Follow-Up Study for Exubera (FUSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00734591
First received: August 12, 2008
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

In studies of Exubera in persons with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All subjects diagnosed with lung cancer had a history of smoking and the number of lung cancer cases observed fell within the expected range based on population-based data. There is currently not enough information to determine if any of the observed lung cancer cases were related to Exubera use, therefore, the study is being conducted to further investigate whether Exubera use makes the appearance of lung cancer more likely.


Condition Intervention
Diabetes Mellitus
Drug: Exubera
Other: Randomized diabetes therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Rate of Primary Lung Cancer Mortality [ Time Frame: Baseline from original trial up to Year 2 of this study ] [ Designated as safety issue: Yes ]
    Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.


Secondary Outcome Measures:
  • Rate of Primary Lung Cancer Mortality Among Former Smokers [ Time Frame: Baseline from original trial up to Year 2 of this study ] [ Designated as safety issue: Yes ]
    Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.

  • Rate of All-cause Mortality [ Time Frame: Baseline from original trial up to Year 2 of this study ] [ Designated as safety issue: Yes ]
    The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.

  • Rate of Primary Lung Cancer Diagnosis [ Time Frame: Baseline from original trial up to Year 2 of this study ] [ Designated as safety issue: Yes ]
    The rate and rate ratio of lung cancer adjudicated as highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer) or likely (some information may have been missing for definite diagnosis) to be newly diagnosed primary lung cancer that occurred anytime from the start of the original trial to the end of FUSE.


Enrollment: 7439
Study Start Date: August 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Previously treated with Exubera Drug: Exubera
Subjects who had been treated with Exubera in a prior Exubera controlled trial. Following initial use of randomized treatment, physicians and subjects were free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).
Previously treated with comparator
Subjects who had been treated with a comparator (other diabetes treatment such as injected insulin) in a prior Exubera controlled trial.
Other: Randomized diabetes therapy

Subjects who had been treated with a comparator (other diabetes treatment including one or more of: subcutaneous insulin, sulfonylureas, biguanides, or thiazolinediones) in a prior Exubera controlled trial.

Following initial use of randomized treatment, physicians and subjects were free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).


Detailed Description:

Both retrospective and prospective components All subjects who participated in one of the 17 included Exubera clinical trials will be invited to participate in the current study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All subjects who participated in a controlled trial of Exubera active within the last five years (17 protocols total)

Criteria

Inclusion Criteria:

  • Previously participated in an eligible Exubera clinical trial
  • Willing to provide study doctor with at least one alternate contact person

Exclusion Criteria:

  • Participated in an investigational study of an unapproved drug since completing the Exubera trial
  • Ever used an other (non-Exubera) inhaled insulin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734591

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Locations
United States, Alabama
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Bay Minette, Alabama, United States, 36507
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Graysville, Alabama, United States, 35073
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Pell City, Alabama, United States, 35125
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Pell City, Alabama, United States, 35128
United States, Arizona
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Glendale, Arizona, United States, 85306
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Phoenix, Arizona, United States, 85051
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Phoenix, Arizona, United States, 85016
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Phoenix, Arizona, United States, 85006
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Phoenix, Arizona, United States, 85028
United States, Arkansas
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Forrest City, Arkansas, United States, 72335
United States, California
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Berkeley, California, United States, 94705
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Concord, California, United States, 94520
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El Cajon, California, United States, 92019
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Encino, California, United States, 91436
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Fresno, California, United States, 93720
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Fullerton, California, United States, 92835
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Huntington Beach, California, United States, 92648
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Long Beach, California, United States, 90806
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Los Angeles, California, United States, 90073
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Rolling Hills Estates, California, United States, 90274
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San Diego, California, United States, 92128
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San Diego, California, United States, 92120
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San Jose, California, United States, 95116
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Santa Ana, California, United States, 92704
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Santa Barbara, California, United States, 93105
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Tustin, California, United States, 92780
United States, Colorado
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Denver, Colorado, United States, 80209
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Denver, Colorado, United States, 80206
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Denver, Colorado, United States, 80220
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Golden, Colorado, United States, 80401
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Longmont, Colorado, United States, 80501
United States, Connecticut
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Milford, Connecticut, United States, 06460
United States, Delaware
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Newark, Delaware, United States, 19713
United States, District of Columbia
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Washington, District of Columbia, United States, 20010
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Washington, District of Columbia, United States, 20307
United States, Florida
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Boca Raton, Florida, United States, 33433
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Chiefland, Florida, United States, 32626
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Green Cove Springs, Florida, United States, 32043
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Kissimmee, Florida, United States, 34743
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Lake City, Florida, United States, 32025
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Lake Mary, Florida, United States, 32746
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Miami, Florida, United States, 33136
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Opa Locka, Florida, United States, 33054-3818
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St. Cloud, Florida, United States, 34769
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Tampa, Florida, United States, 33624
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West Palm Beach, Florida, United States, 33401
United States, Georgia
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Atlanta, Georgia, United States, 30342
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Atlanta, Georgia, United States, 30318-2513
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Conyers, Georgia, United States, 30013
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Decatur, Georgia, United States, 30035
United States, Hawaii
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Honolulu, Hawaii, United States, 96814
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Honolulu, Hawaii, United States, 96813
United States, Idaho
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Hayden Lake, Idaho, United States, 83835
United States, Illinois
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Greenville, Illinois, United States, 62246
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Normal, Illinois, United States, 61761
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Olympia Fields, Illinois, United States, 60461
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Springfield, Illinois, United States, 62704
United States, Indiana
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Fishers, Indiana, United States, 46038
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Indianapolis, Indiana, United States, 46229
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Indianapolis, Indiana, United States, 46254-5472
United States, Iowa
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Des Moines, Iowa, United States, 50314
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Des Moines, Iowa, United States, 50315
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Dubuque, Iowa, United States, 52002
United States, Kansas
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Wichita, Kansas, United States, 67203
United States, Kentucky
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Louisville, Kentucky, United States, 40213
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Louisville, Kentucky, United States, 40258
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Mount Sterling, Kentucky, United States, 40353
United States, Maryland
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Baltimore, Maryland, United States, 21204
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Elkton, Maryland, United States, 21921
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Glen Burnie, Maryland, United States, 21061
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Wheaton, Maryland, United States, 20902
United States, Massachusetts
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Boston, Massachusetts, United States, 02114
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Springfield, Massachusetts, United States, 01105
United States, Michigan
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Ann Arbor, Michigan, United States, 48104
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Clinton, Michigan, United States, 49236
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Flint, Michigan, United States, 48532
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Muskegon, Michigan, United States, 49444
United States, Minnesota
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Saint Cloud, Minnesota, United States, 56301
United States, Missouri
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Kansas City, Missouri, United States, 64116
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Springfield, Missouri, United States, 65807
United States, Nevada
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Incline Village, Nevada, United States, 89452
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Las Vegas, Nevada, United States, 89128
United States, New Jersey
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Belvidere, New Jersey, United States, 07823
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New Brunswick, New Jersey, United States, 08901
United States, New Mexico
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Albuquerque, New Mexico, United States, 87106
United States, New York
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Albany, New York, United States, 12208
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Babylon, New York, United States, 11702
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Brooklyn, New York, United States, 11224
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Minneola, New York, United States, 11501
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New Hartford, New York, United States, 13413
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Syracuse, New York, United States, 13210
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Williamsville, New York, United States, 14221
United States, North Carolina
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Asheboro, North Carolina, United States, 27203
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Charlotte, North Carolina, United States, 28227
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Durham, North Carolina, United States, 27713
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Morehead City, North Carolina, United States, 28557-3126
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Raleigh, North Carolina, United States, 27609
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Tabor City, North Carolina, United States, 28463
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Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Columbus, Ohio, United States, 43207
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Dayton, Ohio, United States, 45419
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Kettering, Ohio, United States, 45429
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Marietta, Ohio, United States, 45750
United States, Oregon
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Portland, Oregon, United States, 97210
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Portland, Oregon, United States, 97232
United States, Pennsylvania
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Fogelsville, Pennsylvania, United States, 18051
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Hanover, Pennsylvania, United States, 17331
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Harrisburg, Pennsylvania, United States, 17112
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Jeannette, Pennsylvania, United States, 15644
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Jersey Shore, Pennsylvania, United States, 17740
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Lansdale, Pennsylvania, United States, 19446
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Melrose Park, Pennsylvania, United States, 19027
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Philadelphia, Pennsylvania, United States, 19153-2326
United States, South Carolina
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Charleston, South Carolina, United States, 29412
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North Myrtle Beach, South Carolina, United States, 29582
United States, Texas
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Beaumont, Texas, United States, 77701
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Dallas, Texas, United States, 75246
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Houston, Texas, United States, 77079
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Houston, Texas, United States, 77008
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Kaufman, Texas, United States, 75142
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San Antonio, Texas, United States, 78229
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San Marcos, Texas, United States, 78666
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Stephenville, Texas, United States, 76401
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Webster, Texas, United States, 77598
United States, Vermont
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South Burlington, Vermont, United States, 05403
United States, Virginia
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Richmond, Virginia, United States, 23294
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Richmond, Virginia, United States, 23225-4017
United States, Washington
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Federal Way, Washington, United States, 98003
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Spokane, Washington, United States, 99207
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Spokane, Washington, United States, 99204
United States, West Virginia
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Burnsville, West Virginia, United States, 26335
Argentina
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Capital Federal, Buenos Aires, Argentina, C1181ACH
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Buenos Aires, Argentina, C1426ABP
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
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Wollongong, New South Wales, Australia, 2500
Australia, Queensland
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Herston, Queensland, Australia, 4029
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Melbourne, Victoria, Australia, 3004
Austria
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Vienna, Austria, A-1130
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Wien, Austria, A-1030
Belgium
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Bornem, Belgium, 2880
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Brussels, Belgium, 1070
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Edegem, Belgium, 2650
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Genk, Belgium, 3600
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Leuven, Belgium, 3000
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Liège 1, Belgium, 4000
Brazil
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Belo Horizonte, MG, Brazil, 30150-221
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Porto Alegre, RS, Brazil, 90035-170
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Sao Paulo, SP, Brazil, 04025-011
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Sao Paulo, SP, Brazil, 01244-030
Canada, Alberta
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Calgary, Alberta, Canada, T3B 0M3
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Calgary, Alberta, Canada, T2T 5C7
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Calgary, Alberta, Canada, T2L 1K8
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Edmonton, Alberta, Canada, T5J 3N4
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Edmonton, Alberta, Canada, T6G 2S2
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Edmonton, Alberta, Canada, T6G 2C8
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Red Deer, Alberta, Canada, T6N 6V7
Canada, British Columbia
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Victoria, British Columbia, Canada, V8R 1J8
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1A 2E2
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
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Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
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Corunna, Ontario, Canada, N0N 1G0
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London, Ontario, Canada, N6A 4V2
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Mississauga, Ontario, Canada, L5M 2V8
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Oakville, Ontario, Canada, L6H 3P1
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Ottawa, Ontario, Canada, K1H 1A2
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Smiths Falls, Ontario, Canada, K7A 4W8
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Thornhill, Ontario, Canada, L4J 8L7
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Toronto, Ontario, Canada, M4R 2G4
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Toronto, Ontario, Canada, M4N-3M5
Canada, Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
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Gatineau, Quebec, Canada, J8Y 6S9
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Greenfield Park, Quebec, Canada, J4V 2H1
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Laval, Quebec, Canada, H7T 2P5
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Montreal, Quebec, Canada, H3A 1A1
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Sherbrooke, Quebec, Canada, J1H 5N4
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Trois Rivieres, Quebec, Canada, G8T 7A1
Croatia
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Zagreb, Croatia, 10 000
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Zagreb, Croatia, 10000
Denmark
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Aarhus, Denmark, 8000
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Copenhagen, Denmark, 2400
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Herning, Denmark, 7400
Estonia
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Viljandi, Viljandi mk., Estonia, 71024
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Pärnu, Estonia, 80018
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Tallinn, Estonia, 10318
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Tallinn, Estonia, 13415
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Tallinn, Estonia, 11625
Finland
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Kuopio, Finland, 70210
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Lahti, Finland, 15110
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Lohja, Finland, 08200
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Oulu, Finland, 90100
France
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Amiens cedex 1, France, 80094
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Armentieres, France, 59427
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Besancon, France, 25030
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Bondy Cedex, France, 93143
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Brest CEDEX, France, 29609
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Chartres, France, 28000
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Corbeil-Essonnes, France, 91100
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Lorient Cedex, France, 56322
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Paris Cedex 10, France, 75475
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Paris Cedex 18, France, 75877
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Rennes Cedex 2, France, 35203
Germany
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Altenburg, Germany, 04600
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Aschaffenburg, Germany, 63739
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Bad Doberan, Germany, 18209
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Berlin, Germany, 10115
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Berlin, Germany, 13355
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Bonn, Germany, 53179
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Chemnitz, Germany, 09130
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Datteln, Germany, 45711
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Dortmund, Germany, 44339
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Eisenach, Germany, 99817
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Emden, Germany, 26725
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Essen, Germany, 45329
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Falkensee, Germany, 14612
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Friedberg, Germany, 86316
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Fulda, Germany, 36037
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Hamburg, Germany, 21073
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Hohenmoelsen, Germany, 06679
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Leipzig, Germany, 04103
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Leverkusen, Germany, 51371
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Marl, Germany, 45770
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Meissen, Germany, 01662
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Mittweida, Germany, 09648
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Muenchen, Germany, D-80469
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Muenster, Germany, 48153
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Muenster, Germany, 48145
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Neuss, Germany, 41460
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Reinfeld, Germany, 23858
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Riesa, Germany, 01587
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Rossach, Germany, 96269
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Schluechtern, Germany, 36381
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Siegen, Germany, 57072
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Suhl, Germany, 98529
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Surwold, Germany, 26903
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Villingen-Schwenningen, Germany, 78054
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Wangen, Germany, 88239
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Wangen / Allgaeu, Germany, 88239
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Warburg, Germany, 34414
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Wiesbaden, Germany, 65191
Greece
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Athens, Greece, 15123
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Athens, Greece, 11527
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Thessaloniki, Greece, 546 36
Italy
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Catania, Italy, 95122
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Genova, Italy, 16132
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Milano, Italy, 20132
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Napoli, Italy, 80131
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Padova, Italy, 35128
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Palermo, Italy, 90127
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Roma, Italy, 00133
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Udine, Italy, 33100
Mexico
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Guadalajara, Jalisco, Mexico, 44340
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Monterrey, Nuevo Leon, Mexico, 64460
Netherlands
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's Hertogenbosch, Netherlands, 5211 RW
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Amsterdam, Netherlands, 1105 AZ
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Beek, Netherlands, 6191 JW
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Eindhoven, Netherlands, 5631 BM
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Venlo, Netherlands, 5912 BL
Norway
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Fornebu, Norway, 1364
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Honefoss, Norway, 3515
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Skedsmokorset, Norway, N-2020
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Stavanger, Norway, 4068
Poland
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Lask, Poland, 98-100
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Lodz, Poland, 93-338
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Lublin, Poland, 20-536
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Warszawa, Poland, 02-097
Portugal
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Aveiro, Portugal, 3814-096
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Lisboa, Portugal, 1349-019
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Lisboa, Portugal, 1250-203
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Porto, Portugal, 4099-001
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Torres Vedras, Portugal, 2560-324
Slovakia
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Banska Bystrica, Slovakia, 975 17
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Bratislava, Slovakia, 811 08
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Martin, Slovakia, 036 01
South Africa
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Houghton, Gauteng, South Africa, 2198
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Umhlanga Rocks, KwaZulu Natal, South Africa, 4320
Spain
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Santiago de Compostela, A Coruña, Spain, 15706
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Badalona, Barcelona, Spain, 08916
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Las Palmas, Las Palmas de Gran Canaria, Spain, 35016
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La Laguna, Santa Cruz de Tenerife, Spain, 38320
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Alzira, Valencia, Spain, 46600
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Bilbao, Vizcaya, Spain, 48013
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Barcelona, Spain, 08036
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Granada, Spain, 18012
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Madrid, Spain, 28935
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Malaga, Spain, 07300
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Sevilla, Spain, 41014
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Valencia, Spain, 46015
Sweden
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Boras, Sweden, 503 30
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Forshaga, Sweden, 667 32
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Goteborg, Sweden, 41665
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Goteborg, Sweden, 412 55
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Göteborg, Sweden, 417 17
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Harnosand, Sweden, 871 82
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Helsingborg, Sweden, 251 87
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Linkoping, Sweden, 581 85
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Malmo, Sweden, 211 52
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Stockholm, Sweden, 171 76
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Vaxjo, Sweden, 351 85
United Kingdom
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Penzance, Cornwall, United Kingdom, TR18 4JH
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St. Austell, Cornwall, United Kingdom, PL26 7RL
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Plymouth, Devon, United Kingdom, PL6 8BX
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Letchworth, Hertfordshire, United Kingdom, SG6 4UB
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Ashford, Middlesex, United Kingdom, TW15 3EA
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Headington, Oxford, United Kingdom, OX3 7LJ
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Weybridge, Surrey, United Kingdom, KT15 2BH
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Woking, Surrey, United Kingdom, GU22 7EY
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Rugby, Warwickshire, United Kingdom, CV22 5PX
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Warminster, Wiltshire, United Kingdom, BA12 9AA
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Sheffield, Yorkshire, United Kingdom, S7 2DW
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Bath, United Kingdom, BA2 4BY
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Bath, United Kingdom, BA2 3HT
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Birmingham, United Kingdom, B37 7TR
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Birmingham, United Kingdom, B9 5SS
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Bolton, United Kingdom, BL3 6TL
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Canterbury, United Kingdom, CT1 3HX
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Leicester, United Kingdom, LE1 5WW
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Newcastle-upon-Tyne, United Kingdom, NE15 6TQ
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Salford, United Kingdom, M6 8HD
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Westbury, United Kingdom, BA13 3JD
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00734591     History of Changes
Other Study ID Numbers: A2171121
Study First Received: August 12, 2008
Results First Received: September 24, 2012
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Observational Study Exubera

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014