Study Stopped
Insufficient efficacy observed in study BCDM (NCT01198002) and BCDV (NCT01202773).
An Open Label Study for Participants With Rheumatoid Arthritis
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)
2 other identifiers
interventional
1,086
27 countries
327
Brief Summary
The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in participants with Rheumatoid Arthritis. This study is comprised of 2 periods: Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002). Period 2: 48-week post-treatment follow-up
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Jun 2011
Typical duration for phase_3 rheumatoid-arthritis
327 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
October 5, 2010
CompletedFirst Posted
Study publicly available on registry
October 7, 2010
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
June 11, 2018
CompletedJune 11, 2018
May 1, 2018
2.7 years
October 5, 2010
March 24, 2018
May 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
A TEAE was defined as an event that first occurred or worsened in severity on or after the date of the first injection and prior to study termination. AESI are infection, injection site reactions, malignancy, major adverse cardiovascular events (MACE), allergy and hypersensitivity, depression, suicide/self-injury and pregnancy. MACE were defined as 1 of the adjudicated events: cardiovascular death, Myocardial infarction (MI), stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure, peripheral revascularization procedure, cardiogenic shock due to MI, resuscitated sudden death, serious arrhythmia, hospitalization for hypertension, peripheral arterial event. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
up to 84.4 weeks during treatment period
Percentage of Participants Developing Anti-LY2127399 Antibodies
Participants with treatment-emergent anti-LY2127399 antibodies were participants who had any samples from baseline up to and through Week 72 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants with anti-LY2127399 antibodies=(number of participants with treatment-emergent anti-LY2127399 antibodies / number of participants assessed)\*100.
Baseline through Weeks 4, 24, 48 and 72
Change From Baseline in Absolute B Cell Counts
Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment in preceding studies, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively, in B cell count.
Baseline, Week 48
Change From Baseline in Serum Immunoglobulin (Ig) Levels
Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP.
Baseline, Week 48
Secondary Outcomes (12)
Percentage of Participants With American College of Rheumatology 20% Response (ACR20)
Baseline through Weeks 12, 24 and 48
Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)
Baseline, 240 weeks
Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR-28) Response
Baseline through 240 weeks
Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores
Baseline, 240 weeks
Change From Baseline in Tender Joint Count (68 Joint Count)
Baseline, 240 weeks
- +7 more secondary outcomes
Other Outcomes (1)
Number of Participants Who Died During Treatment Period and Post-Treatment Follow-Up Period
Up to 84.4 weeks during treatment period and discontinuation from study treatment up to 48 weeks during follow-up period
Study Arms (2)
120 milligrams (mg) of LY2127399
EXPERIMENTALGiven every 4 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 240 mg loading dose when initiating treatment. Or Given every 4 weeks for 168 weeks for those participants from Study BCDM.
90 mg LY2127399
EXPERIMENTALGiven every 2 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 180 mg loading dose when initiating treatment. Or Given every 2 weeks for 168 weeks for those participants from Study BCDM.
Interventions
Administered Subcutaneously
Eligibility Criteria
You may qualify if:
- Have completed 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM
- Woman must not be pregnant, breastfeeding, or become pregnant during the study
You may not qualify if:
- Current presence of a serious disorder or illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (327)
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Birmingham, Alabama, 35216, United States
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Huntsville, Alabama, 35810, United States
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Peoria, Arizona, 85381, United States
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Phoenix, Arizona, 85032, United States
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Scottsdale, Arizona, 85251, United States
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Tucson, Arizona, 85704, United States
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Hot Springs, Arkansas, 71913, United States
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Jonesboro, Arkansas, 72401, United States
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Little Rock, Arkansas, 72205, United States
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Escondido, California, 92027, United States
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Fresno, California, 93720, United States
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Hemet, California, 92543, United States
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Huntington Beach, California, 92646, United States
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La Jolla, California, 92037, United States
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La Mesa, California, 91942, United States
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Loma Linda, California, 92354, United States
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Long Beach, California, 90808, United States
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Los Angeles, California, 90022, United States
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Sacramento, California, 95825, United States
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San Diego, California, 92108, United States
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Santa Monica, California, 90404, United States
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Torrance, California, 90505, United States
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Tustin, California, 92780, United States
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Upland, California, 91786, United States
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Wildomar, California, 92595, United States
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Colorado Springs, Colorado, 80910, United States
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Denver, Colorado, 80209, United States
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Lewes, Delaware, 19958, United States
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Aventura, Florida, 33180, United States
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Boca Raton, Florida, 33486, United States
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Boynton Beach, Florida, 33472, United States
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DeBary, Florida, 32713, United States
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Miami, Florida, 33173, United States
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New Port Richey, Florida, 34652, United States
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Palm Harbor, Florida, 34684, United States
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Pinellas Park, Florida, 33781, United States
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St. Petersburg, Florida, 33716, United States
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Tamarac, Florida, 33321, United States
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Tampa, Florida, 33609, United States
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Venice, Florida, 34292, United States
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Vero Beach, Florida, 32960, United States
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West Palm Beach, Florida, 33401, United States
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Zephyrhills, Florida, 33542, United States
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Atlanta, Georgia, 30342, United States
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Decatur, Georgia, 30033, United States
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Dunwoody, Georgia, 30338, United States
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Gainesville, Georgia, 30501, United States
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Lawrenceville, Georgia, 30045, United States
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Marietta, Georgia, 30060, United States
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Savannah, Georgia, 31405, United States
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Stockbridge, Georgia, 30281, United States
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Eagle, Idaho, 83616, United States
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Idaho Falls, Idaho, 83404, United States
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Morton Grove, Illinois, 60053, United States
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Peoria, Illinois, 61636, United States
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Rockford, Illinois, 61103, United States
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Brownsburg, Indiana, 46112, United States
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Evansville, Indiana, 47714, United States
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Indianapolis, Indiana, 46227, United States
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Kansas City, Kansas, 66160, United States
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Shawnee Mission, Kansas, 66218, United States
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Wichita, Kansas, 67208, United States
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Bowling Green, Kentucky, 42101, United States
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Owensboro, Kentucky, 42303, United States
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Monroe, Louisiana, 71203, United States
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Cumberland, Maryland, 21502, United States
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Wheaton, Maryland, 20902, United States
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Haverhill, Massachusetts, 01830, United States
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Worcester, Massachusetts, 01605, United States
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Bingham Farms, Michigan, 48025, United States
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Saint Clair Shores, Michigan, 48081, United States
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Flowood, Mississippi, 39232, United States
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Jackson, Mississippi, 39202, United States
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Florissant, Missouri, 63031, United States
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St Louis, Missouri, 63131, United States
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Kalispell, Montana, 59901, United States
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Lincoln, Nebraska, 68516, United States
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Omaha, Nebraska, 68134, United States
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Las Vegas, Nevada, 89128, United States
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Nashua, New Hampshire, 03060, United States
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Berkeley Heights, New Jersey, 07922, United States
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Clifton, New Jersey, 07012, United States
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Albuquerque, New Mexico, 87108, United States
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Brooklyn, New York, 11201, United States
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Roslyn, New York, 11576, United States
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Syracuse, New York, 13210, United States
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Charlotte, North Carolina, 28210, United States
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Hickory, North Carolina, 28601, United States
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Raleigh, North Carolina, 27609, United States
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Sanford, North Carolina, 27330, United States
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Bismarck, North Dakota, 58502, 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, 74135, United States
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Bend, Oregon, 97701, United States
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Bethlehem, Pennsylvania, 18017, United States
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Erie, Pennsylvania, 16508, United States
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Limerick, Pennsylvania, 19468, United States
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Philadelphia, Pennsylvania, 19152, United States
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Pottstown, Pennsylvania, 19464, United States
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Columbia, South Carolina, 29204, United States
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Greenville, South Carolina, 29601, United States
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Greer, South Carolina, 29650, United States
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Myrtle Beach, South Carolina, 29572, United States
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North Charleston, South Carolina, 29406, United States
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Taylors, South Carolina, 29687, United States
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Knoxville, Tennessee, 37909, United States
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Memphis, Tennessee, 38119, United States
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Nashville, Tennessee, 37205, United States
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Austin, Texas, 78731, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77090, United States
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Lake Jackson, Texas, 77566, United States
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Lubbock, Texas, 79424, United States
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Mesquite, Texas, 75150, United States
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Nassau Bay, Texas, 77058, United States
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North Richland Hills, Texas, 76180, United States
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San Antonio, Texas, 78217, United States
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Sugar Land, Texas, 77478, United States
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Burlington, Vermont, 05401, United States
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Richmond, Virginia, 23225, United States
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Spokane, Washington, 99204, United States
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Tacoma, Washington, 98405, United States
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Wenatchee, Washington, 98801, United States
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Clarksburg, West Virginia, 26301, United States
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Milwaukee, Wisconsin, 53226, United States
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Racine, Wisconsin, 53406, United States
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Buenos Aires, C1280AEB, Argentina
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Córdoba, X5016KEH, Argentina
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Luján, 6700, Argentina
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Mar del Plata, B7600FZN, Argentina
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Quilmes, B1878DVC, Argentina
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Rosario, 2000, Argentina
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San Juan, 5400, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Campbelltown, New South Wales, 2560, Australia
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Kogarah, New South Wales, 04266-010, Australia
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Herston, Queensland, 4029, Australia
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Malvern East, 3145, Australia
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Campinas, 13059-000, Brazil
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Caxias do Sul, 95070-560, Brazil
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Curitiba, 80060-240, Brazil
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Fortaleza, 60150-170, Brazil
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Juiz de Fora, 36010-570, Brazil
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Rio de Janeiro, 20551-030, Brazil
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São Paulo, 05403-000, Brazil
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Setor Oeste/Goiania, 74110-129, Brazil
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Burgas, 8000, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4003, Bulgaria
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Rousse, 7002, Bulgaria
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Sevlievo, 5400, Bulgaria
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Sofia, 1784, Bulgaria
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Varna, 9000, Bulgaria
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Bogotá, Colombia
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Medellín, Colombia
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Opatija, 51410, Croatia
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Osijek, 31000, Croatia
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Rijeka, HR-51000, Croatia
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Montpellier, 34295, France
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Nice, 06202, France
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Orléans, 45000, France
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Paris, 75022, France
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Saint-Etienne, 42055, France
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Strasbourg, 67 098, France
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Toulouse, 31059, France
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Bad Doberan, 18209, Germany
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Bad Nauheim, 61231, Germany
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Baden-Baden, 76530, Germany
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Berlin, 14059, Germany
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Cologne, 50924, Germany
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Dresden, 01307, Germany
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Erlangen, 91054, Germany
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Frankfurt, 60590, Germany
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Göttingen, 37075, Germany
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Munich, 80639, Germany
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Haidari/Athens, 12462, Greece
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Heraklion, 71110, Greece
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Larissa, 411 10, Greece
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Thessaloniki, 54636, Greece
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Baja, 6500, Hungary
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Balassagyarmat, 2660, Hungary
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Budapest, 1062, Hungary
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Debrecen, 4032, Hungary
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Esztergom, 2500, Hungary
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Kiskunhalas, 6400, Hungary
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Nyíregyháza, 4400, Hungary
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Sátoraljaújhely, 3980, Hungary
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Szikszó, 3800, Hungary
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Veszprém, 8200, Hungary
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Ahmedabad, 3800015, India
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Bangalore, 5600092, India
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Chennai, 600100, India
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Hyderabaad, 500082, India
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Jaipur, 302023, India
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Lucknow, 226 014, India
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Mysore, 570023, India
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Nellore, 524003, India
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New Delhi, 110 076, India
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Secunderabad, 500 003, India
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Surat, 395003, India
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Aichi, 460-0001, Japan
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Chiba, 260-8712, Japan
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Fukuoka, 807-8555, Japan
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Gunma, 370-0053, Japan
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Hokkaido, 063-0811, Japan
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Hyōgo, 650-0017, Japan
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Ibaraki, 305-8576, Japan
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Ibaraki, 316-0035, Japan
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Japan, 275-0006, Japan
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Kagoshima, 891-0133, Japan
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Kanagawa, 252-0392, Japan
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Kumamoto, 861-8520, Japan
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Mie, 514-1101, Japan
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Miyagi, 982-0032, Japan
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Miyazaki, 880-0122, Japan
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Nagano, 380-8582, Japan
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Nagasaki, 857-1195, Japan
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Nara, 634-0007, Japan
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Ohita, 874-0011, Japan
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Okayama, 710-0016, Japan
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Osaka, 586-8521, Japan
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Saga, 843-0393, Japan
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Saitama, 337-0012, Japan
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Sapporo, 060-8648, Japan
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Shizuoka, 420-8623, Japan
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Tokushima, 770-8503, Japan
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Tokyo, 113-0034, Japan
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Toyama, 933-0874, Japan
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Alytus, 62114, Lithuania
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Kaunas, 49475, Lithuania
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Klaipedos, 92288, Lithuania
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Šiauliai, 73231, Lithuania
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Vilnius, LT-08661, Lithuania
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Batu Caves, 68100, Malaysia
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Kota Bharu, 15586, Malaysia
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Kuantan Pahang, 25100, Malaysia
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Perak, 30990, Malaysia
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Putrajaya, 62250, Malaysia
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Sarawak, 93586, Malaysia
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Aguascalientes, 20000, Mexico
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Barrio San Mateo, 52140, Mexico
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Chihuahua City, 31000, Mexico
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Guadalajara, 44690, Mexico
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Mexicali, 21100, Mexico
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Mexico City, 03720, Mexico
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Monterrey, 64460, Mexico
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Morelia, 58070, Mexico
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Querétaro, 76000, Mexico
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San Luis Potosí City, 78200, Mexico
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Tijuana, 22010, Mexico
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Hamilton, 3204, New Zealand
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Rotorua, 3010, New Zealand
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Tauranga, 3140, New Zealand
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Timaru, New Zealand
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Bydgoszcz, 85-168, Poland
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Działdowo, 13-200, Poland
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Elblag, 82-300, Poland
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Gdynia, 81-384, Poland
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Krakow, 30-510, Poland
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Lublin, 20-607, Poland
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Płock, 09-400, Poland
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Torun, 87-100, Poland
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Warsaw, 01-192, Poland
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Włoszczowa, 29-100, Poland
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Brasov, 500365, Romania
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Cluj-Napoca, 400130, Romania
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Iași, 700656, Romania
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Ploieşti, 100337, Romania
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Barnaul, 656038, Russia
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Kazan', 420029, Russia
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Kemerovo, 650066, Russia
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Khanty-Mansiysk, 628012, Russia
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Kursk, 305007, Russia
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Moscow, 125299, Russia
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Nizhny Novgorod, 603005, Russia
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Novosibirsk, 630047, Russia
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Petrozavodsk, 185019, Russia
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Ryazan, 390026, Russia
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Saint Petersburg, 197022, Russia
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Saratov, 410002, Russia
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Stavropol, 355017, Russia
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Voronezh, 394066, Russia
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Bratislava, 84231, Slovakia
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Dunajská Streda, 929 01, Slovakia
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Piešťany, 921 12, Slovakia
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Benoni, 1500, South Africa
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Bloemfontein, 9301, South Africa
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Breyten, 2330, South Africa
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Cape Town, 7925, South Africa
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Durban, 4092, South Africa
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Limpopo, 0380, South Africa
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Pretoria, 0184, South Africa
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Somerset West, 7130, South Africa
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Stellenbosch, 7600, South Africa
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Busan, 602-715, South Korea
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Daegu, 700-721, South Korea
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Daejeon, 301-721, South Korea
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Incheon, 400-711, South Korea
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Seongnam-si, 463-707, South Korea
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Seoul, 143-729, South Korea
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Suwon, 442-721, South Korea
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A Coruña, 15006, Spain
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Barcelona, 08034, Spain
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Bilboa, 48013, Spain
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Donostia / San Sebastian, 20014, Spain
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Madrid, 28046, Spain
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Colombo, Sri Lanka
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Galle, Sri Lanka
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Kalubowila, Sri Lanka
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Nugegoda, Sri Lanka
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Keelung, 204, Taiwan
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Kuei Shan Hsiang, 33305, Taiwan
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Niao Sung Hsiang, 833, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 112, Taiwan
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Dnipropetrovsk, 49008, Ukraine
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Donetsk, 83114, Ukraine
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Kharkiv, 61178, Ukraine
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Kiev, 04114, Ukraine
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Kyiv, 03151, Ukraine
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Odesa, 65026, Ukraine
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Poltava, 36038, Ukraine
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Simferopol, 95017, Ukraine
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Vinnitsa, 21000, Ukraine
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Vinnytsia, 21018, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study BCDP was terminated early due to insufficient efficacy observed in Studies BCDM and BCDV. 4 participants enrolled from Study BCDM were included in TEAE, SAE, AESI and death summary but not in summary of other primary or secondary measures.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UCT/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2010
First Posted
October 7, 2010
Study Start
June 1, 2011
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
June 11, 2018
Results First Posted
June 11, 2018
Record last verified: 2018-05