Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology, Hospital
Therapuetic Areas:Cardiology / Vascular Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:November 2011
End Date:August 2014
Contact:Sandra Beaird, PhD
Email:FRXClinTrials@frx.com
Phone:1-800-678-1605

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Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator


This study will evaluate the efficacy and safety of Azimilide on the incidence of
cardiovascular hospitalizations, cardiovascular emergency department visits or
cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)


Inclusion Criteria:

- Have an ICD implanted and a history of ventricular tachycardia, ventricular
fibrillation, or an appropriate ICD therapy.

- Have a left ventricular ejection fraction <= 0.40

Exclusion Criteria:

- Have New York Heart Association (NYHA) Class IV Congestive Heart Failure (CHF) or
have decompensated CHF at the time of randomization;

- Have unstable angina pectoris or a myocardial infarction within 30 days of
randomization;

- Have a history of Torsade de Pointes or heart transplantation

- Have chronic atrial fibrillation or atrial fibrillation/flutter, that is not
adequately rate controlled in the judgment of the Investigator, at screening;

- Are currently taking systemic Class I or other Class III antiarrhythmic drugs

- Are currently taking systemic drugs that prolong the QT interval

- If female, are currently pregnant or breast feeding, or plan to become pregnant
during the course of the study
We found this trial at
117
sites
Beaver, Pennsylvania 15009
2103
mi
from 91732
Beaver, PA
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Albany, New York 12205
2440
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Albany, NY
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Albany, New York 12211
2440
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Albany, NY
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Albuquerque, New Mexico 87102
649
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Albuquerque, NM
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Auburn, Maine 04210
2615
mi
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Auburn, ME
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Augusta, Georgia 30901
2059
mi
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Augusta, GA
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Austin, Texas 78705
1212
mi
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Austin, TX
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Austin, Texas 78756
1211
mi
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Austin, TX
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Baltimore, Maryland 21237
2301
mi
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Baltimore, MD
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Baltimore, Maryland 21201
2301
mi
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Baltimore, MD
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Baton Rouge, Louisiana 70808
1582
mi
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Baton Rouge, LA
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Birmingham, Alabama 35211
1784
mi
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Birmingham, AL
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Bloomington, Indiana 47402
1771
mi
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Bloomington, IN
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Boise, Idaho 83712
665
mi
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Boise, ID
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Boston, Massachusetts 02115
2578
mi
from 91732
Boston, MA
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Boston, Massachusetts 02215
2578
mi
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Boston, MA
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Bridgeport, Connecticut 06610
2473
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Bridgeport, CT
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Brighton, Massachusetts 02135
2573
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Brighton, MA
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Brooklyn, New York 11215
2436
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Brooklyn, NY
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Brooklyn, New York 11212
2436
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Brooklyn, NY
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Camp Hill, Pennsylvania 17011
2281
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Camp Hill, PA
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Canton, Ohio 44708
2047
mi
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Canton, OH
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Charleston, South Carolina 29425
2184
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Charleston, SC
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Charleston, South Carolina 29407
2180
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Charleston, SC
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Chesapeake, Virginia 23320
2340
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Chesapeake, VA
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Chicago, Illinois 60611
1730
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Chicago, IL
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Chicago, Illinois 60640
1728
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Chicago, IL
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Cincinnati, Ohio 45219
1879
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Cincinnati, OH
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Cincinnati, Ohio 45242
1880
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Cincinnati, OH
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Colorado Springs, Colorado 80909
805
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Colorado Springs, CO
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Colorado Springs, Colorado 80907
802
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Colorado Springs, CO
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Columbia, South Carolina 29204
2104
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Columbia, SC
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Columbus, Ohio 43214
1960
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Columbus, OH
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Crestview Hills, Kentucky 41017
1876
mi
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Crestview Hills, KY
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Dallas, Texas 75390
1224
mi
from 91732
Dallas, TX
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Dallas, Texas 75231
1226
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from 91732
Dallas, TX
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Dayton, Ohio 45417
1894
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Dayton, OH
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Englewood,, New Jersey 07631
2433
mi
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Englewood,, NJ
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Erie, Pennsylvania 16507
2117
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Erie, PA
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Erie, Pennsylvania 16502
2117
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Erie, PA
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Fairfield, Ohio 45014
1877
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Fairfield, OH
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Falls Church, Virginia 22042
2273
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Falls Church, VA
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Flint, Michigan 48532
1934
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Flint, MI
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Fort Lauderdale, Florida 33306
2315
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Fort Lauderdale, FL
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Fort Worth, Texas 76104
1194
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Fort Worth, TX
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Ft. Lauderdale, Florida 33308
2315
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Ft. Lauderdale, FL
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Glendale, California 91206
14
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Glendale, CA
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Green Bay, Wisconsin 54301
1746
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Green Bay, WI
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Greensboro, North Carolina 27401
2151
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Greensboro, NC
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Greenville, South Carolina 29607
2018
mi
from 91732
Greenville, SC
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Hershey, Pennsylvania 17033
2295
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Hershey, PA
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Hickory, North Carolina 28601
2069
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Hickory, NC
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Hollywood, Florida 33021
2317
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Hollywood, FL
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Houma, Louisiana 70360
1626
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Houma, LA
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Houston, Texas 77074
1351
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Houston, TX
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Houston, Texas 77094
1357
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Houston, TX
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Huntsville, Alabama 35801
1784
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Huntsville, AL
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Indianapolis, Indiana 46237
1793
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Indianapolis, IN
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Jacksonville, Florida 32204
2130
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Jacksonville, Florida 32224
2130
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Jerseyville, Illinois 62052
1568
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Kettering, Ohio 45429
1898
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Kettering, OH
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Kissimmee, Florida 34741
2187
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Kissimmee, FL
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La Jolla, California 92093
95
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Lanham, Maryland 20706
2290
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Lanham, MD
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Lansing, Michigan 48910
1891
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Lansing, MI
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Lincoln, Nebraska 68506
1254
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Lincoln, NE
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Littleton, Colorado 80712
813
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Los Angeles, California 99048
13
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Louiseville, Kentucky 40202
1812
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Lynchburg, Virginia 24501
2176
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Madison, Wisconsin 53715
1656
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Milwaukee, Wisconsin 53215
1729
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Minneapolis, Minnesota 55455
1510
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Minneapolis, MN
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New York, New York 10032
2432
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New York, NY
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New York, New York 10021
2432
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New York, NY
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New York, New York 10023
2432
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Newark, Delaware 19718
2345
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Newark, DE
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Newport News, Virginia 23601
2324
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Newport News, VA
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Norfolk, Virginia 23510
2337
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Norfolk, VA
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North Miami, Florida 33161
2319
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North Miami Beach, Florida 33179
2319
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Oklahoma City, Oklahoma 73120
1164
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Omaha, Nebraska 68114
1300
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Overland Park, Kansas 66209
1335
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Philadelphia, Pennsylvania 19102
2375
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Philadelphia, PA
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Philadelphia, Pennsylvania 19141
2375
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Philadelphia, PA
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Phoenix, Arizona 85013
343
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Phoenix, AZ
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Port Charlotte, Florida 33952
2180
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Port Charlotte, FL
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Providence, Rhode Island 02903
2562
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Providence, RI
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Rapid City, South Dakota 57701
1049
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Rapid City, SD
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Richmond, Virginia 23219
2268
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Richmond, VA
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Ridgewood, New Jersey 07450
2426
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Ridgewood, NJ
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Roanoke, Virginia 24104
2133
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Roanoke, VA
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Rockledge, Florida 32955
2225
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Rockledge, FL
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Saginaw, Michigan 48601
1927
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Saginaw, MI
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San Diego, California 92123
101
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San Diego, CA
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San Diego, California 92103
103
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San Diego, CA
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Silver Spring, Maryland 20903
2281
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Silver Spring, MD
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Sioux Falls, South Dakota 57108
1313
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Sioux Falls, SD
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South Bend, Indiana 46601
1798
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South Bend, IN
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