Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

NCT ID: NCT06307652

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

4800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-12

Study Completion Date

2027-06-11

Brief Summary

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This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

Detailed Description

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The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event.

Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments:

1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule

The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin.

The study will be conducted at approximately 700 sites in approximately 40 countries globally.

Conditions

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Heart Failure and Impaired Kidney Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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balcinrenone/dapagliflozin 15 mg/10 mg

Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

Group Type EXPERIMENTAL

balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg

Intervention Type DRUG

1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use

balcinrenone/dapagliflozin 40 mg/10 mg

Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

Group Type EXPERIMENTAL

balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg

Intervention Type DRUG

1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use

dapagliflozin 10 mg

Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

Group Type ACTIVE_COMPARATOR

dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

Intervention Type DRUG

1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use

Interventions

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balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg

1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use

Intervention Type DRUG

balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg

1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use

Intervention Type DRUG

dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
* Having had a recent HF event within 6 months (hospitalization or urgent visit)
* Have a LVEF value from an assessment within the last 12 months
* Managed with SoC therapy for HF and renal impairment according to local guidelines
* NT-proBNP must be \>300 pg/mL (\>600 pg/mL if concomitant atrial fibrillation or atrial flutter)
* Not taking an MRA
* An eGFR ≥ 20 to \< 60 mL/min/1.73 m2
* Serum/plasma potassium ≤ 5.0 mmol/L

Exclusion Criteria

* Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period
* Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations
* History of hypertrophic obstructive cardiomyopathy
* Complex congenital heart disease or severe uncorrected primary valvular disease
* Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
* Systolic BP \< 90 mmHg, or symptomatic hypotension within the past 24 hours
* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment
* Type 1 diabetes mellitus
* Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy
* Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy
* Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks
* Treatment with strong or moderate CYP3A4 inhibitor or inducer
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Alexander City, Alabama, United States

Site Status RECRUITING

Research Site

Birmingham, Alabama, United States

Site Status WITHDRAWN

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Fairhope, Alabama, United States

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Huntsville, Alabama, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Covina, California, United States

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Encinitas, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Orange, California, United States

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Redding, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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Santa Ana, California, United States

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Thousand Oaks, California, United States

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Vista, California, United States

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West Hills, California, United States

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Aurora, Colorado, United States

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Wheat Ridge, Colorado, United States

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Altamonte Springs, Florida, United States

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Boca Raton, Florida, United States

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Bradenton, Florida, United States

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Clearwater, Florida, United States

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Delray Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Palm Beach Gardens, Florida, United States

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Pensacola, Florida, United States

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Port Charlotte, Florida, United States

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Safety Harbor, Florida, United States

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Saint Augustine, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Peachtree City, Georgia, United States

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Thomasville, Georgia, United States

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Tucker, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Glenview, Illinois, United States

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Hazel Crest, Illinois, United States

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North Chicago, Illinois, United States

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Peoria, Illinois, United States

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Winfield, Illinois, United States

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Elkhart, Indiana, United States

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Evansville, Indiana, United States

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Hammond, Indiana, United States

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Indianapolis, Indiana, United States

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Muncie, Indiana, United States

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Munster, Indiana, United States

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Richmond, Indiana, United States

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Waterloo, Iowa, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Alexandria, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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West Monroe, Louisiana, United States

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Augusta, Maine, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Fall River, Massachusetts, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Bloomfield Hills, Michigan, United States

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Dearborn, Michigan, United States

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Farmington Hills, Michigan, United States

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Flint, Michigan, United States

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Troy, Michigan, United States

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Ypsilanti, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Paul, Minnesota, United States

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Jackson, Mississippi, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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North Las Vegas, Nevada, United States

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Bridgewater, New Jersey, United States

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Somerset, New Jersey, United States

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Brooklyn, New York, United States

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Manhasset, New York, United States

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New Windsor, New York, United States

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New York, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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Stony Brook, New York, United States

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The Bronx, New York, United States

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The Bronx, New York, United States

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Asheville, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Pinehurst, North Carolina, United States

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Statesville, North Carolina, United States

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Wilmington, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Maumee, Ohio, United States

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Springfield, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Abington, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Horsham, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Providence, Rhode Island, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Ladson, South Carolina, United States

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Lancaster, South Carolina, United States

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Rapid City, South Dakota, United States

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Jackson, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Tullahoma, Tennessee, United States

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Allen, Texas, United States

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Amarillo, Texas, United States

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Amarillo, Texas, United States

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Cypress, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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Mansfield, Texas, United States

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McKinney, Texas, United States

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McKinney, Texas, United States

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Odessa, Texas, United States

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Pearland, Texas, United States

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San Antonio, Texas, United States

Site Status NOT_YET_RECRUITING

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Sherman, Texas, United States

Site Status TERMINATED

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Temple, Texas, United States

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Tyler, Texas, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Falls Church, Virginia, United States

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Newport News, Virginia, United States

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Puyallup, Washington, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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CABA, , Argentina

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Ciudad de Buenos Aires, , Argentina

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Ciudad de Buenos Aires, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Esperanza, , Argentina

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Ganadero Baigorria, , Argentina

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Mar del Plata, , Argentina

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Rosario, , Argentina

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San Juan Bautista, , Argentina

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San Miguel de Tucumán, , Argentina

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San Miguel de Tucumán, , Argentina

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San Miguel de Tucumán, , Argentina

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Santa Fe, , Argentina

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Blacktown, , Australia

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Cairns, , Australia

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Canberra, , Australia

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Chermside, , Australia

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Clayton, , Australia

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Concord, , Australia

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Frankston, , Australia

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Geelong, , Australia

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Murdoch, , Australia

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North Tamworth, , Australia

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Braunau am Inn, , Austria

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Graz, , Austria

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Linz, , Austria

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Saint Stefan/Stainz, , Austria

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Salzburg, , Austria

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Sankt Pölten, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Aracaju, , Brazil

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Blumenau, , Brazil

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Brasília, , Brazil

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Campina Grande do Sul, , Brazil

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Campinas, , Brazil

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Curitiba, , Brazil

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Goiânia, , Brazil

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Porto Alegre, , Brazil

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Rio de Janeiro, , Brazil

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Rio de Janeiro, , Brazil

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Rio de Janeiro, , Brazil

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São José dos Campos, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Teresina, , Brazil

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Uberlândia, , Brazil

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Botevgrad, , Bulgaria

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Dupnitsa, , Bulgaria

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Haskovo, , Bulgaria

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Kozloduy, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Plovdiv, , Bulgaria

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Sliven, , Bulgaria

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Sliven, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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New Westminster, British Columbia, Canada

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North Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Sydney, Nova Scotia, Canada

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Cambridge, Ontario, Canada

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Cambridge, Ontario, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Newmarket, Ontario, Canada

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North York, Ontario, Canada

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Oakville, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Peterborough, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Saint-Jean-sur-Richelieu, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Antofagasta, , Chile

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Punta Arenas, , Chile

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Region Metropolitana, , Chile

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San Bernardo, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Talcahuano, , Chile

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Temuco, , Chile

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Temuco, , Chile

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Valdivia, , Chile

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Victoria, , Chile

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Baotou, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Changchun, , China

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Changsha, , China

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Changsha, , China

Site Status RECRUITING

Research Site

Chengdu, , China

Site Status RECRUITING

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Chengdu, , China

Site Status RECRUITING

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Chifeng, , China

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Chongqing, , China

Site Status RECRUITING

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Guangzhou, , China

Site Status RECRUITING

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Guangzhou, , China

Site Status RECRUITING

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Guangzhou, , China

Site Status RECRUITING

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Hangzhou, , China

Site Status RECRUITING

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Harbin, , China

Site Status RECRUITING

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Hengyang, , China

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Heze, , China

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Hohhot, , China

Site Status WITHDRAWN

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Jinan, , China

Site Status RECRUITING

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Jining, , China

Site Status RECRUITING

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Lanzhou, , China

Site Status RECRUITING

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Liaocheng, , China

Site Status RECRUITING

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Linhai, , China

Site Status RECRUITING

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Nanchang, , China

Site Status RECRUITING

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Nanchong, , China

Site Status COMPLETED

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Nanjing, , China

Site Status RECRUITING

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Nanjing, , China

Site Status RECRUITING

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Nanjing, , China

Site Status RECRUITING

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Nanjing, , China

Site Status RECRUITING

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Ningbo, , China

Site Status RECRUITING

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Pingxiang, , China

Site Status RECRUITING

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Quzhou, , China

Site Status RECRUITING

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Sanya, , China

Site Status RECRUITING

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Shanghai, , China

Site Status RECRUITING

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Shanghai, , China

Site Status RECRUITING

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Shenyang, , China

Site Status RECRUITING

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Shenzhen, , China

Site Status RECRUITING

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Ürümqi, , China

Site Status RECRUITING

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Wuhan, , China

Site Status WITHDRAWN

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Wuhan, , China

Site Status WITHDRAWN

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Xi'an, , China

Site Status RECRUITING

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Xi'an, , China

Site Status RECRUITING

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Xianyang, , China

Site Status WITHDRAWN

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Xuzhou, , China

Site Status RECRUITING

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Xuzhou, , China

Site Status RECRUITING

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Yangzhou, , China

Site Status RECRUITING

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Zhangjiakou, , China

Site Status RECRUITING

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Zunyi, , China

Site Status RECRUITING

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Armenia, , Colombia

Site Status RECRUITING

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Barranquilla, , Colombia

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Barranquilla, , Colombia

Site Status RECRUITING

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Bogotá, , Colombia

Site Status SUSPENDED

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Bogotá, , Colombia

Site Status RECRUITING

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Cali, , Colombia

Site Status RECRUITING

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Cali, , Colombia

Site Status RECRUITING

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Manizales, , Colombia

Site Status NOT_YET_RECRUITING

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Medellín, , Colombia

Site Status RECRUITING

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Medellín, , Colombia

Site Status RECRUITING

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Piedecuesta, , Colombia

Site Status RECRUITING

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Rionegro, , Colombia

Site Status RECRUITING

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Brno, , Czechia

Site Status RECRUITING

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Brno, , Czechia

Site Status SUSPENDED

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Broumov, , Czechia

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Česká Lípa, , Czechia

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Jaroměř, , Czechia

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Louny, , Czechia

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Ostrava, , Czechia

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Pilsen, , Czechia

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Plzen - Bory, , Czechia

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Prague, , Czechia

Site Status SUSPENDED

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Přerov, , Czechia

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Slaný, , Czechia

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Svitavy, , Czechia

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Ustí Nad Labem, , Czechia

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Ústí nad Labem, , Czechia

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Zlín, , Czechia

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Helsinki, , Finland

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Tampere, , Finland

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Turku, , Finland

Site Status RECRUITING

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Béziers, , France

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Bron, , France

Site Status WITHDRAWN

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Caen, , France

Site Status WITHDRAWN

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Cholet, , France

Site Status RECRUITING

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Créteil, , France

Site Status RECRUITING

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Dijon, , France

Site Status RECRUITING

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La Roche-sur-Yon, , France

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La Tronche, , France

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Le Coudray, , France

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Limoges, , France

Site Status RECRUITING

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Meaux, , France

Site Status RECRUITING

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Montauban, , France

Site Status WITHDRAWN

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Montpellier, , France

Site Status RECRUITING

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Montpellier, , France

Site Status RECRUITING

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Nantes, , France

Site Status RECRUITING

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Orléans, , France

Site Status WITHDRAWN

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Paris, , France

Site Status RECRUITING

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Paris, , France

Site Status RECRUITING

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Poitiers, , France

Site Status RECRUITING

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Reims, , France

Site Status RECRUITING

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Rennes, , France

Site Status RECRUITING

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Rouen, , France

Site Status RECRUITING

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Saint-Quentin, , France

Site Status RECRUITING

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Strasbourg, , France

Site Status WITHDRAWN

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Toulon, , France

Site Status RECRUITING

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Toulouse, , France

Site Status RECRUITING

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Tours, , France

Site Status WITHDRAWN

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Valenciennes, , France

Site Status RECRUITING

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Bad Nauheim, , Germany

Site Status SUSPENDED

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Bechhofen, , Germany

Site Status WITHDRAWN

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Berlin, , Germany

Site Status RECRUITING

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Bernau bei Berlin, , Germany

Site Status RECRUITING

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Chemnitz, , Germany

Site Status WITHDRAWN

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Coburg, , Germany

Site Status RECRUITING

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Dresden, , Germany

Site Status WITHDRAWN

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Dresden, , Germany

Site Status RECRUITING

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Elsterwerda, , Germany

Site Status SUSPENDED

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Frankfurt, , Germany

Site Status SUSPENDED

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Freiburg im Breisgau, , Germany

Site Status RECRUITING

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Hagen, , Germany

Site Status RECRUITING

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Hamburg, , Germany

Site Status RECRUITING

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Hamburg, , Germany

Site Status WITHDRAWN

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Hamburg, , Germany

Site Status WITHDRAWN

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Heidelberg, , Germany

Site Status RECRUITING

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Kaiserslautern, , Germany

Site Status WITHDRAWN

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Langen, , Germany

Site Status WITHDRAWN

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Leipzig, , Germany

Site Status SUSPENDED

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Leverkusen, , Germany

Site Status SUSPENDED

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Mainz, , Germany

Site Status WITHDRAWN

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Mönchengladbach, , Germany

Site Status RECRUITING

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Münster, , Germany

Site Status SUSPENDED

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Papenburg, , Germany

Site Status RECRUITING

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Regensburg, , Germany

Site Status RECRUITING

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Rostock, , Germany

Site Status WITHDRAWN

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Völklingen, , Germany

Site Status WITHDRAWN

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Wermsdorf, , Germany

Site Status SUSPENDED

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Witten, , Germany

Site Status WITHDRAWN

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Athens, , Greece

Site Status RECRUITING

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Athens, , Greece

Site Status RECRUITING

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Athens, , Greece

Site Status RECRUITING

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

Site Status RECRUITING

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Athens, , Greece

Site Status RECRUITING

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Dragana, , Greece

Site Status RECRUITING

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Heraklio, , Greece

Site Status COMPLETED

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Thessaloniki, , Greece

Site Status RECRUITING

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Thessaloniki, , Greece

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Balatonfüred, , Hungary

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Békéscsaba, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

Site Status RECRUITING

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Budapest, , Hungary

Site Status WITHDRAWN

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Gyula, , Hungary

Site Status WITHDRAWN

Research Site

Hódmezővásárhely, , Hungary

Site Status WITHDRAWN

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Kecskemét, , Hungary

Site Status RECRUITING

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Orosháza, , Hungary

Site Status WITHDRAWN

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Pécs, , Hungary

Site Status RECRUITING

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Pécs, , Hungary

Site Status RECRUITING

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Székesfehérvár, , Hungary

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Ahmedabad, , India

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Ajmer, , India

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Bangalore, , India

Site Status RECRUITING

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Belagavi, , India

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Coimbatore, , India

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Dehradun, , India

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Delhi, , India

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Hyderabad, , India

Site Status WITHDRAWN

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Hyderabad, , India

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Hyderabad, , India

Site Status RECRUITING

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Kanpur, , India

Site Status RECRUITING

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Karamsad, , India

Site Status WITHDRAWN

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Kolkata, , India

Site Status RECRUITING

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Kolkata, , India

Site Status RECRUITING

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Manipal, , India

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Meerut, , India

Site Status RECRUITING

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Mysuru, , India

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Nagpur, , India

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New Delhi, , India

Site Status RECRUITING

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New Delhi, , India

Site Status RECRUITING

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New Delhi, , India

Site Status NOT_YET_RECRUITING

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Pune, , India

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Rudrapur, , India

Site Status NOT_YET_RECRUITING

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Vijayawada, , India

Site Status SUSPENDED

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Afula, , Israel

Site Status RECRUITING

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Ashkelon, , Israel

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Beersheba, , Israel

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Be’er Ya‘aqov, , Israel

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Haifa, , Israel

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Holon, , Israel

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Jerusalem, , Israel

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Kfar Saba, , Israel

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Nahariya, , Israel

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Tiberias, , Israel

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Acquaviva delle Fonti, , Italy

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Bari, , Italy

Site Status RECRUITING

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Bergamo, , Italy

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Brescia, , Italy

Site Status RECRUITING

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Catania, , Italy

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Catanzaro, , Italy

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Cona, , Italy

Site Status RECRUITING

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Cortona, , Italy

Site Status RECRUITING

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Florence, , Italy

Site Status WITHDRAWN

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Milan, , Italy

Site Status RECRUITING

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Novara, , Italy

Site Status WITHDRAWN

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Pavia, , Italy

Site Status RECRUITING

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San Giovanni Rotondo, , Italy

Site Status WITHDRAWN

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Beppu-shi, , Japan

Site Status RECRUITING

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Bunkyō City, , Japan

Site Status RECRUITING

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Fujisawa-shi, , Japan

Site Status RECRUITING

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Fukui-shi, , Japan

Site Status RECRUITING

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

Site Status RECRUITING

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Fukutsu-shi, , Japan

Site Status RECRUITING

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Hakusan-shi, , Japan

Site Status RECRUITING

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Higashiibaraki-gun, , Japan

Site Status RECRUITING

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Himeji, , Japan

Site Status RECRUITING

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Iwakuni-shi, , Japan

Site Status RECRUITING

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Kanazawa, , Japan

Site Status RECRUITING

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Kanazawa, , Japan

Site Status WITHDRAWN

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Kanonji-shi, , Japan

Site Status RECRUITING

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Kasuga-shi, , Japan

Site Status SUSPENDED

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Kasugai-shi, , Japan

Site Status RECRUITING

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Kawaguchi, , Japan

Site Status RECRUITING

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Kawanishi-shi, , Japan

Site Status RECRUITING

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Kishiwada-shi, , Japan

Site Status RECRUITING

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Kitakyusyu-shi, , Japan

Site Status SUSPENDED

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Kobe, , Japan

Site Status RECRUITING

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Kochi, , Japan

Site Status RECRUITING

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Kure-shi, , Japan

Site Status RECRUITING

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Maebashi, , Japan

Site Status RECRUITING

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Matsumoto-shi, , Japan

Site Status RECRUITING

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Meguro-ku, , Japan

Site Status RECRUITING

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Mito, , Japan

Site Status RECRUITING

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Moriyama-shi, , Japan

Site Status RECRUITING

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Nagoya, , Japan

Site Status SUSPENDED

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Osaka, , Japan

Site Status RECRUITING

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Osaka, , Japan

Site Status RECRUITING

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Ōita, , Japan

Site Status RECRUITING

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Sagamihara-shi, , Japan

Site Status RECRUITING

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Saitama Shi, , Japan

Site Status RECRUITING

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Saitama-shi, , Japan

Site Status WITHDRAWN

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Sakaishi, , Japan

Site Status RECRUITING

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Sakata, , Japan

Site Status SUSPENDED

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Sanyoonoda-shi, , Japan

Site Status RECRUITING

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Toshima-ku, , Japan

Site Status RECRUITING

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Toyota, , Japan

Site Status RECRUITING

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Tsuchiura-shi, , Japan

Site Status TERMINATED

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Ueda-shi, , Japan

Site Status RECRUITING

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Uji-shi, , Japan

Site Status RECRUITING

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Uwajima-shi, , Japan

Site Status RECRUITING

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Yanagawa-shi, , Japan

Site Status RECRUITING

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Yokohama, , Japan

Site Status RECRUITING

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Yokohama, , Japan

Site Status WITHDRAWN

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Kajang, , Malaysia

Site Status RECRUITING

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Kota Kinabalu, , Malaysia

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Kota Samarahan, , Malaysia

Site Status RECRUITING

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Kuala Lumpur, , Malaysia

Site Status RECRUITING

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Kuala Terengganu, , Malaysia

Site Status RECRUITING

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Kuantan, , Malaysia

Site Status RECRUITING

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Sungai Buloh, , Malaysia

Site Status RECRUITING

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Aguascalientes, , Mexico

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Aguascalientes, , Mexico

Site Status NOT_YET_RECRUITING

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Chihuahua City, , Mexico

Site Status RECRUITING

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Cuauhtémoc, , Mexico

Site Status RECRUITING

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Cuauhtémoc, , Mexico

Site Status NOT_YET_RECRUITING

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Culiacán, , Mexico

Site Status RECRUITING

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Culiacán, , Mexico

Site Status RECRUITING

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Guadalajara, , Mexico

Site Status NOT_YET_RECRUITING

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Mazatlán, , Mexico

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Metepec, , Mexico

Site Status RECRUITING

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Mexico City, , Mexico

Site Status WITHDRAWN

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Mexico City, , Mexico

Site Status NOT_YET_RECRUITING

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México, , Mexico

Site Status RECRUITING

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México, , Mexico

Site Status WITHDRAWN

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México, , Mexico

Site Status NOT_YET_RECRUITING

Research Site

Monterrey, , Mexico

Site Status NOT_YET_RECRUITING

Research Site

Monterrey, , Mexico

Site Status NOT_YET_RECRUITING

Research Site

Morelia, , Mexico

Site Status NOT_YET_RECRUITING

Research Site

Querétaro, , Mexico

Site Status RECRUITING

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San Luis Potosí City, , Mexico

Site Status WITHDRAWN

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Tijuana, , Mexico

Site Status RECRUITING

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Torreón, , Mexico

Site Status RECRUITING

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Veracruz, , Mexico

Site Status NOT_YET_RECRUITING

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Xalapa, , Mexico

Site Status NOT_YET_RECRUITING

Research Site

Amsterdam, , Netherlands

Site Status RECRUITING

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Arnhem, , Netherlands

Site Status RECRUITING

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Emmen, , Netherlands

Site Status RECRUITING

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Goes, , Netherlands

Site Status RECRUITING

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Hardenberg, , Netherlands

Site Status RECRUITING

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Leeuwarden, , Netherlands

Site Status RECRUITING

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Bellavista, , Peru

Site Status RECRUITING

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Lima, , Peru

Site Status RECRUITING

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Lima, , Peru

Site Status WITHDRAWN

Research Site

Lima, , Peru

Site Status RECRUITING

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Lima, , Peru

Site Status NOT_YET_RECRUITING

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Lima, , Peru

Site Status RECRUITING

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Lima, , Peru

Site Status NOT_YET_RECRUITING

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Lima, , Peru

Site Status WITHDRAWN

Research Site

Lima, , Peru

Site Status RECRUITING

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Lima, , Peru

Site Status RECRUITING

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Lima, , Peru

Site Status RECRUITING

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Lima, , Peru

Site Status RECRUITING

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Piura, , Peru

Site Status RECRUITING

Research Site

Angeles City, , Philippines

Site Status RECRUITING

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Cebu City, , Philippines

Site Status WITHDRAWN

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Cebu City, , Philippines

Site Status RECRUITING

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City of Taguig, , Philippines

Site Status RECRUITING

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Davao City, , Philippines

Site Status RECRUITING

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Davao City, , Philippines

Site Status NOT_YET_RECRUITING

Research Site

Davao City, , Philippines

Site Status RECRUITING

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Iloilo City, , Philippines

Site Status RECRUITING

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Las Piñas, , Philippines

Site Status RECRUITING

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Mabalacat, , Philippines

Site Status RECRUITING

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Makati, , Philippines

Site Status RECRUITING

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Manadaluyong City, , Philippines

Site Status RECRUITING

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Manila, , Philippines

Site Status WITHDRAWN

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Marikina City, , Philippines

Site Status RECRUITING

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Pasig, , Philippines

Site Status RECRUITING

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Quezon City, , Philippines

Site Status RECRUITING

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Quezon City, , Philippines

Site Status RECRUITING

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Quezon City, , Philippines

Site Status RECRUITING

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Roxas City, , Philippines

Site Status RECRUITING

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West San Juan City, , Philippines

Site Status RECRUITING

Research Site

Biała Podlaska, , Poland

Site Status RECRUITING

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Bielsko-Biala, , Poland

Site Status WITHDRAWN

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Bydgoszcz, , Poland

Site Status WITHDRAWN

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Bydgoszcz, , Poland

Site Status TERMINATED

Research Site

Chrzanów, , Poland

Site Status RECRUITING

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Gdansk, , Poland

Site Status RECRUITING

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Gdansk, , Poland

Site Status RECRUITING

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Gdynia, , Poland

Site Status WITHDRAWN

Research Site

Katowice, , Poland

Site Status RECRUITING

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Kazimierza Wielka, , Poland

Site Status RECRUITING

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Kędzierzyn-Koźle, , Poland

Site Status RECRUITING

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Krakow, , Poland

Site Status RECRUITING

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Krakow, , Poland

Site Status RECRUITING

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Krakow, , Poland

Site Status NOT_YET_RECRUITING

Research Site

Krakow, , Poland

Site Status RECRUITING

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Krakow, , Poland

Site Status WITHDRAWN

Research Site

Lodz, , Poland

Site Status RECRUITING

Research Site

Lodz, , Poland

Site Status WITHDRAWN

Research Site

Lodz, , Poland

Site Status RECRUITING

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Lodz, , Poland

Site Status RECRUITING

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Lublin, , Poland

Site Status COMPLETED

Research Site

Lublin, , Poland

Site Status RECRUITING

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Lublin, , Poland

Site Status RECRUITING

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Olsztyn, , Poland

Site Status RECRUITING

Research Site

Ostrów Mazowiecka, , Poland

Site Status RECRUITING

Research Site

Piekary Śląskie, , Poland

Site Status RECRUITING

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Poznan, , Poland

Site Status RECRUITING

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Poznan, , Poland

Site Status RECRUITING

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Rzeszów, , Poland

Site Status WITHDRAWN

Research Site

Rzeszów, , Poland

Site Status RECRUITING

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Szczecin, , Poland

Site Status RECRUITING

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Tarnów, , Poland

Site Status RECRUITING

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Torun, , Poland

Site Status RECRUITING

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Tychy, , Poland

Site Status RECRUITING

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Warsaw, , Poland

Site Status RECRUITING

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Warsaw, , Poland

Site Status WITHDRAWN

Research Site

Warsaw, , Poland

Site Status WITHDRAWN

Research Site

Wroclaw, , Poland

Site Status WITHDRAWN

Research Site

Wroclaw, , Poland

Site Status RECRUITING

Research Site

Zabrze, , Poland

Site Status RECRUITING

Research Site

Afumaţi, , Romania

Site Status NOT_YET_RECRUITING

Research Site

Arad, , Romania

Site Status NOT_YET_RECRUITING

Research Site

Baia Mare, , Romania

Site Status NOT_YET_RECRUITING

Research Site

Brasov, , Romania

Site Status RECRUITING

Research Site

Brasov, , Romania

Site Status NOT_YET_RECRUITING

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Bucharest, , Romania

Site Status WITHDRAWN

Research Site

Bucharest, , Romania

Site Status TERMINATED

Research Site

Bucharest, , Romania

Site Status RECRUITING

Research Site

Bucharest, , Romania

Site Status RECRUITING

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Bucharest, , Romania

Site Status WITHDRAWN

Research Site

Cluj-Napoca, , Romania

Site Status TERMINATED

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Iași, , Romania

Site Status SUSPENDED

Research Site

Iași, , Romania

Site Status RECRUITING

Research Site

Satu Mare, , Romania

Site Status RECRUITING

Research Site

Târgu Mureş, , Romania

Site Status RECRUITING

Research Site

Târgu Mureş, , Romania

Site Status RECRUITING

Research Site

Timișoara, , Romania

Site Status RECRUITING

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Timișoara, , Romania

Site Status TERMINATED

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Dammam, , Saudi Arabia

Site Status NOT_YET_RECRUITING

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Jeddah, , Saudi Arabia

Site Status RECRUITING

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Riyadh, , Saudi Arabia

Site Status RECRUITING

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Riyadh, , Saudi Arabia

Site Status RECRUITING

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Riyadh, , Saudi Arabia

Site Status NOT_YET_RECRUITING

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Riyadh, , Saudi Arabia

Site Status RECRUITING

Research Site

Riyadh, , Saudi Arabia

Site Status RECRUITING

Research Site

Banská Bystrica, , Slovakia

Site Status RECRUITING

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Bratislava, , Slovakia

Site Status RECRUITING

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Bratislava, , Slovakia

Site Status RECRUITING

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Brezno, , Slovakia

Site Status RECRUITING

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Košice, , Slovakia

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Research Site

Košice, , Slovakia

Site Status RECRUITING

Research Site

Martin, , Slovakia

Site Status RECRUITING

Research Site

Myjava, , Slovakia

Site Status RECRUITING

Research Site

Nitra, , Slovakia

Site Status RECRUITING

Research Site

Nové Zámky, , Slovakia

Site Status WITHDRAWN

Research Site

Považská Bystrica, , Slovakia

Site Status RECRUITING

Research Site

Prešov, , Slovakia

Site Status WITHDRAWN

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Rimavská Sobota, , Slovakia

Site Status RECRUITING

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Svidník, , Slovakia

Site Status RECRUITING

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Bloemfontein, , South Africa

Site Status RECRUITING

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Centurion, , South Africa

Site Status RECRUITING

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Durban, , South Africa

Site Status RECRUITING

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Johannesburg, , South Africa

Site Status RECRUITING

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KwaDukuza, , South Africa

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Panorama, , South Africa

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Parow, , South Africa

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Pietermaritzburg, , South Africa

Site Status RECRUITING

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Somerset West, , South Africa

Site Status RECRUITING

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Soweto, , South Africa

Site Status RECRUITING

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Worcester, , South Africa

Site Status WITHDRAWN

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Anyang-si, , South Korea

Site Status RECRUITING

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Bucheon-si, , South Korea

Site Status RECRUITING

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Busan, , South Korea

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Busan, , South Korea

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Busan, , South Korea

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Busan, , South Korea

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Cheongju-si, , South Korea

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Daegu, , South Korea

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Daejeon, , South Korea

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Gwangju, , South Korea

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Gwangmyeong, , South Korea

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Incheon, , South Korea

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Junggu, , South Korea

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Seongnam-si, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

Site Status RECRUITING

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Seoul, , South Korea

Site Status RECRUITING

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Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status WITHDRAWN

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Seoul, , South Korea

Site Status RECRUITING

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Seoul, , South Korea

Site Status RECRUITING

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Uijeongbu-si, , South Korea

Site Status RECRUITING

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Wŏnju, , South Korea

Site Status SUSPENDED

Research Site

Yangsan, , South Korea

Site Status RECRUITING

Research Site

A Coruña, , Spain

Site Status RECRUITING

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Barcelona, , Spain

Site Status RECRUITING

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Barcelona, , Spain

Site Status RECRUITING

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Barcelona, , Spain

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Lugo, , Spain

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Madrid, , Spain

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Madrid, , Spain

Site Status RECRUITING

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Majadahonda, , Spain

Site Status RECRUITING

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Seville, , Spain

Site Status RECRUITING

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Seville, , Spain

Site Status NOT_YET_RECRUITING

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Seville, , Spain

Site Status RECRUITING

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Valencia, , Spain

Site Status RECRUITING

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Alingsås, , Sweden

Site Status WITHDRAWN

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Gothenburg, , Sweden

Site Status RECRUITING

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Jönköping, , Sweden

Site Status RECRUITING

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Karlstad, , Sweden

Site Status RECRUITING

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Mölndal, , Sweden

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Stockholm, , Sweden

Site Status RECRUITING

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Stockholm, , Sweden

Site Status RECRUITING

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Stockholm, , Sweden

Site Status RECRUITING

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Stockholm, , Sweden

Site Status NOT_YET_RECRUITING

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Uppsala, , Sweden

Site Status RECRUITING

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Västerås, , Sweden

Site Status RECRUITING

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Changhua, , Taiwan

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Kaohsiung City, , Taiwan

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Kaohsiung City, , Taiwan

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New Taipei City, , Taiwan

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New Taipei City, , Taiwan

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New Taipei City, , Taiwan

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Taichung, , Taiwan

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Taichung, , Taiwan

Site Status RECRUITING

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Taichung, , Taiwan

Site Status RECRUITING

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Taipei, , Taiwan

Site Status RECRUITING

Research Site

Taipei, , Taiwan

Site Status RECRUITING

Research Site

Taipei, , Taiwan

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Taipei, , Taiwan

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Research Site

Taipei, , Taiwan

Site Status RECRUITING

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Taipei, , Taiwan

Site Status RECRUITING

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Taipei, , Taiwan

Site Status RECRUITING

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Taoyuan District, , Taiwan

Site Status RECRUITING

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Yilan, , Taiwan

Site Status RECRUITING

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Yung Kang City, , Taiwan

Site Status RECRUITING

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Bangkok, , Thailand

Site Status RECRUITING

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Bangkok, , Thailand

Site Status RECRUITING

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Bangkok, , Thailand

Site Status RECRUITING

Research Site

Chiang Mai, , Thailand

Site Status RECRUITING

Research Site

Hat Yai, , Thailand

Site Status RECRUITING

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Khon Kaen, , Thailand

Site Status RECRUITING

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Naimuang, , Thailand

Site Status RECRUITING

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Pathum Thani, , Thailand

Site Status RECRUITING

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Adana, , Turkey (Türkiye)

Site Status RECRUITING

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Ankara, , Turkey (Türkiye)

Site Status RECRUITING

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Antalya, , Turkey (Türkiye)

Site Status RECRUITING

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Antalya, , Turkey (Türkiye)

Site Status RECRUITING

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Bursa, , Turkey (Türkiye)

Site Status COMPLETED

Research Site

Dinar, , Turkey (Türkiye)

Site Status RECRUITING

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Eskişehir, , Turkey (Türkiye)

Site Status RECRUITING

Research Site

Istanbul, , Turkey (Türkiye)

Site Status WITHDRAWN

Research Site

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Research Site

Kocaeli, , Turkey (Türkiye)

Site Status RECRUITING

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Kütahya, , Turkey (Türkiye)

Site Status RECRUITING

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Merkez, , Turkey (Türkiye)

Site Status RECRUITING

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Muğla, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Research Site

Sivas, , Turkey (Türkiye)

Site Status RECRUITING

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Chernivtsі, , Ukraine

Site Status RECRUITING

Research Site

Ivano-Frankivsk, , Ukraine

Site Status RECRUITING

Research Site

Kyiv, , Ukraine

Site Status RECRUITING

Research Site

Kyiv, , Ukraine

Site Status RECRUITING

Research Site

Kyiv, , Ukraine

Site Status RECRUITING

Research Site

Kyiv, , Ukraine

Site Status RECRUITING

Research Site

Kyiv, , Ukraine

Site Status RECRUITING

Research Site

Kyiv, , Ukraine

Site Status RECRUITING

Research Site

Ternopil, , Ukraine

Site Status RECRUITING

Research Site

Ternopil, , Ukraine

Site Status RECRUITING

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Uzhhorod, , Ukraine

Site Status RECRUITING

Research Site

Vinnytsia, , Ukraine

Site Status RECRUITING

Research Site

Vinnytsia, , Ukraine

Site Status RECRUITING

Research Site

Zhytomyr, , Ukraine

Site Status RECRUITING

Research Site

Airdrie, , United Kingdom

Site Status RECRUITING

Research Site

Barnet, , United Kingdom

Site Status RECRUITING

Research Site

Cambridge, , United Kingdom

Site Status WITHDRAWN

Research Site

Clydebank, , United Kingdom

Site Status RECRUITING

Research Site

Exeter, , United Kingdom

Site Status RECRUITING

Research Site

Harefield, , United Kingdom

Site Status RECRUITING

Research Site

Hastings, , United Kingdom

Site Status RECRUITING

Research Site

High Wycombe, , United Kingdom

Site Status WITHDRAWN

Research Site

Kent, , United Kingdom

Site Status RECRUITING

Research Site

Kings Lynn, , United Kingdom

Site Status RECRUITING

Research Site

Lincoln, , United Kingdom

Site Status WITHDRAWN

Research Site

London, , United Kingdom

Site Status COMPLETED

Research Site

London, , United Kingdom

Site Status WITHDRAWN

Research Site

Middlesbrough, , United Kingdom

Site Status RECRUITING

Research Site

Portsmouth, , United Kingdom

Site Status RECRUITING

Research Site

Sheffield, , United Kingdom

Site Status WITHDRAWN

Research Site

Sunderland, , United Kingdom

Site Status RECRUITING

Research Site

Wakefield, , United Kingdom

Site Status RECRUITING

Research Site

Can Tho, , Vietnam

Site Status RECRUITING

Research Site

Da Nang, , Vietnam

Site Status RECRUITING

Research Site

Haiphong, , Vietnam

Site Status RECRUITING

Research Site

Hanoi, , Vietnam

Site Status RECRUITING

Research Site

Hà Nội, , Vietnam

Site Status RECRUITING

Research Site

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Research Site

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Research Site

Hochiminh City, , Vietnam

Site Status RECRUITING

Research Site

Hochiminh, , Vietnam

Site Status RECRUITING

Research Site

Hồ Chí Minh, , Vietnam

Site Status RECRUITING

Research Site

Huế, , Vietnam

Site Status RECRUITING

Countries

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United States Argentina Australia Austria Brazil Bulgaria Canada Chile China Colombia Czechia Finland France Germany Greece Hungary India Israel Italy Japan Malaysia Mexico Netherlands Peru Philippines Poland Romania Saudi Arabia Slovakia South Africa South Korea Spain Sweden Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom Vietnam

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

Bhattacharya CS, Ericsson H, Johansson S, Parkinson J, Boca SM, Yang Y, Heijer M, Housler G, Leonsson-Zachrisson M, Hartleib-Geschwindner J, Pizzato PE. The effect of severe renal impairment on the pharmacokinetics, safety and tolerability of balcinrenone. Br J Clin Pharmacol. 2025 Jul;91(7):1937-1946. doi: 10.1002/bcp.70017. Epub 2025 Feb 17.

Reference Type DERIVED
PMID: 39962632 (View on PubMed)

Other Identifiers

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2023-508162-15-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

D6402C00012

Identifier Type: -

Identifier Source: org_study_id