Trial Condition(s):

Carcinoma, Renal Cell

Treatment Protocol for the use of Sorafenib in Patients with Advanced Renal Cell Carcinoma

Bayer Identifier:

11868

ClinicalTrials.gov Identifier:

NCT00111020

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial in which sorafenib is compared to another equal treatment. All patients in this protocol will be treated with sorafenib. In addition, data from the patients who participate in this protocol will provide additional information about the drug.

Inclusion Criteria
- Patients with advanced (unresectable, recurrent or metastatic) RCC
 - Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy 
 - Patients with an ECOG performance status of 0-2 
 - Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib  
 - Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice
Exclusion Criteria
- Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial
 - Patients who have participated in any other sorafenib trial
 - Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry
 - Life expectancy of less than two months
 - Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0
 - Patients with active coronary artery disease or ischemia
 - Patients with Child-Pugh class C hepatic impairment
 - Patients with severe renal impairment or who require dialysis
 - Patients with active uncontrolled hypertension
 - Patients with recent or active bleeding diathesis

Trial Summary

Enrollment Goal
2567
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Glens Falls, United States, 12801

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Montreal, Canada, H2W 1S6

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Weston, United States, 33331

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New Haven, United States, 6520

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Peoria, United States, 61615

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Marshfield, United States, 54449

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Harrisburg, United States, 17111

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Ogden, United States, 84403

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Baton Rouge, United States, 70809

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Pensacola, United States, 32501

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North Charleston, United States, 29406

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San Antonio, United States, 78229

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Milwaukee, United States, 53226

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Philadelphia, United States, 19114

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Nashville, United States, 37203

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Loma Linda, United States, 92357

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Temple, United States, 76502

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Greenville, United States, 27834

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Seattle, United States, 98101

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Green Bay, United States, 54301

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Baltimore, United States, 21204

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Minneapolis, United States, 55455

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St Louis Park, United States, 55416

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Hackensack, United States, 7601

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Aurora, United States, 80045 

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East Orange, United States, 7018

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Chapel Hill, United States, 27599

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Springfield, United States, 1104

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Vallejo, United States, 94589

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Fountain Valley, United States, 92708

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Olathe, United States, 66061

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TAMC, United States, 96859

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Lawton, United States, 73505

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Dallas, United States, 75230

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New Brunswick, United States, 08902

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Fargo, United States, 58122

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Madison, United States, 53715

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Hermitage, United States, 16148

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Chicago, United States, 60637

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Rancho Mirage, United States, 92270

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St Joseph, United States, 64507

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Monongahela, United States, 15063

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Cullman, United States, 35058

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Goshen, United States, 46526

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Canton, United States, 44710

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Midwest City, United States, 73110

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Fargo, United States, 58108

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Utica, United States, 13502

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Arlington, United States, 76012

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Huntington, United States, 25702

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Springfield, United States, 62701

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Lakeland, United States, 33805

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Salt Lake City, United States, 84112

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Las Vegas, United States, 89109

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Fort Myers, United States, 33901

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San Antonio, United States, 78212

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Dayton, United States, 45429

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Jamaica, United States, 11432

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Daytona Beach, United States, 32114

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Richmond, United States, 23294

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Chevy Chase, United States, 20815

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Las Vegas, United States, 89106 

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St Louis Park, United States, 55426

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Beech Grove, United States, 46107

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Hot Springs, United States, 71913

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Greenwich, United States, 06830

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Charlotte, United States, 28204

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Colorado Springs, United States, 80907

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Missoula, United States, 59807

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Lancaster, United States, 17604

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Springdale, United States, 72764

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MT Clemens, United States, 48043

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Newark, United States, 07112

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Middletown, United States, 45042

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Bakersfield, United States, 93309

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Portsmouth, United States, 03801

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Bismarck, United States, 58501

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Milford, United States, 01757

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Philadelphia, United States, 19111

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Columbus, United States, 43214

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San Diego, United States, 92120

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Los Angeles, United States, 90033

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St Louis, United States, 63110

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Memphis, United States, 38120

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Detroit, United States, 48202

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East Stroudsburg, United States, 18301

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Denver, United States, 80210

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Hutchinson, United States, 67502

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Stony Brook, United States, 11794

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Albuquerque, United States, 87106

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Charleston, United States, 29403

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New York, United States, 10021

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Fort Worth, United States, 76104

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Cedar Rapids, United States, 52402

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Clinton Township, United States, 48038

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Baltimore, United States, 21237

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Marquette, United States, 49855

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Sunnyvale, United States, 94086

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Concord, United States, 94520

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Bronx, United States, 10469

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Lynchburg, United States, 24501

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Columbus, United States, 31904

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Lawrence, United States, 66044

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Charleston, United States, 25304

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Dallas, United States, 75237

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Bend, United States, 97701

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Clinton, United States, 20735

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Lincoln, United States, 68506

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Baltimore, United States, 21239

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Detroit, United States, 48201

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La Jolla, United States, 92093

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Charlottesville, United States, 22908

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Clarksville, United States, 37043

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Poughkeepsie, United States, 12601

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Columbus, United States, 43235

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Columbus, United States, 43213

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New York, United States, 10032

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Pottsville, United States, 17901

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Houma, United States, 70360

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Setauket, United States, 11733

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Lafayette, United States, 80026

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Dunmore, United States, 18512

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Memphis, United States, 38119

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Armonk, United States, 10504

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Rockville, United States, 20850

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State College, United States, 16803

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Austin, United States, 78705

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York, United States, 17403

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La Jolla, United States, 92037

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Newport Beach, United States, 92663

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Orange, United States, 92868

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Los Angeles, United States, 90025

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Lincoln, United States, 68510

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Pensacola, United States, 32514

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Burlington, United States, 27215

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Urbana, United States, 61801

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Glendale, United States, 53212

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Salinas, United States, 93901

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Cooperstown, United States, 13326

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Williamsville, United States, 14221

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Tyler, United States, 75701

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Mayfield Heights, United States, 44124

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St Petersburg, United States, 33705

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Indianapolis, United States, 46256

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Wausau, United States, 54401

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Tucson, United States, 85704

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Bayshore, United States, 11706

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Albuquerque, United States, 87108

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Rochester, United States, 14642

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Gainesville, United States, 32610

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Boca Raton, United States, 33486

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Bennington, United States, 5201

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Seattle, United States, 98104

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Muskegon, United States, 49443

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Bethlehem, United States, 18015

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St Louis, United States, 63136

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Indianapolis, United States, 46254

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Dubuqe, United States, 52001

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Laporte, United States, 46350

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Duluth, United States, 55805

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Albany, United States, 31701

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Stuart, United States, 34994

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Kinston, United States, 28501

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South Bend, United States, 46601

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Chicago, United States, 60640

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Anchorage, United States, 99508

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Miami, United States, 33136

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Miami Beach, United States, 33140

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Springfield, United States, 65804

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Scottsdale, United States, 85258

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Jamaica Plain, United States, 2130

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New York, United States, 10016

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Bangor, United States, 4401

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Toronto, Canada, M5G 2M9

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London, Canada, N6A 4L6

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Toronto, Canada, M4N 3M5

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Edmonton, Canada, T6G 1Z2

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Hamilton, Canada, L8V 5C2

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Halifax, Canada, B3H 2Y9

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Winnipeg, Canada, R3E 0V9

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Richmond, United States, 23230

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Canton, United States, 44718 

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Little Rock, United States, 72205

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Lebanon, United States, 03766

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Hartford, United States, 06105

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Metairie, United States, 70006

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Atlanta, United States, 30309

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Augusta, United States, 30901

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Orlando, United States, 32806

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Beverly, United States, 90211

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Ormond Beach, United States, 32174

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Macon, United States, 31201

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Ocala, United States, 34474

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Latham, United States, 12110

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Wynnewood, United States, 19096

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Pine Bluff, United States, 71603

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Glendale, United States, 85304

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Stamford, United States, 06902

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Mobile, United States, 36608

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Houston, United States, 77024

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Annapolis, United States, 21401

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Louisville, United States, 40292

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Portland, United States, 97213

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Middletown, United States, 06457

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Stanford, United States, 94305

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Bronx, United States, 10466

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Joliet, United States, 60432

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Portland, United States, 97239

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Decatur, United States, 62526

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Scarborough, United States, 04074

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Council Bluffs, United States, 51503

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East Syracuse, United States, 13057

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Fresh Meadows, United States, 11365

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Loveland, United States, 80538

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Duarte, United States, 91010

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Springfield, United States, 1107

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Buffalo, United States, 14263

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Dallas, United States, 75246

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Philadelphia, United States, 19106

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Sioux Falls, United States, 57104

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Kokomo, United States, 46902

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San Francisco, United States, 94115

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Ocoee, United States, 34761

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Lacey, United States, 98503

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Oklahoma City, United States, 73120

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Tulsa, United States, 74136

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Vancouver, United States, 98684

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Panama City, United States, 32405

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Richmond, United States, 23229

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Evansville, United States, 47715

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Louisville, United States, 40207

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Cedar Rapids, United States, 52403

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Hialeah, United States, 33016

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Valparaiso, United States, 46383

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Coeur D Alene, United States, 83814

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Johnson City, United States, 13790

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Morgantown, United States, 26505

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Ames, United States, 50010

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Boston, United States, 02215

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Tacoma, United States, 98405

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St Louis, United States, 63141

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Norfolk, United States, 23502 

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Niles, United States, 60714

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Louisville, United States, 40215

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Austin, United States, 78731

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Glendale, United States, 91206

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Pollocksville, United States, 28573

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Mount Kisco, United States, 10549

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Austin, United States, 78759

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Grand Rapids, United States, 49546

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Lemoyne, United States, 17043

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Fishers, United States, 46038

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Amarillo, United States, 79106

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Southington, United States, 06489

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Lafayette, United States, 70506

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Wichita, United States, 67214

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Harvey, United States, 60426

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Tampa, United States, 33607

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Milwaukee, United States, 53215

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Medford, United States, 97504

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Sioux City, United States, 51101

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Charleston, United States, 29406

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Willmar, United States, 56201

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Atlanta, United States, 30342

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Ft Lauderdale, United States, 33308

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Florence, United States, 29501

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New Britain, United States, 06050

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Fairfax, United States, 22031

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Santa Fe, United States, 87505

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Midland, United States, 79701

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Cincinnati, United States, 45236

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Richmond, United States, 23235

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Phillipsburg, United States, 08865

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Los Angeles, United States, 90057

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Joliet, United States, 60435

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Long Branch, United States, 07740

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Barberton, United States, 44203

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Hickory, United States, 28602

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Mineola, United States, 11501

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Des Moines, United States, 50309

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Jacksonville, United States, 32207

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Denver, United States, 80218

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Long Beach, United States, 90813

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Ann Arbor, United States, 48106

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Melbourne, United States, 32901

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Sacramento, United States, 95823

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Dunkirk, United States, 14048

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Columbia, United States, 29210

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Omaha, United States, 68122

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Highland, United States, 92346

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Bessemer, United States, 35023

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Charlotte, United States, 28203

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Overland Park, United States, 66210

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Louisville, United States, 40202

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Summit, United States, 07901

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Shreveport, United States, 71105

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Memphis, United States, 38104

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Omaha, United States, 68114

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Morristown, United States, 07962

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Belleville, United States, 07109

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Quincy, United States, 02169

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Tyler, United States, 75702

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Philadelphia, United States, 19104

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Glenwood Springs, United States, 81601

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Conway, United States, 72034

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Richmond, United States, 23298

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Kittanning, United States, 16201

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Montclair, United States, 07042

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San Antonio, United States, 78245

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Norwich, United States, 06360

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Bethesda, United States, 20817

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Cleveland, United States, 44195

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Los Angeles, United States, 90095

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Trumbull, United States, 06611

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Cranston, United States, 02920

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North Platte, United States, 69103

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Kansas City, United States, 64118

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Omaha, United States, 68124

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Allentown, United States, 18105

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Yakima, United States, 98902

Trial Design