Follow-Up Study for Exubera

NCT00734591 | Completed Results

• 1 other identifier: A2171121
• Study Type: observational
• Target: 7,439
• Locations: 23 countries
• Sites: 311

Brief Summary

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.

Conditions

Diabetes Mellitus

Keywords

Observational Study Exubera

Outcome Measures

Primary Outcomes (1)

• Rate of Primary Lung Cancer Mortality

  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.

  Baseline from original trial up to Year 2 of this study

Secondary Outcomes (3)

• Rate of Primary Lung Cancer Mortality Among Former Smokers

  Baseline from original trial up to Year 2 of this study

• Rate of All-cause Mortality

  Baseline from original trial up to Year 2 of this study

• Rate of Primary Lung Cancer Diagnosis

  Baseline from original trial up to Year 2 of this study

Study Arms (2)

Previously treated with Exubera

Drug: Exubera

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

Interventions

Exubera DRUG

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 Exubera

Randomized diabetes therapy OTHER

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).

Previously treated with comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• Participated in an investigational study of an unapproved drug since completing the Exubera trial
• Ever used an other (non-Exubera) inhaled insulin

Sponsors & Collaborators

• Pfizer: lead

Study Sites (321)

Pfizer Investigational Site

Bay Minette, Alabama, 36507, United States

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Graysville, Alabama, 35073, United States

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Pell City, Alabama, 35125, United States

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Pell City, Alabama, 35128, United States

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Glendale, Arizona, 85306, United States

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Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85016, United States

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Phoenix, Arizona, 85028, United States

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Phoenix, Arizona, 85051, United States

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Forrest City, Arkansas, 72335, United States

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Berkeley, California, 94705, United States

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Concord, California, 94520, United States

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El Cajon, California, 92019, United States

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Encino, California, 91436, United States

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Fresno, California, 93720, United States

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Fullerton, California, 92835, United States

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Huntington Beach, California, 92648, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90073, United States

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Rolling Hills Estates, California, 90274, United States

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San Diego, California, 92120, United States

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San Diego, California, 92128, United States

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San Jose, California, 95116, United States

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Santa Ana, California, 92704, United States

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Santa Barbara, California, 93105, United States

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Tustin, California, 92780, United States

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Denver, Colorado, 80206, United States

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Denver, Colorado, 80209, United States

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Denver, Colorado, 80220, United States

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Golden, Colorado, 80401, United States

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Longmont, Colorado, 80501, United States

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Milford, Connecticut, 06460, United States

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Newark, Delaware, 19713, United States

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

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Washington D.C., District of Columbia, 20307, United States

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Boca Raton, Florida, 33433, United States

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Chiefland, Florida, 32626, United States

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Green Cove Springs, Florida, 32043, United States

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Kissimmee, Florida, 34743, United States

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Lake City, Florida, 32025, United States

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Lake Mary, Florida, 32746, United States

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Miami, Florida, 33136, United States

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Opa-locka, Florida, 33054-3818, United States

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Saint Cloud, Florida, 34769, United States

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Tampa, Florida, 33624, United States

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West Palm Beach, Florida, 33401, United States

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Atlanta, Georgia, 30318-2513, United States

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Atlanta, Georgia, 30342, United States

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Conyers, Georgia, 30013, United States

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Decatur, Georgia, 30035, United States

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Honolulu, Hawaii, 96813, United States

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Honolulu, Hawaii, 96814, United States

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Hayden Lake, Idaho, 83835, United States

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Greenville, Illinois, 62246, United States

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Normal, Illinois, 61761, United States

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Olympia Fields, Illinois, 60461, United States

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Springfield, Illinois, 62704, United States

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Fishers, Indiana, 46038, United States

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Indianapolis, Indiana, 46229, United States

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Indianapolis, Indiana, 46254-5472, United States

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Des Moines, Iowa, 50314, United States

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Des Moines, Iowa, 50315, United States

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Dubuque, Iowa, 52002, United States

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Wichita, Kansas, 67203, United States

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Louisville, Kentucky, 40213, United States

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Louisville, Kentucky, 40258, United States

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Mount Sterling, Kentucky, 40353, United States

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Baltimore, Maryland, 21204, United States

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Elkton, Maryland, 21921, United States

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Glen Burnie, Maryland, 21061, United States

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Wheaton, Maryland, 20902, United States

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Boston, Massachusetts, 02114, United States

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Springfield, Massachusetts, 01105, United States

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Ann Arbor, Michigan, 48104, United States

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Clinton, Michigan, 49236, United States

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Flint, Michigan, 48532, United States

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Muskegon, Michigan, 49444, United States

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Saint Cloud, Minnesota, 56301, United States

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Kansas City, Missouri, 64116, United States

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Springfield, Missouri, 65807, United States

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Incline Village, Nevada, 89452, United States

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Las Vegas, Nevada, 89128, United States

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Belvidere, New Jersey, 07823, United States

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New Brunswick, New Jersey, 08901, United States

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Albuquerque, New Mexico, 87106, United States

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Albany, New York, 12208, United States

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Babylon, New York, 11702, United States

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Brooklyn, New York, 11224, United States

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Minneola, New York, 11501, United States

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New Hartford, New York, 13413, United States

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Syracuse, New York, 13210, United States

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Williamsville, New York, 14221, United States

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Asheboro, North Carolina, 27203, United States

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Charlotte, North Carolina, 28227, United States

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Durham, North Carolina, 27713, United States

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Morehead City, North Carolina, 28557-3126, United States

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Raleigh, North Carolina, 27609, United States

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Tabor City, North Carolina, 28463, United States

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Winston-Salem, North Carolina, 27103, United States

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Columbus, Ohio, 43207, United States

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Dayton, Ohio, 45419, United States

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Kettering, Ohio, 45429, United States

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Marietta, Ohio, 45750, United States

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Portland, Oregon, 97210, United States

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Portland, Oregon, 97232, United States

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Fogelsville, Pennsylvania, 18051, United States

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Hanover, Pennsylvania, 17331, United States

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Harrisburg, Pennsylvania, 17112, United States

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Jeannette, Pennsylvania, 15644, United States

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Jersey Shore, Pennsylvania, 17740, United States

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Lansdale, Pennsylvania, 19446, United States

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Melrose Park, Pennsylvania, 19027, United States

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Philadelphia, Pennsylvania, 19153-2326, United States

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Charleston, South Carolina, 29412, United States

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North Myrtle Beach, South Carolina, 29582, United States

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Beaumont, Texas, 77701, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77008, United States

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Houston, Texas, 77079, United States

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Kaufman, Texas, 75142, United States

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San Antonio, Texas, 78229, United States

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San Marcos, Texas, 78666, United States

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Stephenville, Texas, 76401, United States

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Webster, Texas, 77598, United States

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South Burlington, Vermont, 05403, United States

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Richmond, Virginia, 23225-4017, United States

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Richmond, Virginia, 23294, United States

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Federal Way, Washington, 98003, United States

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Spokane, Washington, 99204, United States

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Spokane, Washington, 99207, United States

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Burnsville, West Virginia, 26335, United States

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Capital Federal, Buenos Aires, C1181ACH, Argentina

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Buenos Aires, C1426ABP, Argentina

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Camperdown, New South Wales, 2050, Australia

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Wollongong, New South Wales, 2500, Australia

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Herston, Queensland, 4029, Australia

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Box Hill, Victoria, 3128, Australia

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Melbourne, Victoria, 3004, Australia

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Vienna, A-1030, Austria

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Vienna, A-1130, Austria

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Bornem, 2880, Belgium

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Brussels, 1070, Belgium

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Edegem, 2650, Belgium

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Genk, 3600, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Belo Horizonte, Minas Gerais, 30150-221, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-170, Brazil

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São Paulo, São Paulo, 01244-030, Brazil

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São Paulo, São Paulo, 04025-011, Brazil

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Calgary, Alberta, T2L 1K8, Canada

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Calgary, Alberta, T2T 5C7, Canada

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Calgary, Alberta, T3B 0M3, Canada

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Edmonton, Alberta, T5J 3N4, Canada

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Edmonton, Alberta, T6G 2C8, Canada

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Edmonton, Alberta, T6G 2S2, Canada

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Red Deer, Alberta, T6N 6V7, Canada

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Victoria, British Columbia, V8R 1J8, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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St. John's, Newfoundland and Labrador, A1A 2E2, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Corunna, Ontario, N0N 1G0, Canada

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London, Ontario, N6A 4V2, Canada

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Mississauga, Ontario, L5M 2V8, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Ottawa, Ontario, K1H 1A2, Canada

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Smiths Falls, Ontario, K7A 4W8, Canada

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Thornhill, Ontario, L4J 8L7, Canada

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Toronto, Ontario, M4N-3M5, Canada

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Toronto, Ontario, M4R 2G4, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Gatineau, Quebec, J8Y 6S9, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Laval, Quebec, H7T 2P5, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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Zagreb, 10 000, Croatia

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Zagreb, 10000, Croatia

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Aarhus, 8000, Denmark

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Copenhagen, 2400, Denmark

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Herning, 7400, Denmark

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Viljandi, Viljandi Mk., 71024, Estonia

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Pärnu, 80018, Estonia

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Tallinn, 10318, Estonia

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Tallinn, 11625, Estonia

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Tallinn, 13415, Estonia

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Kuopio, 70210, Finland

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Lahti, 15110, Finland

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Lohja, 08200, Finland

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Oulu, 90100, Finland

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Corbeil-Essonnes, France, 91100, France

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Amiens, 80094, France

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Armentières, 59427, France

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Besançon, 25030, France

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Bondy, 93143, France

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Brest, 29609, France

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Chartres, 28000, France

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Lorient, 56322, France

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Paris, 75475, France

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Paris, 75877, France

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Rennes, 35203, France

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Altenburg, 04600, Germany

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Aschaffenburg, 63739, Germany

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Bad Doberan, 18209, Germany

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Berlin, 10115, Germany

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Berlin, 13355, Germany

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Bonn, 53179, Germany

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Chemnitz, 09130, Germany

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Datteln, 45711, Germany

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Dortmund, 44339, Germany

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Eisenach, 99817, Germany

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Emden, 26725, Germany

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Essen, 45329, Germany

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Falkensee, 14612, Germany

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Friedberg, 86316, Germany

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Fulda, 36037, Germany

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Hamburg, 21073, Germany

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Hohenmölsen, 06679, Germany

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Leipzig, 04103, Germany

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Leverkusen, 51371, Germany

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Marl, 45770, Germany

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Meissen, 01662, Germany

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Mittweida, 09648, Germany

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München, D-80469, Germany

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Münster, 48145, Germany

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Münster, 48153, Germany

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Neuss, 41460, Germany

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Reinfeld, 23858, Germany

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Riesa, 01587, Germany

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Rossach, 96269, Germany

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Schlüchtern, 36381, Germany

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Siegen, 57072, Germany

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Suhl, 98529, Germany

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Surwold, 26903, Germany

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Villingen-Schwenningen, 78054, Germany

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Wangen, 88239, Germany

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Wangen / Allgaeu, 88239, Germany

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Warburg, 34414, Germany

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Wiesbaden, 65191, Germany

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Athens, 11527, Greece

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Athens, 15123, Greece

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Thessaloniki, 546 36, Greece

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Catania, 95122, Italy

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Genova, 16132, Italy

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Milan, 20132, Italy

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Napoli, 80131, Italy

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Padua, 35128, Italy

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Palermo, 90127, Italy

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Roma, 00133, Italy

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Udine, 33100, Italy

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Guadalajara, Jalisco, 44340, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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's-Hertogenbosch, 5211 RW, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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Beek, 6191 JW, Netherlands

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Eindhoven, 5631 BM, Netherlands

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Venlo, 5912 BL, Netherlands

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Fornebu, 1364, Norway

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Hønefoss, 3515, Norway

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Skedsmokorset, N-2020, Norway

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Stavanger, 4068, Norway

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Lodz, 93-338, Poland

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Lublin, 20-536, Poland

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Warsaw, 02-097, Poland

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Łask, 98-100, Poland

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Aveiro, 3814-096, Portugal

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Lisbon, 1250-203, Portugal

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Lisbon, 1349-019, Portugal

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Porto, 4099-001, Portugal

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Torres Vedras, 2560-324, Portugal

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Banská Bystrica, 975 17, Slovakia

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Bratislava, 811 08, Slovakia

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Martin, 036 01, Slovakia

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Houghton Estate, Gauteng, 2198, South Africa

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Umhlanga, KwaZulu-Natal, 4320, South Africa

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Santiago de Compostela, A Coruña, 15706, Spain

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Badalona, Barcelona, 08916, Spain

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Barcelona, Barcelona, 08036, Spain

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Granada, Granada, 18012, Spain

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Las Palmas, Las Palmas de Gran Canaria, 35016, Spain

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Madrid, Madrid, 28935, Spain

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Málaga, Malaga, 07300, Spain

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San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

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Seville, Sevilla, 41014, Spain

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Alzira, Valencia, 46600, Spain

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Valencia, Valencia, 46015, Spain

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Bilbao, Vizcaya, 48013, Spain

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Borås, 503 30, Sweden

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Forshaga, 667 32, Sweden

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Gothenburg, 412 55, Sweden

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Gothenburg, 41665, Sweden

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Gothenburg, 417 17, Sweden

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Härnösand, 871 82, Sweden

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Helsingborg, 251 87, Sweden

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Linköping, 581 85, Sweden

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Malmo, 211 52, Sweden

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Stockholm, 171 76, Sweden

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Vaxjo, 351 85, Sweden

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Penzance, Cornwall, TR18 4JH, United Kingdom

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St Austell, Cornwall, PL26 7RL, United Kingdom

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Plymouth, Devon, PL6 8BX, United Kingdom

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Letchworth Garden City, Hertfordshire, SG6 4UB, United Kingdom

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Ashford, Middlesex, TW15 3EA, United Kingdom

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Headington, Oxford, OX3 7LJ, United Kingdom

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Weybridge, Surrey, KT15 2BH, United Kingdom

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Woking, Surrey, GU22 7EY, United Kingdom

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Rugby, Warwickshire, CV22 5PX, United Kingdom

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Warminster, Wiltshire, BA12 9AA, United Kingdom

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Sheffield, Yorkshire, S7 2DW, United Kingdom

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Bath, BA2 3HT, United Kingdom

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Bath, BA2 4BY, United Kingdom

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Birmingham, B37 7TR, United Kingdom

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Birmingham, B9 5SS, United Kingdom

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Bolton, BL3 6TL, United Kingdom

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Canterbury, CT1 3HX, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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Newcastle upon Tyne, NE15 6TQ, United Kingdom

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Salford, M6 8HD, United Kingdom

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Westbury, BA13 3JD, United Kingdom

Location

Related Publications (1)

• Gatto NM, Koralek DO, Bracken MB, Duggan WT, Lem J, Klioze S, Koch GG, Wise RA, Cohen RB, Jackson NC. Lung Cancer-Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results. Diabetes Care. 2019 Sep;42(9):1708-1715. doi: 10.2337/dc18-2529. Epub 2019 Jul 22.

  PMID: 31331907 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Exubera

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Detection and/or reporting bias possible in continuous analysis (presented here) of lung cancer mortality and lung cancer incidence endpoints. Study had insufficient power to draw clear statistical conclusions due to small number of events.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: October 23, 2012
• Results First Posted: October 23, 2012

Record last verified: 2012-09

Locations

IT (8); AU (2); CR (2); FR (11); DE (38); FI (4); PL (4); CA (28); ME (2); US (131); SL (3); ZA (2); AR (2); DK (3); ES (12); GR (3); NL (5); BR (4); BE (6); NO (4); SE (11); GB (21); PT (5)