Study Stopped
Due to potential concerns about liver safety (See Detailed Description)
Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects With Type 2 Diabetes and With Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events
9 other identifiers
interventional
3,207
32 countries
584
Brief Summary
The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite events exists following long term treatment with TAK-875 compared with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Jun 2012
Typical duration for phase_3 type-2-diabetes
584 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2012
CompletedFirst Posted
Study publicly available on registry
June 1, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
August 21, 2015
CompletedOctober 19, 2015
October 1, 2015
1.9 years
May 29, 2012
July 24, 2015
October 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite
The time from randomization to the first occurrences of any event in the primary MACE composite was evaluated using Kaplan-Meier analysis. The primary MACE composite comprised cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization).
Baseline up to end of study (up to Day 588)
Secondary Outcomes (1)
Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite
Baseline up to end of study (up to Day 588)
Study Arms (2)
TAK-875 50 mg
EXPERIMENTALTAK-875 50 mg tablets, orally, once daily for up to 6 years.
Placebo
PLACEBO COMPARATORTAK-875 placebo-matching tablets, orally, once daily for up to 6 years.
Interventions
Eligibility Criteria
You may qualify if:
- In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements, including scheduled clinic appointments.
- The patient or, when applicable, the patient's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Has a diagnosis of type 2 diabetes mellitus.
- Has an glycosylated hemoglobin (HbA1c) level between 7.0% and 10.5%, inclusive, at Screening. HbA1c testing may be repeated once during Screening.
- Meets at least one (1) of the following three (3) High Risk Categories (a-c ):
- A documented history of myocardial infarction (MI) occurring no less than 2 months (60 days) and no greater than 24 months prior to Screening.
- Documented symptomatic peripheral arterial disease (PAD) (at least one (1) of the following three (3) criteria must be satisfied): i) Current intermittent claudication together with documented ankle-brachial index ≤0.85. ii) History of previous vascular intervention for intermittent claudication or resting limb ischemia (example: amputation for arterial disease, peripheral bypass, or history of angioplasty/stenting). iii) History of symptomatic carotid artery disease (requiring revascularization with carotid endarterectomy (CEA) or stenting).
- Documented cerebrovascular disease (at least one (1) of the following two (2) criteria must be satisfied): i) A history of transient ischemic attack (TIA) confirmed by a neurologist no greater than 24 months prior to screening and clinically and neurologically stable at randomization. ii) A history of ischemic stroke (IS) (with a Modified Rankin Scale Score ≤3 documented prior to Randomization) not less than 2 months (60 days) and no greater than 24 months prior to Screening, and clinically and neurologically stable at Randomization. The Modified Rankin Scale is located in appendix in protocol.
- Or meets at least one (1) of the following five (5) Intermediate Risk Categories (d-h):
- Stable angina with coronary disease documented by the presence of inducible ischemia or scar by stress myocardial perfusion imaging (MPI), echocardiogram or magnetic resonance imaging (MRI) in the past 24 months.
- Multi vessel coronary disease, based on coronary angiography, with or without angina, documented by \>50% diameter stenosis in at least 2 of the 3 major coronary distributions.
- A history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at least 2 months prior to Screening.
- The subject has diabetic nephropathy plus (2) of the clinical criteria listed below (i. to vi.). Diabetic nephropathy is defined as either urinary albumin excretion ≥ 30 µg/mg creatinine (3.4 mg/mmol creatinine) (based on a random spot collection) or urinary albumin excretion ≥ 30 mg/24h (based on a 24 h or timed collection). Results must be confirmed on at least two specimens collected within 12 months prior to Screening and no more than 6 months apart: i)Duration of diabetes ≥ 10 years on pharmacological treatment documented within medical records. ii) Confirmed systolic blood pressure (SBP) ≥150 mm Hg on 2 separate days during Screening despite treatment with at least 2 anti-hypertensive medications administered at doses considered optimal by local standard of care. iii) Presence of dyslipidemia as defined by any one (1) of the following confirmed at screening: A. Low density lipoprotein (LDL) \> 100 mg/dl (2.59 mmol/L) while on statin therapy administered at maximum tolerated dose or optimal dose based on local standard of care for at least 4 weeks prior to screening. B. LDL \> 130 mg/dL (3.37 mmol/L) when not on statin therapy. C. High density lipoprotein (HDL) \< 40 mg/dL (1.04 mmol/L) in males or \< 45 mg/dL (1.17 mmol/L) in females. D. Fasting Triglyceride \>200 mg/dL(2.26 mmol/L). iv) Currently smoking \>10 cigarettes per day at Screening. v) Male ≥65 years of age or female ≥70 years of age. vi) Highly selective C-reactive protein (hs-CRP) \> 2.0 mg/L in the absence of intercurrent infection or acute process.
- h.) The subject meets at least five (5) of the following clinical criteria: i.) Duration of diabetes ≥10 years on pharmacological treatment documented within medical records. ii) Confirmed systolic blood pressure (SBP) ≥150 mm Hg on 2 separate days during Screening despite treatment with at least 2 anti-hypertensive medications administered at doses considered optimal by local standard of care. iii) Presence of dyslipidemia as defined by any one (1) of the following confirmed at screening: A. Low density lipoprotein (LDL) \> 100 mg/dl (2.59 mmol/L) while on statin therapy administered at maximum tolerated dose or optimal dose based on local standard of care for at least 4 weeks prior to screening. B. LDL \> 130 mg/dL (3.37 mmol/L) when not on statin therapy. C. High density lipoprotein (HDL) \< 40 mg/dL (1.04 mmol/L) in males or \< 45 mg/dL (1.17 mmol/L) in females. D. Fasting Triglyceride \>200 mg/dL(2.26 mmol/L). iv) Currently smoking \>10 cigarettes per day at Screening. v) Male ≥65 years of age or female ≥70 years of age. vi) Highly selective C-reactive protein (hs-CRP) \> 2.0 mg/L in the absence of intercurrent infection or acute process.
- Is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations in patient diaries.
- +2 more criteria
You may not qualify if:
- Has received any investigational medication within 30 days prior to Screening or any investigational antidiabetic medication or excluded medications within 3 months prior to Screening.
- Has been randomized into a previous TAK-875 study.
- Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, biological or legally adopted child, or sibling) or may consent under duress
- Is diagnosed with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
- Is hemodynamically unstable, including severe heart failure (New York Heart Association Class IV) at Screening.
- Has ALT and/or AST levels \>3.0x ULN at Screening.
- Has a total bilirubin level \>ULN at Screening. Exception: if a patient has documented Gilbert's Syndrome, the patient will be allowed with an elevated bilirubin level per the investigator's discretion.
- Has an glomerular filtration rate (estimated) (eGFR) ≤ 15 mL/min/1.73m2 based on Modification of Diet in Renal Disease (MDRD) calculation at Screening and is currently on dialysis or expected to start dialysis within the next 6 months.
- Has uncontrolled thyroid disease, as determined by the investigator and/or clinical investigation.
- Has a known history of infection with human immunodeficiency virus (HIV).
- Has a known active infection with Hepatitis B virus (HBV), or Hepatitis C virus (HCV) requiring antiviral treatment.
- Has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within 2 years prior to Screening.
- Has any major illness or condition that, in the investigator's opinion, prohibits the patient from participating in the study or meeting the planned visit schedule.
- Has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to TAK-875.
- If female, is pregnant (confirmed by laboratory testing, ie, serum or urine human chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (584)
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Mobile, Alabama, United States
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Muscle Shoals, Alabama, United States
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Pell City, Alabama, United States
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Goodyear, Arizona, United States
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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El Cajon, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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La Mesa, California, United States
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Laguna Hills, California, United States
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Los Angeles, California, United States
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Mission Hills, California, United States
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National City, California, United States
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Newport Beach, California, United States
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Orange, California, United States
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Paramount, California, United States
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Pismo Beach, California, United States
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Redondo Beach, 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 Franciso, California, United States
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Stockton, California, United States
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Thousand Oaks, California, United States
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Torrance, California, United States
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Valley Village, California, United States
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Westlake Village, California, United States
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Denver, Colorado, United States
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Lakewood, Colorado, United States
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Bridgeport, Connecticut, United States
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Danbury, Connecticut, United States
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Seaford, Delaware, United States
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Washington D.C., District of Columbia, United States
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Boynton Beach, Florida, United States
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Brandon, Florida, United States
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Chipley, Florida, United States
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Clearwater, Florida, United States
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Cocoa, Florida, United States
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Coral Gables, Florida, United States
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Coral Springs, Florida, United States
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Crystal River, Florida, United States
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Delray Beach, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville Beach, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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North Miami Beach, Florida, United States
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Ocala, Florida, United States
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Oviedo, Florida, United States
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Pembroke Pines, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Trinity, Florida, United States
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Vero Bearch, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Calhoun, Georgia, United States
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Conyers, Georgia, United States
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Cumming, Georgia, United States
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Norcross, Georgia, United States
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Roswell, Georgia, United States
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Suwanee, Georgia, United States
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Woodstock, Georgia, United States
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Chicago, Illinois, United States
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LaGrange, Illinois, United States
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Springfield, Illinois, United States
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Anderson, Indiana, United States
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Avon, Indiana, United States
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Elkhart, Indiana, United States
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Greenfield, Indiana, United States
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Indianapolis, Indiana, United States
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Muncie, Indiana, United States
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Ames, Iowa, United States
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Council Bluffs, Iowa, United States
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Waterloo, Iowa, United States
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Augusta, Kansas, United States
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Hutchinson, Kansas, United States
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Newton, Kansas, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Elizabethtown, Kentucky, United States
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Marrero, Louisiana, United States
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Monroe, Louisiana, United States
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Natchitoches, Louisiana, United States
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New Orleans, Louisiana, United States
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Sherveport, Louisiana, United States
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Portland, Maine, United States
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Annapolis, Maryland, United States
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Balitmore, Maryland, United States
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Baltimore, Maryland, United States
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Fall River, Massachusetts, United States
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Hyannis, Massachusetts, United States
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Natick, Massachusetts, United States
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Springfield, Massachusetts, United States
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Bay City, Michigan, United States
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Cadillac, Michigan, United States
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Flint, Michigan, United States
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Kalamazoo, Michigan, United States
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Mount Clemens, Michigan, United States
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Novi, Michigan, United States
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Pontiac, Michigan, United States
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Saginaw, Michigan, United States
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Troy, Michigan, United States
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Baxter, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Saint Paul, Minnesota, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Nashua, New Hampshire, United States
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Bridgewater, New Jersey, United States
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Elizabeth, New Jersey, United States
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Haddon Heights, New Jersey, United States
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Linden, New Jersey, United States
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Mine Hill, New Jersey, United States
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Somerset, New Jersey, United States
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South Plainfield, New Jersey, United States
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Toms Rivers, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Saratoga Springs, New York, United States
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Smithtown, New York, United States
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Syracuse, New York, United States
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Burlington, North Carolina, United States
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Calabash, 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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Hickory, North Carolina, United States
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Lenoir, North Carolina, United States
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Mooresville, North Carolina, United States
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Morganton, North Carolina, United States
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Raleigh, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Fairview Park, Ohio, United States
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Gallipolis, Ohio, United States
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Kettering, Ohio, United States
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Marion, Ohio, United States
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Middleburg Heights, Ohio, United States
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Perrysburg, Ohio, United States
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Springfield, Ohio, United States
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Toledo, Ohio, United States
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Willoughby Hills, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Chambersburg, Pennsylvania, United States
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Hanleysville, Pennsylvania, United States
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Harleysville, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphi, Pennsylvania, United States
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Scotland, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Pawtucket, Rhode Island, United States
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Columbia, South Carolina, United States
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Greer, South Carolina, United States
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Laurens, South Carolina, United States
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Simpsonville, South Carolina, United States
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Bristol, Tennessee, United States
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Crossville, Tennessee, United States
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Jackson, Tennessee, United States
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Kingsport, Tennessee, United States
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Nashville, Tennessee, United States
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Oak Ridge, Tennessee, United States
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Tullahoma, Tennessee, United States
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Austin, Texas, United States
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Carrollton, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Katy, Texas, United States
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Midland, 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
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Spring, Texas, United States
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Tomball, Texas, United States
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Victoria, Texas, United States
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Bountiful, Utah, United States
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Layton, Utah, United States
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Salt Lake City, Utah, United States
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Alexandria, Virginia, United States
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Danville, Virginia, United States
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Falls Church, Virginia, United States
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Hampton, Virginia, United States
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Manassas, Virginia, United States
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Wenatchee, Washington, United States
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Huntington, West Virginia, United States
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Lewisburg, West Virginia, United States
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La Crosse, Wisconsin, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Wauwatosa, Wisconsin, United States
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Bahía Blanca, Buenos Aires, Argentina
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Haedo, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Loma Hermosa, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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San Nicolás de los Arroyos, Buenos Aires, Argentina
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Zárate, Buenos Aires, Argentina
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Trelew, Chubut Province, Argentina
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Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
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Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
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Corrientes, Corrientes Province, Argentina
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Córdoba, Córdoba Province, Argentina
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Villa Cabrera, Córdoba Province, Argentina
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Villa María, Córdoba Province, Argentina
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San Salvador de Jujuy, Jujy, Argentina
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Godoy Cruz, Mendoza Province, Argentina
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Mendoza, Mendoza Province, Argentina
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Cipolletti, Río Negro Province, Argentina
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Salta, Salta Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Venado Tuerto, Santa Fe Province, Argentina
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Santiago del Estero, Santiago del Estero Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Córdoba, Argentina
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Rosario, Argentina
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Bruce, Australian Capital Territory, Australia
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Canberra, Australian Capital Territory, Australia
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Garran, Australian Capital Territory, Australia
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Westmead, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Brisbane, Queensland, Australia
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Meadowbrook, Queensland, Australia
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Milton, Queensland, Australia
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Townsville, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Adelaide, South Australia, Australia
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Daw Park, South Australia, Australia
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Elizabeth Vale, South Australia, Australia
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Clayton, Victoria, Australia
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Fitzroy, Victoria, Australia
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Geelong, Victoria, Australia
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Melbourne, Victoria, Australia
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Sale, Victoria, Australia
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Joondalup, Western Australia, Australia
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Bruce, Australia
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Garran, Australia
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Fortaleza, Ceará, Brazil
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Brasília, Federal District, Brazil
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Goiânia, Goiás, Brazil
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Campina Grande do Sul, Paraná, Brazil
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Curitiba, Paraná, Brazil
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Belém, Pará, Brazil
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Recife, Pernambuco, Brazil
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Canoas, Rio Grande do Sul, Brazil
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Caxias do Sul, Rio Grande do Sul, Brazil
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Passo Fundo, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Santa Maria, Rio Grande do Sul, Brazil
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Marília, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Blagoevgrad, Bulgaria
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Byala, Bulgaria
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Kazanlak, Bulgaria
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Pazardzhik, Bulgaria
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Plovdiv, Bulgaria
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Sevlievo, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Calgary, Alberta, Canada
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Spruce Grove, Alberta, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Brampton, Ontario, Canada
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Etobicoke, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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Markham, Ontario, Canada
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Oakville, Ontario, Canada
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Ottawa, Ontario, Canada
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Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
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Gatineau, Quebec, Canada
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Laval, Quebec, Canada
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Longueuil, Quebec, Canada
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Montreal, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Saint-Laurent, Quebec, Canada
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Čakovec, Croatia
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Karlovac, Croatia
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Koprivnica, Croatia
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Krapinske Toplice, Croatia
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Osijek, Croatia
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Rijeka, Croatia
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Sisak, Croatia
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Slavonski Brod, Croatia
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Split, Croatia
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Virovitica, Croatia
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Zadar, Croatia
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Zagreb, Croatia
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Choceň, Czechia
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České Budějovice, Czechia
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Jindřichův Hradec, Czechia
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Kroměříž, Czechia
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Mariánské Lázně, Czechia
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Moravský Krumlov, Czechia
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Olomouc, Czechia
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Ostrava, Czechia
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Ostrava - Moravska Ostrava, Czechia
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Ostrava - Vitkovice, Czechia
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Prague, Czechia
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Praha 4 - Krc, Czechia
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Slaný, Czechia
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Trutnov, Czechia
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Ústí nad Labem, Czechia
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Paide, Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Corbeil Essonne, Essonne, France
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Corbeil-Essonnes, Essonne, France
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Pessac, Gironde, France
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Nanterre, Hauts de Seine, France
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Nantes, Loire Atlantique, France
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Paris, Paris, France
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Pierre-Bénite, Rhone, France
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Friedrichstal, Baden-Wurttemberg, Germany
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Falkensee, Brandenburg, Germany
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Hamburg, Hamburg, Germany
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Kelkheim, Hesse, Germany
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Cologne, North Rhine-Westphalia, Germany
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Dortmund, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Goch, North Rhine-Westphalia, Germany
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Kamp-Lintfort, North Rhine-Westphalia, Germany
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Bad Kreuznach, Rhineland-Palatinate, Germany
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Dippoldiswalde, Saxony, Germany
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Dresden, Saxony, Germany
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Hohenmölsen, Saxony-Anhalt, Germany
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Berlin, State of Berlin, Germany
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Hong Kong, Hong Kong
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New Territories, Hong Kong
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Baja, Hungary
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Balatonfüred, Hungary
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Budaörs, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Eger, Hungary
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Gödöllő, Hungary
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Gyula, Hungary
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Kecskemét, Hungary
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Kistelek, Hungary
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Komárom, Hungary
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Makó, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Szekszárd, Hungary
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Szikszó, Hungary
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Szombathely, Hungary
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Úrhida, Hungary
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Veszprém, Hungary
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Zalaegerszeg, Hungary
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Ashkelon, Israel
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Beer Yaakov, Israel
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Beersheba, Israel
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Giv‘atayim, Israel
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Hadera, 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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Petah Tikva, Israel
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Raanana, Israel
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Safed, Israel
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Tel Aviv, Israel
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Florence, Firenze, Italy
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Milan, Milano, Italy
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San Donato Milanese, Milano, Italy
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Sesto San Giovanni, Milano, Italy
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Pavia, Pavia, Italy
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Daugavpils, Latvia
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Jelgava, Latvia
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Limbaži, Latvia
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Ogre, Latvia
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Riga, Latvia
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Talsi, Latvia
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Valmiera, Latvia
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Alytus, Lithuania
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Kaunas, Lithuania
Unknown Facility
Klaipėda, Lithuania
Unknown Facility
Johor Bahru, Johor, Malaysia
Unknown Facility
Alor Star, Kedah, Malaysia
Unknown Facility
Kelantan, Kelantan, Malaysia
Unknown Facility
Kota Bharu, Kelantan, Malaysia
Unknown Facility
Kuala Lumpur, Kuala Lumpur, Malaysia
Unknown Facility
Lembah Pantai, Kuala Lumpur, Malaysia
Unknown Facility
Malacca, Melaka, Malaysia
Unknown Facility
Ipoh, Perak, Malaysia
Unknown Facility
Taiping, Perak, Malaysia
Unknown Facility
Taiping, Perak, Perak, Malaysia
Unknown Facility
Kuala Selangor, Selangor, Malaysia
Unknown Facility
Petaling Jaya, Selangor, Malaysia
Unknown Facility
Terengganu, Terengganu, Malaysia
Unknown Facility
Kuala Selangor, Malaysia
Unknown Facility
Terengganu, Malaysia
Unknown Facility
Aguascalientes, Aguascalientes, Mexico
Unknown Facility
Tijuana, Baja California Norte, Mexico
Unknown Facility
Chihuahua City, Chihuahua, Mexico
Unknown Facility
Torreón, Coahuila, Mexico
Unknown Facility
Durango, Durango, Mexico
Unknown Facility
Acapulco de Juárez, Guerrero, Mexico
Unknown Facility
Pachuca, Hidalgo, Mexico
Unknown Facility
Guadalajara, Jalisco, Mexico
Unknown Facility
Zapopan, Jalisco, Mexico
Unknown Facility
Cuauhtémoc, Mexico City, Mexico
Unknown Facility
Mexico City, Mexico City, Mexico
Unknown Facility
Morelia, Michoacán, Mexico
Unknown Facility
Cuernavaca, Morelos, Mexico
Unknown Facility
Monterrey, Nuevo Le=n, Mexico
Unknown Facility
Monterrey, Nuevo León, Mexico
Unknown Facility
San Luis Potosí City, San Luis Potos, Mexico
Unknown Facility
Culiacán, Sinaloa, Mexico
Unknown Facility
Cuautitlán Izcalli, State of Mexico, Mexico
Unknown Facility
Metepec, State of Mexico, Mexico
Unknown Facility
Tamaulipas, Tamaulipas, Mexico
Unknown Facility
Xalapa, Veracruz, Mexico
Unknown Facility
Mérida, Yucatán, Mexico
Unknown Facility
Auckland, New Zealand
Unknown Facility
Christchurch, New Zealand
Unknown Facility
Dunedin, New Zealand
Unknown Facility
Palmerston North, New Zealand
Unknown Facility
Tauranga, New Zealand
Unknown Facility
Wellington, New Zealand
Unknown Facility
Callao, Peru
Unknown Facility
Cusco, Peru
Unknown Facility
Huacho, Peru
Unknown Facility
Ica, Peru
Unknown Facility
La Libertad, Peru
Unknown Facility
Lima, Peru
Unknown Facility
Piura, Peru
Unknown Facility
Baguio City, Philippines
Unknown Facility
Cebu City, Philippines
Unknown Facility
Dasmariñas City, Cavite, Philippines
Unknown Facility
Davao City, Philippines
Unknown Facility
Iloilo City, Philippines
Unknown Facility
Marikina City, Philippines
Unknown Facility
Quezon City, Philippines
Unknown Facility
Tarlac City, Philippines
Unknown Facility
Taytay, Philippines
Unknown Facility
Bialystok, Poland
Unknown Facility
Gdansk, Poland
Unknown Facility
Gliwice, Poland
Unknown Facility
Grodzisk Mazowiecki, Poland
Unknown Facility
Kamieniec Ząbkowicki, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Oświęcim, Poland
Unknown Facility
Parczew, Poland
Unknown Facility
Poznan, Poland
Unknown Facility
Puławy, Poland
Unknown Facility
Radom, Poland
Unknown Facility
Ruda Śląska, Poland
Unknown Facility
Rzeszów, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Wroclaw, Poland
Unknown Facility
Łęczyca, Poland
Unknown Facility
Bacau, Romania
Unknown Facility
Baia Mare, Romania
Unknown Facility
Brasov, Romania
Unknown Facility
Bucharest, Romania
Unknown Facility
Galati, Romania
Unknown Facility
Iași, Romania
Unknown Facility
Oradea, Romania
Unknown Facility
Ploieşti, Romania
Unknown Facility
Târgu Mureş, Romania
Unknown Facility
Timișoara, Romania
Unknown Facility
Arkhangelsk, Russia
Unknown Facility
Barnaul, Russia
Unknown Facility
Kazan', Russia
Unknown Facility
Kemerovo, Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Nizhny Novgorod, Russia
Unknown Facility
Novosibirsk, Russia
Unknown Facility
Pushkin, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Saratov, Russia
Unknown Facility
Yaroslavl, Russia
Unknown Facility
Bratislava, Slovakia
Unknown Facility
Komárno, Slovakia
Unknown Facility
Košice, Slovakia
Unknown Facility
Levice, Slovakia
Unknown Facility
Lučenec, Slovakia
Unknown Facility
Martin, Slovakia
Unknown Facility
Nitra, Slovakia
Unknown Facility
Nové Mesto nad Váhom, Slovakia
Unknown Facility
Prešov, Slovakia
Unknown Facility
Svidník, Slovakia
Unknown Facility
Šahy, Slovakia
Unknown Facility
Trenčín, Slovakia
Unknown Facility
Žilina, Slovakia
Unknown Facility
Port Elizabeth, Eastern Cape, South Africa
Unknown Facility
Bloemfontein, Free State, South Africa
Unknown Facility
Johannesburg, Gauteng, South Africa
Unknown Facility
Kempton Park, Gauteng, South Africa
Unknown Facility
Krugersdorp, Gauteng, South Africa
Unknown Facility
Lenasia, Gauteng, South Africa
Unknown Facility
Pretoria, Gauteng, South Africa
Unknown Facility
Durban, KwaZulu-Natal, South Africa
Unknown Facility
Cape Town, Western Cape, South Africa
Unknown Facility
Stellenbosch, Western Cape, South Africa
Unknown Facility
Worcester, Western Cape, South Africa
Unknown Facility
Wŏnju, Gangwon-do, South Korea
Unknown Facility
Seongnam-si, Gyeonggi-do, South Korea
Unknown Facility
Yangsan, Gyeongsangnam-do, South Korea
Unknown Facility
Jeonju, Jeollabuk-do, South Korea
Unknown Facility
Busan, South Korea
Unknown Facility
Gyeonggi-do, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Douliu, Taiwan
Unknown Facility
Kaohsiung City, Taiwan
Unknown Facility
New Taipei City, Taiwan
Unknown Facility
Taichung, Taiwan
Unknown Facility
Tainan, Taiwan
Unknown Facility
Taipei, Taiwan
Unknown Facility
Bangkoknoi, Bangkok, Thailand
Unknown Facility
Dusit, Bangkok, Thailand
Unknown Facility
Patumwan, Bangkok, Thailand
Unknown Facility
Rachathevi, Bangkok, Thailand
Unknown Facility
Rajtevi, Bangkok, Thailand
Unknown Facility
Ratchathewi, Bangkok, Thailand
Unknown Facility
Muang, Changwat Chiang Rai, Thailand
Unknown Facility
Muang, Changwat Khon Kaen, Thailand
Unknown Facility
Muang, Changwat Nakhon Ratchasima, Thailand
Unknown Facility
Muang, Chiang Mai, Thailand
Unknown Facility
Donetsk, Ukraine
Unknown Facility
Kharkiv, Ukraine
Unknown Facility
Kyiv, Ukraine
Unknown Facility
Luhansk, Ukraine
Unknown Facility
Mykolayiv, Ukraine
Unknown Facility
Odesa, Ukraine
Unknown Facility
Poltava, Ukraine
Unknown Facility
Simferopol, Ukraine
Unknown Facility
Ternopil, Ukraine
Unknown Facility
Vinnycia, Ukraine
Unknown Facility
Vinnytsia, Ukraine
Unknown Facility
Zaporizhzhia, Ukraine
Unknown Facility
Cardiff, Cardiff, United Kingdom
Unknown Facility
Truro, Cornwall, United Kingdom
Unknown Facility
Exeter, Devon, United Kingdom
Unknown Facility
Plymouth, Devon, United Kingdom
Unknown Facility
Torquay, Devon, United Kingdom
Unknown Facility
Hull, East Riding of Yorkshire, United Kingdom
Unknown Facility
Bexhill-on-Sea, East Sussex, United Kingdom
Unknown Facility
Portsmouth, Hampshire, United Kingdom
Unknown Facility
Watford, Hertfordshire, United Kingdom
Unknown Facility
Gillingham, Kent, United Kingdom
Unknown Facility
Thornton-Cleveleys, Lancashire, United Kingdom
Unknown Facility
Leicester, Leicestershire, United Kingdom
Unknown Facility
Liverpool, Merseyside, United Kingdom
Unknown Facility
Harrow, Middlesex, United Kingdom
Unknown Facility
Northwood, Middlesex, United Kingdom
Unknown Facility
Stoke-on-Trent, Staffordshire, United Kingdom
Unknown Facility
Swansea, West Glamorgan, United Kingdom
Related Publications (2)
Shavadia JS, Sharma A, Gu X, Neaton J, DeLeve L, Holmes D, Home P, Eckel RH, Watkins PB, Granger CB. Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program. Clin Trials. 2019 Jun;16(3):253-262. doi: 10.1177/1740774519836766. Epub 2019 Mar 18.
PMID: 30880443DERIVEDMenon V, Lincoff AM, Nicholls SJ, Jasper S, Wolski K, McGuire DK, Mehta CR, Rosenstock J, Lopez C, Marcinak J, Cao C, Nissen SE; GRAND 306 Investigators. Fasiglifam-Induced Liver Injury in Patients With Type 2 Diabetes: Results of a Randomized Controlled Cardiovascular Outcomes Safety Trial. Diabetes Care. 2018 Dec;41(12):2603-2609. doi: 10.2337/dc18-0755.
PMID: 30459247DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Sr. Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2012
First Posted
June 1, 2012
Study Start
June 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
October 19, 2015
Results First Posted
August 21, 2015
Record last verified: 2015-10