukraine

Investigational Site Number 704006

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Hanoi, Vietnam

Investigational Site Number 804003

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Zaporozhie, Ukraine

Investigational Site Number 356010

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Pune, India

Investigational Site Number 840207

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Houston, Texas, United States

Investigational Site Number 840559

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Houston, Texas, United States

Investigational Site Number 840586

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Houston, Texas, United States

Investigational Site Number 840510

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Minneapolis, Minnesota, United States

Investigational Site Number 840525

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Minneapolis, Minnesota, United States

Investigational Site Number 764007

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Klong Luang, Thailand

Investigational Site Number 840569

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Phoenix, Arizona, United States

Investigational Site Number 840703

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Phoenix, Arizona, United States

Investigational Site Number 840065

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San Francisco, California, United States

Investigational Site Number 840049

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Oklahoma City, Oklahoma, United States

Investigational Site Number 840905

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Oklahoma City, Oklahoma, United States

Investigational Site Number 840047

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Lake Mary, Florida, United States

Investigational Site Number 840009

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Ocala, Florida, United States

Investigational Site Number 840706

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Miami, Florida, United States

Investigational Site Number 840028

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Jacksonville, Florida, United States

Investigational Site Number 840557

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Los Angeles, California, United States

Investigational Site Number 840560

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Muncie, Indiana, United States

Investigational Site Number 840904

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Ames, Iowa, United States

Investigational Site Number 840912

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Overland, Kansas, United States

Investigational Site Number 840071

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Los Angeles, California, United States

Investigational Site Number 840101

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Anaheim, California, United States

Investigational Site Number 840015

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Huntsville, Alabama, United States

Investigational Site Number 840213

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Beverley Hills, California, United States

Investigational Site Number 840151

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Anaheim, California, United States

Investigational Site Number 840572

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Huntington Beach, California, United States

Investigational Site Number 840551

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Bridgeport, Connecticut, United States

Investigational Site Number 840561

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Santa Rosa, California, United States

Investigational Site Number 840531

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Saginaw, Michigan, United States

Investigational Site Number 840554

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Indianapolis, Indiana, United States

Investigational Site Number 840146

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Ocala, Florida, United States

Investigational Site Number 840209

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Independence, Missouri, United States

Investigational Site Number 840517

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Dearborn, Michigan, United States

Investigational Site Number 840042

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Hammond, Indiana, United States

Investigational Site Number 840058

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West Des Moines, Iowa, United States

Investigational Site Number 840719

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Gainesville, Georgia, United States

Investigational Site Number 840190

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Chicago, Illinois, United States

Investigational Site Number 840208

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Bridgeton, Missouri, United States

Investigational Site Number 840530

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St Louis, Missouri, United States

Investigational Site Number 840580

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St Louis, Missouri, United States

Investigational Site Number 840585

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Charlotte, North Carolina, United States

Investigational Site Number 840518

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Brooklyn, New York, United States

Investigational Site Number 840136

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Minot, North Dakota, United States

Investigational Site Number 840206

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Eugene, Oregon, United States

Investigational Site Number 840082

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Toledo, Ohio, United States

Investigational Site Number 840003

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Erie, Pennsylvania, United States

Investigational Site Number 840025

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Midwest City, Oklahoma, United States

Investigational Site Number 840098

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Harrisburg, Pennsylvania, United States

Investigational Site Number 840573

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Philadelphia, Pennsylvania, United States

Investigational Site Number 840901

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Tulsa, Oklahoma, United States

Investigational Site Number 840060

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Dallas, Texas, United States

Investigational Site Number 840023

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Amarillo, Texas, United States

Investigational Site Number 840578

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Dallas, Texas, United States

Investigational Site Number 840090

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Houston, Texas, United States

Investigational Site Number 032014

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Caba, Argentina

Investigational Site Number 840555

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Wichita Falls, Texas, United States

Investigational Site Number 840087

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Tyler, Texas, United States

Investigational Site Number 032039

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Capital Federal, Argentina

Investigational Site Number 032045

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Capital Federal, Argentina

Investigational Site Number 032029

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Ciudad Autonoma De Bs.As, Argentina

Investigational Site Number 840165

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Salem, Virginia, United States

Investigational Site Number 032003

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Buenos Aires, Argentina

Investigational Site Number 840565

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Winchester, Virginia, United States

Investigational Site Number 032043

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Buenos Aires, Argentina

Investigational Site Number 032007

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Capital Federal, Argentina

Investigational Site Number 032004

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Rosario, Argentina

Investigational Site Number 032036

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Ciudad De Buenos Aires, Argentina

Investigational Site Number 032044

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Cordoba, Argentina

Investigational Site Number 032001

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Corrientes, Argentina

Investigational Site Number 032035

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Florencio Varela, Argentina

Investigational Site Number 032018

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La Plata, Argentina

Investigational Site Number 032022

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Pilar, Argentina

Investigational Site Number 036001

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Herston, Australia

Investigational Site Number 032008

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San Miguel De Tucuman, Argentina

Investigational Site Number 112003

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Minsk, Belarus

Investigational Site Number 100508

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Kazanlak, Bulgaria

Investigational Site Number 076013

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Passo Fundo, Brazil

Investigational Site Number 036003

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Prahran, Australia

Investigational Site Number 036008

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Adelaide, Australia

Investigational Site Number 036913

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Hobart, Australia

Investigational Site Number 036011

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Liverpool, Australia

Investigational Site Number 036004

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Ballarat, Australia

Investigational Site Number 040002

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Wien, Austria

Investigational Site Number 076016

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Maringa, Brazil

Investigational Site Number 036010

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Concord, Australia

Investigational Site Number 112002

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Minsk, Belarus

Investigational Site Number 076025

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Campinas, Brazil

Investigational Site Number 056007

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Brugge, Belgium

Investigational Site Number 056003

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Brussels, Belgium

Investigational Site Number 100505

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Pleven, Bulgaria

Investigational Site Number 124005

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Gatineau, Canada

Investigational Site Number 124004

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Montreal, Canada

Investigational Site Number 152005

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Iquique, Chile

Investigational Site Number 152902

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Santiago, Chile

Investigational Site Number 124007

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Sherbrooke, Canada

Investigational Site Number 124009

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St. John, Canada

Investigational Site Number 152012

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Santiago, Chile

Investigational Site Number 170002

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Bucaramanga, Colombia

Investigational Site Number 152912

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Valparaíso, Chile

Investigational Site Number 152910

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Viña Del Mar, Chile

Investigational Site Number 170016

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Barranquilla, Colombia

Investigational Site Number 191503

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Zagreb, Croatia

Investigational Site Number 191506

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Zagreb, Croatia

Investigational Site Number 191505

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Zagreb, Croatia

Investigational Site Number 818504

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Cairo, Egypt

Investigational Site Number 233001

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Tallinn, Estonia

Investigational Site Number 250010

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Bayonne, France

Investigational Site Number 233901

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Tallinn, Estonia

Investigational Site Number 250003

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Dijon Cedex, France

Investigational Site Number 250015

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Mulhouse, France

Investigational Site Number 276022

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Berlin, Germany

Investigational Site Number 250013

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Le Chesnay Cedex, France

Investigational Site Number 250009

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Paris, France

Investigational Site Number 276024

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Berlin, Germany

Investigational Site Number 250007

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Rouen, France

Investigational Site Number 276004

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Berlin, Germany

Investigational Site Number 276023

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Bonn, Germany

Investigational Site Number 276901

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Freiburg, Germany

Investigational Site Number 276003

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Hamburg, Germany

Investigational Site Number 276904

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Heidenheim, Germany

Investigational Site Number 276009

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Heidelberg, Germany

Investigational Site Number 276005

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München, Germany

Investigational Site Number 276905

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Mönchengladbach, Germany

Investigational Site Number 300009

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Alexandroupolis, Greece

Investigational Site Number 300004

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Athens, Greece

Investigational Site Number 300007

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Chios, Greece

Investigational Site Number 348005

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Szombathely, Hungary

Investigational Site Number 348008

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Budapest, Hungary

Investigational Site Number 356019

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Ahmedabad, India

Investigational Site Number 356004

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Ahmedabad, India

Investigational Site Number 356040

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Hyderabad, India

Investigational Site Number 356014

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Jaipur, India

Investigational Site Number 356039

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Madurai, India

Investigational Site Number 356003

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Karamsad, India

Investigational Site Number 356031

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Mumbai, India

Investigational Site Number 356036

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Nashik, India

Investigational Site Number 376008

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Tel Aviv, Israel

Investigational Site Number 376001

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Tel Hashomer, Israel

Investigational Site Number 380902

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Bergamo, Italy

Investigational Site Number 360505

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Bandung, Indonesia

Investigational Site Number 410004

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Goyang, Korea, Republic of

Investigational Site Number 360503

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Jakarta, Indonesia

Investigational Site Number 380929

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Castellanza, Italy

Investigational Site Number 380918

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Bologna, Italy

Investigational Site Number 376003

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Ashkelon, Israel

Investigational Site Number 380926

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Conegliano, Italy

Investigational Site Number 360502

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Jakarta, Indonesia

Investigational Site Number 380933

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Messina, Italy

Investigational Site Number 380927

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Rovigo, Italy

Investigational Site Number 400501

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Amman, Jordan

Investigational Site Number 428001

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Riga, Latvia

Investigational Site Number 440003

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Kaunas, Lithuania

Investigational Site Number 410014

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Daegu, Korea, Republic of

Investigational Site Number 400502

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Irbid, Jordan

Investigational Site Number 410018

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Guri, Korea, Republic of

Investigational Site Number 410005

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Busan, Korea, Republic of

Investigational Site Number 410006

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Busan, Korea, Republic of

Investigational Site Number 410007

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Seongnam, Korea, Republic of

Investigational Site Number 410012

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Seoul, Korea, Republic of

Investigational Site Number 410016

🇰🇷

Gwangju, Korea, Republic of

Investigational Site Number 528003

🇳🇱

Alkmaar, Netherlands

Investigational Site Number 604005

🇵🇪

Lambayeque, Peru

Investigational Site Number 458001

🇲🇾

Kuching, Malaysia

Investigational Site Number 484911

🇲🇽

San Luis Potosi, Mexico

Investigational Site Number 554004

🇳🇿

Auckland, New Zealand

Investigational Site Number 410008

🇰🇷

Seoul, Korea, Republic of

Investigational Site Number 410001

🇰🇷

Seoul, Korea, Republic of

Investigational Site Number 428002

🇱🇻

Liepaja, Latvia

Investigational Site Number 428003

🇱🇻

Riga, Latvia

Investigational Site Number 807501

🇲🇰

Skopje, Macedonia, The Former Yugoslav Republic of

Investigational Site Number 428004

🇱🇻

Daugavpils, Latvia

Investigational Site Number 410003

🇰🇷

Seoul, Korea, Republic of

Investigational Site Number 410015

🇰🇷

Wonju, Korea, Republic of

Investigational Site Number 410013

🇰🇷

Suwon, Korea, Republic of

Investigational Site Number 422502

🇱🇧

Beirut, Lebanon

Investigational Site Number 422505

🇱🇧

Beirut, Lebanon

Investigational Site Number 440001

🇱🇹

Siauliai, Lithuania

Investigational Site Number 484907

🇲🇽

Aguascalientes, Mexico

Investigational Site Number 484902

🇲🇽

Guadalajara, Mexico

Investigational Site Number 484004

🇲🇽

Monterrey, Mexico

Investigational Site Number 484015

🇲🇽

Guadalajara, Mexico

Investigational Site Number 484003

🇲🇽

Mexico City, Mexico

Investigational Site Number 484020

🇲🇽

Puebla, Mexico

Investigational Site Number 484009

🇲🇽

Aguascalientes, Mexico

Investigational Site Number 484901

🇲🇽

Guadalajara, Mexico

Investigational Site Number 484910

🇲🇽

Morelia, Michoacan, Mexico

Investigational Site Number 484012

🇲🇽

San Luis Potosi, Mexico

Investigational Site Number 484013

🇲🇽

Xalapa, Mexico

Investigational Site Number 484914

🇲🇽

México Df, Mexico

Investigational Site Number 484017

🇲🇽

Queretaro, Mexico

Investigational Site Number 499501

🇲🇪

Podgorica, Montenegro

Investigational Site Number 554002

🇳🇿

Nelson, New Zealand

Investigational Site Number 528005

🇳🇱

Arnhem, Netherlands

Investigational Site Number 528007

🇳🇱

Leeuwarden, Netherlands

Investigational Site Number 578901

🇳🇴

Bergen, Norway

Investigational Site Number 604012

🇵🇪

Lima, Peru

Investigational Site Number 528004

🇳🇱

Nieuwegein, Netherlands

Investigational Site Number 528002

🇳🇱

Rotterdam, Netherlands

Investigational Site Number 554001

🇳🇿

Hamilton, New Zealand

Investigational Site Number 578902

🇳🇴

Stavanger, Norway

Investigational Site Number 604006

🇵🇪

Lima, Peru

Investigational Site Number 616038

🇵🇱

Bialystok, Poland

Investigational Site Number 616009

🇵🇱

Bytom, Poland

Investigational Site Number 591504

🇵🇦

Panama, Panama

Investigational Site Number 604003

🇵🇪

Lima, Peru

Investigational Site Number 604008

🇵🇪

Lima, Peru

Investigational Site Number 616032

🇵🇱

Jelenia Gora, Poland

Investigational Site Number 616017

🇵🇱

Bydgoszcz, Poland

Investigational Site Number 616027

🇵🇱

Elk, Poland

Investigational Site Number 616022

🇵🇱

Torun, Poland

Investigational Site Number 616019

🇵🇱

Tarnów, Poland

Investigational Site Number 620015

🇵🇹

Ponta Delgada, Portugal

Investigational Site Number 620004

🇵🇹

Setúbal, Portugal

Investigational Site Number 620011

🇵🇹

Évora, Portugal

Investigational Site Number 642003

🇷🇴

Targu-Mures, Romania

Investigational Site Number 643004

🇷🇺

Moscow, Russian Federation

Investigational Site Number 643003

🇷🇺

Moscow, Russian Federation

Investigational Site Number 643016

🇷🇺

Nizniy Novgorod, Russian Federation

Investigational Site Number 643020

🇷🇺

Moscow, Russian Federation

Investigational Site Number 643001

🇷🇺

Moscow, Russian Federation

Investigational Site Number 643008

🇷🇺

Saint-Peterburg, Russian Federation

Investigational Site Number 710001

🇿🇦

Cape Town, South Africa

Investigational Site Number 643019

🇷🇺

Saint-Petersburg, Russian Federation

Investigational Site Number 643007

🇷🇺

St-Petersburg, Russian Federation

Investigational Site Number 703003

🇸🇰

Banska Bystrica, Slovakia

Investigational Site Number 643012

🇷🇺

Tomsk, Russian Federation

Investigational Site Number 643017

🇷🇺

Yaroslavl, Russian Federation

Investigational Site Number 702002

🇸🇬

Singapore, Singapore

Investigational Site Number 688501

🇷🇸

Kragujevac, Serbia

Investigational Site Number 688503

🇷🇸

Nis, Serbia

Investigational Site Number 688506

🇷🇸

Zemun, Serbia

Investigational Site Number 702001

🇸🇬

Singapore, Singapore

Investigational Site Number 724021

🇪🇸

Barcelona, Spain

Investigational Site Number 724002

🇪🇸

Barcelona, Spain

Investigational Site Number 724013

🇪🇸

Alcorcón, Spain

Investigational Site Number 724016

🇪🇸

Galdakao, Spain

Investigational Site Number 756002

🇨🇭

Zürich, Switzerland

Investigational Site Number 756001

🇨🇭

Lugano, Switzerland

Investigational Site Number 724027

🇪🇸

Madrid, Spain

Investigational Site Number 724003

🇪🇸

Madrid, Spain

Investigational Site Number 724023

🇪🇸

Girona, Spain

Investigational Site Number 724902

🇪🇸

Madrid, Spain

Investigational Site Number 724026

🇪🇸

Elche, Spain

Investigational Site Number 158003

🇨🇳

Linkou, Taiwan

Investigational Site Number 724006

🇪🇸

La Laguna, Spain

Investigational Site Number 724012

🇪🇸

Santiago De Compostela, Spain

Investigational Site Number 792010

🇹🇷

Adana, Turkey

Investigational Site Number 724010

🇪🇸

Torrevieja, Spain

Investigational Site Number 724024

🇪🇸

Valencia, Spain

Investigational Site Number 158007

🇨🇳

Kaohsiung, Taiwan

Investigational Site Number 158002

🇨🇳

Kaohsiung, Taiwan

Investigational Site Number 764002

🇹🇭

Bangkok, Thailand

Investigational Site Number 764004

🇹🇭

Khon Kaen, Thailand

Investigational Site Number 788002

🇹🇳

Ariana, Tunisia

Investigational Site Number 792023

🇹🇷

Ankara, Turkey

Investigational Site Number 792009

🇹🇷

Antalya, Turkey

Investigational Site Number 792006

🇹🇷

Erzurum, Turkey

Investigational Site Number 158001

🇨🇳

Taipei, Taiwan

Investigational Site Number 764901

🇹🇭

Bangkok, Thailand

Investigational Site Number 158009

🇨🇳

Taipei, Taiwan

Investigational Site Number 792022

🇹🇷

Bursa, Turkey

Investigational Site Number 792008

🇹🇷

Bursa, Turkey

Investigational Site Number 792020

🇹🇷

Eskisehir, Turkey

Investigational Site Number 792011

🇹🇷

Izmir, Turkey

Investigational Site Number 704003

🇻🇳

Ho Chi Minh City, Vietnam

Investigational Site Number 792001

🇹🇷

Izmir, Turkey

Investigational Site Number 792021

🇹🇷

Samsun, Turkey

Investigational Site Number 792019

🇹🇷

Mersin, Turkey

Investigational Site Number 792026

🇹🇷

Sivas, Turkey

Investigational Site Number 826008

🇬🇧

Bournemouth, United Kingdom

Investigational Site Number 792003

🇹🇷

Izmir, Turkey

Investigational Site Number 792014

🇹🇷

Kocaeli, Turkey

Investigational Site Number 792012

🇹🇷

Kayseri, Turkey

Investigational Site Number 804001

🇺🇦

Kharkiv, Ukraine

Investigational Site Number 792025

🇹🇷

Malatya, Turkey

Investigational Site Number 804005

🇺🇦

Lviv, Ukraine

Investigational Site Number 704001

🇻🇳

Ho Chi Minh City, Vietnam

Investigational Site Number 380904

🇮🇹

Brescia, Italy

Investigational Site Number 380928

🇮🇹

Brescia, Italy

Investigational Site Number 380930

🇮🇹

Catania, Italy

Investigational Site Number 380912

🇮🇹

Catania, Italy

Investigational Site Number 380932

🇮🇹

Cittadella, Italy

Investigational Site Number 380909

🇮🇹

Empoli, Italy

Investigational Site Number 380923

🇮🇹

Massa, Italy

Investigational Site Number 380935

🇮🇹

Massa, Italy

Investigational Site Number 380924

🇮🇹

Forlì, Italy

Investigational Site Number 380908

🇮🇹

Livorno, Italy

Investigational Site Number 380910

🇮🇹

Milano, Italy

Investigational Site Number 380905

🇮🇹

Modena, Italy

Investigational Site Number 380936

🇮🇹

Napoli, Italy

Investigational Site Number 380901

🇮🇹

Perugia, Italy

Investigational Site Number 380919

🇮🇹

Pordenone, Italy

Investigational Site Number 380921

🇮🇹

Rozzano, Italy

Investigational Site Number 380931

🇮🇹

Roma, Italy

Investigational Site Number 380916

🇮🇹

Reggio Emilia, Italy

Investigational Site Number 380925

🇮🇹

Treviso, Italy

Investigational Site Number 792030

🇹🇷

Edirne, Turkey

Investigational Site Number 792018

🇹🇷

Istanbul, Turkey

Investigational Site Number 792032

🇹🇷

Istanbul, Turkey

Investigational Site Number 792028

🇹🇷

Istanbul, Turkey

Investigational Site Number 792016

🇹🇷

Istanbul, Turkey

Investigational Site Number 792029

🇹🇷

Istanbul, Turkey

Investigational Site Number 792015

🇹🇷

Konya, Turkey

Investigational Site Number 826007

🇬🇧

Bradford, United Kingdom

Investigational Site Number 826001

🇬🇧

Craigavon, United Kingdom

Investigational Site Number 826005

🇬🇧

East Kilbride, United Kingdom

Investigational Site Number 826002

🇬🇧

Hull, United Kingdom

Investigational Site Number 826006

🇬🇧

Manchester, United Kingdom

Investigational Site Number 826003

🇬🇧

St Leonards, United Kingdom

Investigational Site Number 076007

🇧🇷

Sao Paulo, Brazil

Investigational Site Number 076022

🇧🇷

Porto Alegre, Brazil

Investigational Site Number 076015

🇧🇷

Marilia, Brazil

Investigational Site Number 076011

🇧🇷

Fortaleza, Brazil

Investigational Site Number 076009

🇧🇷

Porto Alegre, Brazil

Investigational Site Number 076001

🇧🇷

Porto Alegre, Brazil

Investigational Site Number 076014

🇧🇷

Sao Jose Do Rio Preto, Brazil

Investigational Site Number 076012

🇧🇷

Sao Paulo, Brazil

Investigational Site Number 076020

🇧🇷

Sao Paulo, Brazil

Investigational Site Number 076027

🇧🇷

Rio De Janeiro, Brazil

Investigational Site Number 076029

🇧🇷

Salvador, Brazil

Investigational Site Number 076008

🇧🇷

Uberlandia, Brazil

Investigational Site Number 076024

🇧🇷

Votuporanga, Brazil

Investigational Site Number 410017

🇰🇷

Daejeon, Korea, Republic of

Investigational Site Number 410011

🇰🇷

Seoul, Korea, Republic of

Investigational Site Number 410009

🇰🇷

Seoul, Korea, Republic of

Investigational Site Number 410010

🇰🇷

Seoul, Korea, Republic of

Investigational Site Number 276002

🇩🇪

Kassel, Germany

Investigational Site Number 840210

🇺🇸

St. Louis, Missouri, United States

Investigational Site Number 724007

🇪🇸

Cáceres, Spain

Investigational Site Number 724901

🇪🇸

Barcelona, Spain

Investigational Site Number 724904

🇪🇸

Murcia, Spain

Investigational Site Number 724017

🇪🇸

Málaga, Spain

Investigational Site Number 724005

🇪🇸

Santander, Spain

Investigational Site Number 724903

🇪🇸

Terrassa, Spain

Investigational Site Number 840193

🇺🇸

Oklahoma City, Oklahoma, United States

Investigational Site Number 840201

🇺🇸

Long Beach, California, United States

Investigational Site Number 840185

🇺🇸

Fort Lauderdale, Florida, United States

Investigational Site Number 840500

🇺🇸

Melbourne, Florida, United States

Investigational Site Number 840105

🇺🇸

Aurora, Illinois, United States

Investigational Site Number 380917

🇮🇹

Roma, Italy

Investigational Site Number 724018

🇪🇸

San Juan De Alicante, Spain

Investigational Site Number 840052

🇺🇸

St. Louis, Missouri, United States

Investigational Site Number 076023

🇧🇷

Recife, Brazil

Investigational Site Number 840205

🇺🇸

Chicago, Illinois, United States

Investigational Site Number 076030

🇧🇷

Recife, Brazil

Investigational Site Number 840532

🇺🇸

Boise, Idaho, United States

Investigational Site Number 840515

🇺🇸

Greenville, North Carolina, United States

Investigational Site Number 840903

🇺🇸

Northridge, California, United States

Investigational Site Number 840721

🇺🇸

Littleton, Colorado, United States

Investigational Site Number 840148

🇺🇸

Joliet, Illinois, United States

Investigational Site Number 840021

🇺🇸

Sarasota, Florida, United States

Investigational Site Number 840521

🇺🇸

Harvey, Illinois, United States

Investigational Site Number 840544

🇺🇸

Kalamazoo, Michigan, United States

Investigational Site Number 840564

🇺🇸

Lake Charles, Louisiana, United States

Investigational Site Number 840534

🇺🇸

Alexandria, Louisiana, United States

Investigational Site Number 840529

🇺🇸

Kalispell, Montana, United States

Investigational Site Number 840157

🇺🇸

Reno, Nevada, United States

Investigational Site Number 840566

🇺🇸

Raleigh, North Carolina, United States

Investigational Site Number 840539

🇺🇸

New York, New York, United States

Investigational Site Number 840908

🇺🇸

Winston Salem, North Carolina, United States

Investigational Site Number 840540

🇺🇸

Chambersburg, Pennsylvania, United States

Investigational Site Number 840519

🇺🇸

Doylestown, Pennsylvania, United States

Investigational Site Number 840075

🇺🇸

Pittsburgh, Pennsylvania, United States

Investigational Site Number 840072

🇺🇸

Oak Ridge, Tennessee, United States

Investigational Site Number 840211

🇺🇸

Washington, Pennsylvania, United States

Investigational Site Number 840715

🇺🇸

Fort Worth, Texas, United States

Investigational Site Number 840910

🇺🇸

Victoria, Texas, United States

Investigational Site Number 840513

🇺🇸

Manitowoc, Wisconsin, United States

Investigational Site Number 032046

🇦🇷

Buenos Aires, Argentina

Investigational Site Number 840121

🇺🇸

Tacoma, Washington, United States

Investigational Site Number 032013

🇦🇷

Avellaneda, Argentina

Investigational Site Number 032048

🇦🇷

Adrogue, Argentina

Investigational Site Number 032027

🇦🇷

La Plata, Argentina

Investigational Site Number 032033

🇦🇷

Olivos, Argentina

Investigational Site Number 032021

🇦🇷

Rosario, Argentina

Investigational Site Number 032005

🇦🇷

Rosario, Argentina

Investigational Site Number 032040

🇦🇷

Rosario, Argentina

Investigational Site Number 032024

🇦🇷

San Martin, Argentina

Investigational Site Number 056006

🇧🇪

Haine-Saint-Paul, Belgium

Investigational Site Number 076002

🇧🇷

Sao Jose Do Rio Preto, Brazil

Investigational Site Number 076004

🇧🇷

Porto Alegre, Brazil

Investigational Site Number 100503

🇧🇬

Sofia, Bulgaria

Investigational Site Number 100511

🇧🇬

Blagoevgrad, Bulgaria

Investigational Site Number 124006

🇨🇦

Hamilton, Canada

Investigational Site Number 124001

🇨🇦

Quebec, Canada

Investigational Site Number 124002

🇨🇦

Toronto, Canada

Investigational Site Number 152001

🇨🇱

Santiago, Chile

Investigational Site Number 152903

🇨🇱

Santiago, Chile

Investigational Site Number 152004

🇨🇱

Santiago, Chile

Investigational Site Number 152901

🇨🇱

Santiago, Chile

Investigational Site Number 152011

🇨🇱

Talcahuano, Chile

Investigational Site Number 170009

🇨🇴

Bogota, Colombia

Investigational Site Number 152908

🇨🇱

Temuco, Chile

Investigational Site Number 152913

🇨🇱

Temuco, Chile

Investigational Site Number 152907

🇨🇱

Vina Del Mar, Chile

Investigational Site Number 170011

🇨🇴

Bogotá, Colombia

Investigational Site Number 170012

🇨🇴

Cali, Colombia

Investigational Site Number 170003

🇨🇴

Medellin, Colombia

Investigational Site Number 170001

🇨🇴

Medellin, Colombia

Investigational Site Number 191502

🇭🇷

Slavonski Brod, Croatia

Investigational Site Number 170017

🇨🇴

Medellin, Colombia

Investigational Site Number 203005

🇨🇿

Brno, Czech Republic

Investigational Site Number 203903

🇨🇿

Hradec Kralove, Czech Republic

Investigational Site Number 203901

🇨🇿

Praha 2, Czech Republic

Investigational Site Number 250002

🇫🇷

Belfort Cedex, France

Investigational Site Number 250016

🇫🇷

Avignon Cedex 2, France

Investigational Site Number 250001

🇫🇷

Besancon, France

Investigational Site Number 250006

🇫🇷

Creteil, France

Investigational Site Number 250012

🇫🇷

Montfermeil, France

Investigational Site Number 250005

🇫🇷

Mulhouse, France

Investigational Site Number 250014

🇫🇷

Strasbourg, France

Investigational Site Number 250011

🇫🇷

Pau, France

Investigational Site Number 250008

🇫🇷

Toulouse Cedex 9, France

Investigational Site Number 276902

🇩🇪

Hamburg, Germany

Investigational Site Number 276006

🇩🇪

Frankfurt Am Main, Germany

Investigational Site Number 276018

🇩🇪

Rostock, Germany

Investigational Site Number 300011

🇬🇷

Athens, Greece

Investigational Site Number 276001

🇩🇪

Mainz, Germany

Investigational Site Number 276013

🇩🇪

Langen, Germany

Investigational Site Number 300001

🇬🇷

Athens, Greece

Investigational Site Number 300008

🇬🇷

Larissa, Greece

Investigational Site Number 300005

🇬🇷

N. Ionia, Greece

Investigational Site Number 300002

🇬🇷

Patras, Greece

Investigational Site Number 300010

🇬🇷

Thessaloniki, Greece

Investigational Site Number 348003

🇭🇺

Budapest, Hungary

Investigational Site Number 348004

🇭🇺

Budapest, Hungary

Investigational Site Number 348007

🇭🇺

Szekesfehervar, Hungary

Investigational Site Number 348002

🇭🇺

Budapest, Hungary

Investigational Site Number 348001

🇭🇺

Szolnok, Hungary

Investigational Site Number 356020

🇮🇳

Chandigarh, India

Investigational Site Number 348009

🇭🇺

Szeged, Hungary

Investigational Site Number 356008

🇮🇳

Bangalore, India

Investigational Site Number 348006

🇭🇺

Zalaegerszeg, Hungary

Investigational Site Number 356007

🇮🇳

Ahmedabad, India

Investigational Site Number 356012

🇮🇳

Allahabad, India

Investigational Site Number 356027

🇮🇳

Gurgaon, India

Investigational Site Number 356029

🇮🇳

Gurgaon, India

Investigational Site Number 356046

🇮🇳

Hyderabad, India

Investigational Site Number 356034

🇮🇳

Kolkata, India

Investigational Site Number 356037

🇮🇳

Kochi, India

Investigational Site Number 356018

🇮🇳

Mangalore, India

Investigational Site Number 356021

🇮🇳

Mumbai, India

Investigational Site Number 356022

🇮🇳

Nagpur, India

Investigational Site Number 356023

🇮🇳

Nagpur, India

Investigational Site Number 356001

🇮🇳

New Delhi, India

Investigational Site Number 356033

🇮🇳

Pune, India

Investigational Site Number 356024

🇮🇳

Secunderabad, India

Investigational Site Number 356044

🇮🇳

Vijaywada, India

Investigational Site Number 360501

🇮🇩

Depok, Indonesia

Investigational Site Number 356002

🇮🇳

Varanasi, India

Investigational Site Number 376005

🇮🇱

Afula, Israel

Investigational Site Number 376011

🇮🇱

Hadera, Israel

Investigational Site Number 376004

🇮🇱

Haifa, Israel

Investigational Site Number 360506

🇮🇩

Jakarta, Indonesia

Investigational Site Number 380907

🇮🇹

Pescara, Italy

Investigational Site Number 380914

🇮🇹

Seriate, Italy

Investigational Site Number 410002

🇰🇷

Daegu, Korea, Republic of

Investigational Site Number 440904

🇱🇹

Vilnius, Lithuania

Investigational Site Number 604002

🇵🇪

Lima, Peru

Investigational Site Number 604014

🇵🇪

Lima, Peru

Investigational Site Number 604011

🇵🇪

Lima, Peru

Investigational Site Number 616040

🇵🇱

Elblag, Poland

Investigational Site Number 616023

🇵🇱

Gdansk, Poland

Investigational Site Number 616037

🇵🇱

Katowice, Poland

Investigational Site Number 616016

🇵🇱

Ostroleka, Poland

Investigational Site Number 616033

🇵🇱

Rybnik, Poland

Investigational Site Number 620006

🇵🇹

Amadora, Portugal

Investigational Site Number 642002

🇷🇴

Brasov, Romania

Investigational Site Number 643025

🇷🇺

St-Petersburg, Russian Federation

Investigational Site Number 710005

🇿🇦

Cape Town, South Africa

Investigational Site Number 710004

🇿🇦

Alberton, South Africa

Investigational Site Number 710002

🇿🇦

Kuils River, South Africa

Investigational Site Number 710003

🇿🇦

Centurion, South Africa

Investigational Site Number 710007

🇿🇦

Pretoria, South Africa

Investigational Site Number 724014

🇪🇸

Badalona, Spain

Investigational Site Number 724001

🇪🇸

Alicante, Spain

Investigational Site Number 724025

🇪🇸

Barcelona, Spain

Investigational Site Number 788001

🇹🇳

Tunis, Tunisia

Investigational Site Number 792004

🇹🇷

Gaziantep, Turkey

Investigational Site Number 840520

🇺🇸

Washington, District of Columbia, United States

Investigational Site Number 840533

🇺🇸

New Orleans, Louisiana, United States

Investigational Site Number 032032

🇦🇷

Buenos Aires, Argentina

Investigational Site Number 100512

🇧🇬

Pazardjik, Bulgaria

Investigational Site Number 100501

🇧🇬

Sofia, Bulgaria

Investigational Site Number 203902

🇨🇿

Liberec, Czech Republic

Investigational Site Number 203009

🇨🇿

Olomouc, Czech Republic

Investigational Site Number 203010

🇨🇿

Ostrava - Poruba, Czech Republic

Investigational Site Number 203001

🇨🇿

Praha 10, Czech Republic

Investigational Site Number 203003

🇨🇿

Praha 5, Czech Republic

Investigational Site Number 203002

🇨🇿

Usti Nad Labem, Czech Republic

Investigational Site Number 203007

🇨🇿

Praha 5, Czech Republic

Investigational Site Number 356016

🇮🇳

Mumbai, India

Investigational Site Number 356011

🇮🇳

Mysore, India

Investigational Site Number 356025

🇮🇳

New Delhi, India

Investigational Site Number 376013

🇮🇱

Jerusalem, Israel

Investigational Site Number 616005

🇵🇱

Bialystok, Poland

Investigational Site Number 616047

🇵🇱

Radom, Poland

Investigational Site Number 616031

🇵🇱

Wloclawek, Poland

Investigational Site Number 616015

🇵🇱

Wroclaw, Poland

Investigational Site Number 643011

🇷🇺

Kemerovo, Russian Federation

Investigational Site Number 643014

🇷🇺

Krasnodar, Russian Federation

Investigational Site Number 643021

🇷🇺

Krasnoyarsk, Russian Federation

Investigational Site Number 643024

🇷🇺

Novosibirsk, Russian Federation

Investigational Site Number 643013

🇷🇺

Samara, Russian Federation

Investigational Site Number 643006

🇷🇺

St-Petersburg, Russian Federation

Investigational Site Number 643023

🇷🇺

Volgograd, Russian Federation

Investigational Site Number 688505

🇷🇸

Belgrade, Serbia

Investigational Site Number 643005

🇷🇺

Moscow, Russian Federation

Investigational Site Number 704004

🇻🇳

Ho Chi Minh City, Vietnam

Investigational Site Number 704005

🇻🇳

Ho Chi Minh City, Vietnam

Investigational Site Number 840166

🇺🇸

New Haven, Connecticut, United States

Investigational Site Number 840553

🇺🇸

Richmond, Virginia, United States

Investigational Site Number 840188

🇺🇸

Richmond, Virginia, United States

Investigational Site Number 840577

🇺🇸

Orlando, Florida, United States

Investigational Site Number 840568

🇺🇸

Louisville, Kentucky, United States

Investigational Site Number 840194

🇺🇸

Kansas City, Missouri, United States

Investigational Site Number 840138

🇺🇸

Kansas City, Missouri, United States

Investigational Site Number 840056

🇺🇸

Kansas City, Missouri, United States

Investigational Site Number 840059

🇺🇸

Omaha, Nebraska, United States

Investigational Site Number 840727

🇺🇸

Omaha, Nebraska, United States

Investigational Site Number 840508

🇺🇸

Tampa, Florida, United States

Investigational Site Number 840079

🇺🇸

Omaha, Nebraska, United States

Investigational Site Number 840203

🇺🇸

Austin, Texas, United States

Investigational Site Number 840574

🇺🇸

Austin, Texas, United States

Investigational Site Number 344001

🇭🇰

Chai Wan, Hong Kong

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