BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose

Last updated: April 3, 2015
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Scar Tissue

Neurologic Disorders

Memory Loss

Treatment

N/A

Clinical Study ID

NCT00459667
91656
2006-005270-47
309363
  • Ages 18-55
  • All Genders

Study Summary

The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completion of the BEYOND study 306440 as scheduled

  • Relapsing multiple sclerosis

  • Medical assessment by the investigator that there is no objection to the patient'sparticipation in this trial considering the medical experience from study 306440.Special attention should be given to laboratory abnormalities and clinically relevantliver, renal and bone-marrow dysfunction.

  • Females of child-bearing potential:

  • Agreement to practice adequate contraception methods and

  • Negative pregnancy test and

  • No lactation

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Serious or acute heart diseases

  • History of severe depression or suicide attempt

  • Epilepsy not adequately controlled by treatment

  • Known allergy to IFNs, to human albumin or to mannitol

  • Medical, psychiatric or other conditions that compromise the patient's ability tounderstand the patient information, to give informed consent, to comply with the trialprotocol, or to complete the study

Study Design

Total Participants: 1420
Study Start date:
May 01, 2007
Estimated Completion Date:
March 31, 2008

Study Description

Phase A (3 arm parallel group): All patients randomized during the BEYOND study (Bayer 306440) to either IFNB 1b group (250µg or 500µg) will continue their previously assigned study medication, applying the same level of blinding as during the BEYOND study, All patients randomized during the BEYOND study to Copaxone and all patients with premature discontinuation of study medication during the BEYOND study will receive open-label IFNB 1b 250µg.

Phase B (single arm): All patients will receive open-label IFNB 1b 500µg)

Randomization: No randomization in this trial, patient's allocation in this follow-up study depends only on prior trial groups. The preceding study was randomized.

The trial is sponsored by Bayer Schering Pharma AG, Germany, Bayer HealthCare and Bayer HealthCare Pharmaceuticals Inc.

Secondary outcome measure "Assessment of patient-reported outcomes (FAMS and EQ 5D: The variables FAMS and EQ-5D were not analyzed due to the termination of the study before start of Phase B.

Connect with a study center

  • Buenos Aires, Ciudad Auton. de Buenos Aires C1117ABE
    Argentina

    Site Not Available

  • Cordoba, Córdoba X5000HGX
    Argentina

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  • Rosario, Santa Fe S2000ZBL
    Argentina

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  • Kogarah, New South Wales 2217
    Australia

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  • Fitzroy, Victoria 3065
    Australia

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  • Parkville, Victoria 3050
    Australia

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  • Nedlands, Western Australia 6009
    Australia

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  • Liverpool, NSW 2170
    Australia

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  • Wyoming, NSW 2250
    Australia

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  • St Poelten, Niederösterreich A-3100
    Austria

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  • Graz, 8036
    Austria

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  • Innsbruck, 6020
    Austria

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  • Linz, 4020
    Austria

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  • Brussel, 1090
    Belgium

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  • Leuven, 3000
    Belgium

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  • Melsbroek, 1820
    Belgium

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  • Curitiba, Parana 80240-340
    Brazil

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  • Recife, Pernambuco 52010-040
    Brazil

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  • Porto Alegre, Rio Grande do Sul 90035-001
    Brazil

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  • Campinas, Sao Paulo 13081- 970
    Brazil

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  • Rio de Janeiro, 21941-590
    Brazil

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  • Sao Paulo, 04039-032
    Brazil

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  • Calgary, Alberta T2N 2T9
    Canada

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  • Vancouver, British Columbia V6T 2B5
    Canada

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  • Halifax, Nova Scotia B3H 2Y9
    Canada

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  • London, Ontario N6A 5A5
    Canada

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  • Mississauga, Ontario L5B 1B8
    Canada

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  • Nepean, Ontario K2G 6E2
    Canada

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  • Ottawa, Ontario K1H 8L6
    Canada

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  • Toronto, Ontario M5B 1W8
    Canada

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  • Greenfield Park, Quebec J4V 2H1
    Canada

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  • Hull, Quebec J8Y 1W7
    Canada

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  • Montreal, Quebec H2L 4M1
    Canada

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  • Aarhus, 8000
    Denmark

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  • Oulu, 90029
    Finland

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  • Tampere, 33521
    Finland

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  • Rennes, Bretagne 35038
    France

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  • Bordeaux, Gironde 33076
    France

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  • Clermont ferrand, 63003
    France

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  • Dijon, 21033
    France

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  • Lille, 59037
    France

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  • Nancy, 54035
    France

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  • Nantes, 44093
    France

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  • Nice, 06000
    France

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  • Nimes, 30029
    France

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  • Toulouse, 31059
    France

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  • Heidelberg, Baden-Württemberg 69120
    Germany

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  • Bayreuth, Bayern 95445
    Germany

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  • Regensburg, Bayern 93053
    Germany

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  • Hennigsdorf, Brandenburg 16761
    Germany

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    Gießen, Hessen 35392
    Germany

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  • Gießen, Hessen 35392
    Germany

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  • Marburg, Hessen 35039
    Germany

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  • Offenbach, Hessen 63069
    Germany

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  • Greifswald, Mecklenburg-Vorpommern 17475
    Germany

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    Göttingen, Niedersachsen 37099
    Germany

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  • Göttingen, Niedersachsen 37099
    Germany

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  • Hannover, Niedersachsen 30625
    Germany

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    Düsseldorf, Nordrhein-Westfalen 40225
    Germany

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    Germany

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  • Essen, Nordrhein-Westfalen 45117
    Germany

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    Münster, Nordrhein-Westfalen 48149
    Germany

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  • Münster, Nordrhein-Westfalen 48149
    Germany

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  • Dresden, Sachsen 01307
    Germany

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  • Leipzig, Sachsen 04129
    Germany

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  • Halle, Sachsen-Anhalt 06120
    Germany

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  • Berlin, 13347
    Germany

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  • Hamburg, 20246
    Germany

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  • Athens, Attica 11527
    Greece

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  • Thessaloniki, 54636
    Greece

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  • Budapest, 1076
    Hungary

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    Györ, 9024
    Hungary

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  • Györ, 9024
    Hungary

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  • Miskolc, 3501
    Hungary

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  • Pecs, 7623
    Hungary

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  • Zalaegerszeg-Pozva, H-8900
    Hungary

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  • Cork,
    Ireland

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  • Dublin, 4
    Ireland

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  • Ashkelon, 78278
    Israel

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  • Haifa, 31048
    Israel

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  • Jerusalem, 91120
    Israel

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  • Tel Hashomer, 52621
    Israel

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  • Tel-Aviv, 64239
    Israel

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  • Zerifin, 70300
    Israel

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  • Orbassano, Torino 10043
    Italy

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  • Bari, 70122
    Italy

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  • Firenze, 50134
    Italy

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  • Milano, 20132
    Italy

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  • Padova, 35128
    Italy

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  • Roma, 00189
    Italy

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  • Riga, LV-1015
    Latvia

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  • Breda, 4819 EV
    Netherlands

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  • Nijmegen, 6533 PA
    Netherlands

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  • Sittard, 6131 BK
    Netherlands

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  • Bergen, N-5021
    Norway

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  • Gdansk, 80-803
    Poland

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  • Katowice, 40752
    Poland

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  • Lodz, 90153
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  • Poznan, 61848
    Poland

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  • Warszawa, 02097
    Poland

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  • Wroclaw, 50420
    Poland

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  • Moskva, 123367
    Russian Federation

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  • Nizhy Novgorod, 603076
    Russian Federation

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  • Novosibirsk, 630007
    Russian Federation

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  • Sankt-Peterburg, 197022
    Russian Federation

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  • St. Petersburg, 197376
    Russian Federation

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  • Yaroslavl, 150039
    Russian Federation

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  • Ljubljana, SI-1525
    Slovenia

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  • Maribor, 2000
    Slovenia

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  • L'Hospitalet de Llobregat, Barcelona 08907
    Spain

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  • Malaga, 29010
    Spain

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  • Sevilla, 41071
    Spain

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  • Stockholm, 182 88
    Sweden

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  • Uppsala, 751 85
    Sweden

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  • Bern, 3010
    Switzerland

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  • St. Gallen, 9007
    Switzerland

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  • Donetsk, 83003
    Ukraine

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  • Kharkiv, 61068
    Ukraine

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  • Kiev, 03110
    Ukraine

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  • Lviv, 79000
    Ukraine

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  • Birmingham, Alabama 35294-7340
    United States

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  • Cullman, Alabama 35058
    United States

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  • Phoenix, Arizona 85013
    United States

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  • Tucson, Arizona 85741
    United States

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  • Berkeley, California 94705
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  • La Jolla, California 92037
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  • Sacramento, California 95817
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  • San Francisco, California 94117
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  • Fort Collins, Colorado 80528
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  • Newark, Delaware 19713
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  • Washington, District of Columbia 20037
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  • Maitland, Florida 32751
    United States

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  • Miami, Florida 33136
    United States

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  • Tampa, Florida 33609
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  • Atlanta, Georgia 30309-1465
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  • Augusta, Georgia 30912
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  • Chicago, Illinois 60637
    United States

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  • Fort Wayne, Indiana 46805
    United States

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  • Indianapolis, Indiana 46202
    United States

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  • Des Moines, Iowa 50314
    United States

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  • Kansas City, Kansas 66160
    United States

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  • Louisville, Kentucky 40202
    United States

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  • Shreveport, Louisiana 71130
    United States

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  • Detroit, Michigan 48202
    United States

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  • Duluth, Minnesota 55805
    United States

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  • St. Louis, Missouri 63110
    United States

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  • Henderson, Nevada 89052
    United States

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  • Reno, Nevada 89509
    United States

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  • Albuquerque, New Mexico 87131-5281
    United States

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  • Mineola, New York 11501
    United States

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  • Rochester, New York 14642
    United States

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  • Stony Brook, New York 11794
    United States

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  • Charlotte, North Carolina 28207
    United States

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  • Durham, North Carolina 27710
    United States

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  • Winston-Salem, North Carolina 27157
    United States

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  • Cincinnati, Ohio 45219
    United States

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  • Columbus, Ohio 43210
    United States

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  • Tualatin, Oregon 97062
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  • Philadelphia, Pennsylvania 19104
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  • Pittsburgh, Pennsylvania 15213
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  • Providence, Rhode Island 02905
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  • Charleston, South Carolina 29425
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  • Nashville, Tennessee 37205
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  • Houston, Texas 77030
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  • San Antonio, Texas 78229
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  • Fairfax, Virginia 22031
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  • Seattle, Washington 98101
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  • Tacoma, Washington 98405
    United States

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  • Milwaukee, Wisconsin 53215
    United States

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