Open-label Trial of Leukine in Active Crohn's Disease | NCT00206700 | Trialant

Open-label Trial of Leukine in Active Crohn's Disease | NCT00206700 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Able to provide informed consent

Participated in a previous study of sargramostim in Crohn's disease within the past 12 months

Subjects who participated in protocols excluding concomitant steroid use:

Must have moderately to severely active Crohn's disease at time of screening (CDAI score >/= 220 points and less than or equal to 475 points)

Must be receiving less than or equal to 40 mg prednisone (or equivalent) daily at time of screening if treated with corticosteroids between completing their previous sargramostim study and entry into this study and be able to taper to less than or equal to 7.5 mg daily within one treatment cycle

Subjects who participated in Protocol 307501

Must have active Crohn's disease (CDAI score > 150 points and less than or equal to 450 points) if completely withdrawn from CS use

Must be receiving less than or equal to 40 mg prednisone (or equivalent) daily at time of screening, be able to taper to less than or equal to 7.5 mg daily within 2 treatment cycles, and have a CDAI score less than or equal to 450 points if not completely withdrawn from CS use

Have a negative serum pregnancy test within 2 weeks prior to receiving initial dose of sargramostim in female subjects of child-bearing potential (optional - may be waived by the investigator if the subject has had no interruption in contraception method since participation in the previous study)

Agree to use of an adequate method of contraception throughout the study period for sexually-active males and females of childbearing potential

Able to self-inject sargramostim or have a designee who can do so

Able to comply with protocol requirements

Have a negative stool exam if subject received a course of antibiotics since participation in the previous study

Exclusion Criteria:

Pregnant or breastfeeding female

Need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage

Gastrointestinal surgery within the prior 6 months

Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected

Serum creatinine greater than or equal to 2.0 mg/dL

Alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin greater or equal to 2X the upper limit of normal; hemoglobin (Hb) < 8.0 gm/dL; platelet count greater than or equal to 800,000/mL; ANC less than or equal to 1,000/µL or > 20,000/µL (the exclusion of subjects with ANC > 20,000/µL applies only to entry into the first treatment cycle)

Use of licensed/registered anti-tumor necrosis factor (TNF) therapy such as infliximab within 8 weeks prior to first dose of study drug in this trial

Use of any of the following medications within 4 weeks prior to receiving the first dose of study drug: 6-mercaptopurine, azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, or thalidomide

Use of any experimental agent in a clinical trial since participating in a sargramostim trial

History of allergy to yeast products or sargramostim

Psychiatric illness or substance abuse that would interfere with ability to comply with protocol requirements or give informed consent

Clinically important primary disease unrelated to Crohn's disease

Prior exposure to natalizumab (Tysabri)

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Birmingham, Alabama 35209, United States

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Scottsdale, Arizona 85259-5404, United States

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Berkeley, California 94705, United States

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Los Angeles, California 90067, United States

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Orange, California 92868, United States

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San Francisco, California 94115, United States

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San Francisco, California 94117, United States

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Tarzana, California 91345, United States

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Aurora, Colorado 80045, United States

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Englewood, Colorado 80110, United States

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Lakewood, Colorado 80215, United States

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Littleton, Colorado 80120, United States

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Washington D.C., District of Columbia 20010, United States

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Boca Raton, Florida 33486, United States

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Clearwater, Florida 33765, United States

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Gainesville, Florida 32608-1197, United States

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Gainesville, Florida 32610-0254, United States

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Hollywood, Florida 33021, United States

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Jacksonville, Florida 32224, United States

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Jacksonville, Florida 32256, United States

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North Miami Beach, Florida 33162, United States

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Winter Park, Florida 32789, United States

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Atlanta, Georgia 30342, United States

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Chicago, Illinois 60637-1470, United States

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Indianapolis, Indiana 46202, United States

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Indianapolis, Indiana 46237, United States

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Lexington, Kentucky 40536, United States

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Louisville, Kentucky 40202, United States

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Lake Charles, Louisiana 70601, United States

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Metairie, Louisiana 70001, United States

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Slidell, Louisiana 70458, United States

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Annapolis, Maryland 21401, United States

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Hagerstown, Maryland 21740, United States

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Towson, Maryland 21204, United States

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Boston, Massachusetts 02114-2696, United States

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Chesterfield, Michigan 48047, United States

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Troy, Michigan 48098, United States

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Plymouth, Minnesota 55446, United States

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Mexico, Missouri 65265, United States

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St Louis, Missouri 63110, United States

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Billings, Montana 59107, United States

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Lincoln, Nebraska 68503, United States

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Lebanon, New Hampshire 03756-0001, United States

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Berlin, New Jersey 08009, United States

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Great Neck, New York 11021, United States

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Mineola, New York 11501-3987, United States

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New York, New York 10029, United States

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Rochester, New York 14607, United States

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Syracuse, New York 13210, United States

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Asheville, North Carolina 28801, United States

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Chapel Hill, North Carolina 27514, United States

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Charlotte, North Carolina 28207, United States

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Greensboro, North Carolina 27403, United States

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Wilmington, North Carolina 28401, United States

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Winston-Salem, North Carolina 27103, 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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Cincinnati, Ohio 45220, United States

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Cincinnati, Ohio 45242, United States

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Oklahoma City, Oklahoma 73104, United States

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Tulsa, Oklahoma 74104, United States

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Portland, Oregon 97213, United States

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Portland, Oregon 97225, United States

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Portland, Oregon 97239, United States

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Hanover, Pennsylvania 17331, United States

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Lancaster, Pennsylvania 17601-2644, United States

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Philadelphia, Pennsylvania 19104-2699, United States

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Pittsburgh, Pennsylvania 15212, United States

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Pittsburgh, Pennsylvania 15213-2592, United States

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Sayre, Pennsylvania 18840, United States

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Charleston, South Carolina 29425, United States

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Columbia, South Carolina 29203, United States

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Bristol, Tennessee 37620, United States

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Jackson, Tennessee 38305, United States

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Kingsport, Tennessee 37660, United States

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Memphis, Tennessee 38119, United States

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Memphis, Tennessee 38120, United States

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Nashville, Tennessee 37205, United States

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Nashville, Tennessee 37232, United States

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Dallas, Texas 75231, United States

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Irving, Texas 75061, United States

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San Antonio, Texas 78229, United States

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Salt Lake City, Utah 84132, United States

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Charlottesville, Virginia 22908, United States

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Chesapeake, Virginia 23320, United States

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Danville, Virginia 24541, United States

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Norfolk, Virginia 23502, United States

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Richmond, Virginia 23249-0002, United States

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Bellevue, Washington 98004, United States

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Seattle, Washington 98104, United States

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Seattle, Washington 98133, United States

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Seattle, Washington 98195, United States

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Spokane, Washington 99204, United States

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Walla Walla, Washington 99362, United States

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Wenatchee, Washington 98801, United States

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Madison, Wisconsin 53792, United States

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Milwaukee, Wisconsin 53215, United States

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Milwaukee, Wisconsin 53226, United States

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Buenos Aires, Buenos Aires F.D. C1264AAA, Argentina

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Garran, Australian Capital Territory 2605, Australia

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Concord, New South Wales 2139, Australia

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New Lambton Heights, New South Wales 2305, Australia

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Sydney, New South Wales 2050, Australia

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Sydney, New South Wales 2200, Australia

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Brisbane, Queensland 4029, Australia

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Brisbane, Queensland 4101, Australia

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Adelaide, South Australia 5043, Australia

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Launceston, Tasmania 7250, Australia

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Ballarat, Victoria 3350, Australia

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Frankston, Victoria 3199, Australia

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Melbourne, Victoria 3065, Australia

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Melbourne, Victoria 3128, Australia

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Parkville, Victoria 3050, Australia

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Prahran, Victoria 3181, Australia

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Fremantle, Western Australia 6160, Australia

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Penrith, 2751, Australia

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Salvador, Estado de Bahia 40110060, Brazil

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Curitiba, Paraná 80060-900, Brazil

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Rio de Janeiro, Rio de Janeiro 21949 900, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo 05403-900, Brazil

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São Paulo, São Paulo 05651-901, Brazil

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Edmonton, Alberta T5H 4B9, Canada

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Edmonton, Alberta T6G 2B7, Canada

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Kelowna, British Columbia V1Y 2H4, Canada

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Vancouver, British Columbia V5Z 1H2, Canada

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Vancouver, British Columbia V6Z 2K5, Canada

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Winnipeg, Manitoba R3A 1R9, Canada

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Hamilton, Ontario L8N 3Z5, Canada

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London, Ontario N6A 5A5, Canada

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Toronto, Ontario M3N 2V7, Canada

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Toronto, Ontario M5G 1X5, Canada

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Windsor, Ontario N9A 1L9, Canada

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Montreal, Quebec H2W 1T8, Canada

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Montreal, Quebec H3A 1A1, Canada

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Montreal, Quebec H3G 1A4, Canada

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Montreal, Quebec H3T 1E2, Canada

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Québec, Quebec G1S 4L8, Canada

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Milford, Auckland 1309, New Zealand

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Auckland, 1023, New Zealand

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Christchurch, 8011, New Zealand

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Hamilton, 3204, New Zealand

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Lipetsk, Russia 398055, Russia

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Moskva, Russia 105203, Russia

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Samara, Russia 443023, Russia

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Moscow, 123154, Russia

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Moscow, 129110, Russia

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Moskva, 127015, Russia

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Volgograd, 400107, Russia

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Basel, Basel 4031, Switzerland

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Bern, Canton of Bern 3010, Switzerland

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Lausanne, Canton of Vaud 1011, Switzerland

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Donetsk, 83017, Ukraine

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Kharkiv, 61001, Ukraine

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Kiev, 03049, Ukraine

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Lviv, 49044, Ukraine

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Vinnitsa, 26014, Ukraine

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Bristol, Avon BS2 8HW, United Kingdom

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London, Greater London W12 0HS, United Kingdom

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Salford, Greater Manchester M6 8HD, United Kingdom

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Edinburgh, Lothian EH4 2XU, United Kingdom

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Liverpool, Merseyside L7 8XP, United Kingdom

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Harrow, Middlesex HA1 3UJ, United Kingdom

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Cardiff, South Glamorgan CF14 4XW, United Kingdom

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Newcastle upon Tyne, Tyne and Wear NE1 4LP, United Kingdom

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London, WC1E 6AU, United Kingdom

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Sheffield, S10 2JF, United Kingdom