A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease
NCT ID: NCT03131453
Last Updated: 2021-08-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
1145 participants
INTERVENTIONAL
2017-08-03
2020-03-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CNP520 50 mg
50 mg capsule taken orally once daily
CNP520 50mg
50 mg capsule
CNP520 15 mg
15 mg capsule taken orally once daily
CNP520 15mg
15 mg capsule
Placebo
Matching placebo to 15 and 50 mg CNP520 taken orally once daily
Matching placebo
Matching placebo for 15 and 50 mg capsules
Interventions
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CNP520 50mg
50 mg capsule
CNP520 15mg
15 mg capsule
Matching placebo
Matching placebo for 15 and 50 mg capsules
Eligibility Criteria
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Inclusion Criteria
* Male or female, age 60 to 75 years inclusive. Females must be considered post-menopausal and not of child bearing potential
* Cognitively unimpaired as evaluated by memory tests performed at screening.
* Participant's willingness to have a study partner.
* Carrier of at least one APOE4 gene if Heterozygotes, elevated brain amyloid (as measured by CSF Abeta or amyloid PET imaging).
Exclusion Criteria
* Current medical or neurological condition that could have impacted cognition or performance on cognitive assessments.
* Advanced, severe progressive or unstable disease that could have interfered with the safety, tolerability and study assessments, or put the participant at special risk.
* History of malignancy of any organ system, treated or untreated, within the past 60 months.
* Indication for, or current treatment with ChEIs and/or another AD treatment (e.g. memantine).
* Contraindication or intolerance to MRI.
* Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator might be a leading cause to future cognitive decline, could have posed a risk to the participant, or could have prevented a satisfactory MRI assessment for safety monitoring.
* Suicidal Ideation in the past six months, or Suicidal Behavior in the past two years.
* A positive drug screen at Screening, if, in the Investigator's opinion, was is due to drug abuse.
* Significantly abnormal laboratory results at Screening, not as a result of a temporary condition.
* Current clinically significant ECG findings.
* Clinically relevant depigmenting or hypopigmenting conditions (e.g. albinism, vitiligo) or active / history of chronic urticaria in the past year.
60 Years
75 Years
ALL
Yes
Sponsors
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Amgen
INDUSTRY
Banner Alzheimer's Institute
OTHER
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Banner Alzheimer's Institute, 901 East Willetta Street
Phoenix, Arizona, United States
Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B
Sun City, Arizona, United States
Novartis Investigative Site
Tucson, Arizona, United States
ATP Clinical Research Inc, 3151 Airway Avenue T 3
Costa Mesa, California, United States
Irvine Center for Clinical Res, 2515 McCabe Way
Irvine, California, United States
Torrance Clinical Research Institute, 25043 Narbonne Avenue
Lomita, California, United States
Novartis Investigative Site
Oxnard, California, United States
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Palo Alto, California, United States
Novartis Investigative Site
San Diego, California, United States
Syrentis Clinical Research, 1401 N Tustin Ave, Suite 130
Santa Ana, California, United States
Novartis Investigative Site
Sebastopol, California, United States
Novartis Investigative Site
Sherman Oaks, California, United States
Mountain Neurological Research, 350 Market Street, Suite 316
Basalt, Colorado, United States
Colorado Springs Neurological, 2312 North Nevada Avenue, Suite 100
Colorado Springs, Colorado, United States
Denver Neurological Clinic, 950 E Harvard Ave
Denver, Colorado, United States
Yale University, One Church Street, Suite 600
New Haven, Connecticut, United States
Novartis Investigative Site
Stamford, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Atlantis, Florida, United States
Quantum Laboratories
Deerfield Beach, Florida, United States
Brain Matters Research, Inc., 800 NW 17th Avenue
Delray Beach, Florida, United States
Infinity Clinical Research LLC, 4925 Sheridan Street, Suite 200
Hollywood, Florida, United States
Alzheimer's Research and Treatment Center, 5065 State Road 7, Suite 102
Lake Worth, Florida, United States
Meridien Research, 2300 Maitland center, Pkwy Ste 230
Maitland, Florida, United States
Novartis Investigative Site
Melbourne, Florida, United States
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Merritt Island, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
New Horizon Research Center, 11880 SW 40 St., Suite 405
Miami, Florida, United States
Miami-Dade Medical Research, 8955 SW 87 CT, Suite 112
Miami, Florida, United States
Novartis Investigative Site
Miami Beach, Florida, United States
Compass Research, LLC,100 West Gore Street, Suite 202
Orlando, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Palm Beach Gardens, Florida, United States
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Port Orange, Florida, United States
Roskamp Institute, Inc., 2040 Whitfield Avenue
Sarasota, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Decatur, Georgia, United States
Hawaii Pacific Neuroscience, 2230 Liliha st 104
Honolulu, Hawaii, United States
Advanced Clinical Research, 2950 E Magic View Dr, Suite 182
Meridian, Idaho, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
Alexian Brothers Neuroscience, 800 Biesterfield Rd, Neuroscience Institute Brock
Elk Grove Village, Illinois, United States
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Indianapolis, Indiana, United States
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Fairway, Kansas, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Bangor, Maine, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
QUEST Research Institute, 28595 Orchard Lake Road, Suite 301
Farmington Hills, Michigan, United States
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Kalamazoo, Michigan, United States
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Rochester, Minnesota, United States
Hattiesburg Clinic, 415 South 28th Avenue
Hattiesburg, Mississippi, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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West Long Branch, New Jersey, United States
Albuquerque Neuroscience, 101 Hospital Loop ne, 209 209
Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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East Syracuse, New York, United States
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Latham, New York, United States
NYU Langone Medical Center, 145 East 32nd Street, 2nd Floor, Room 226
New York, New York, United States
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Orangeburg, New York, United States
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Rochester, New York, United States
ANI Neurology, PLLC dba Alzhe, 7809 Sardis Road
Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
Tulsa Clinical Research LLC, 1705 E 19th ST., STE 406/408
Tulsa, Oklahoma, United States
Summit Research Network, 2701 NW Vaughn St, Suite 350
Portland, Oregon, United States
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Portland, Oregon, United States
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Jenkintown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
Abington Neurological Associate Ltd., 2325 Maryland Road, Suite 100
Willow Grove, Pennsylvania, United States
Rhode Island Hospital and Memory Research Institute, 1018 Waterman Ave
East Providence, Rhode Island, United States
Butler Hospital, 345 Blackstone Blvd.
Providence, Rhode Island, United States
Roper Hospital, 316 Calhoun Street 5th Floor
Charleston, South Carolina, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Bennington, Vermont, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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CABA, Buenos Aires, Argentina
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Buenos Aires, , Argentina
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Darlinghurst, New South Wales, Australia
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Heidelberg West, Victoria, Australia
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Nedlands, Western Australia, Australia
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Ghent, , Belgium
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Leuven, , Belgium
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Kelowna, British Columbia, Canada
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Kentville, Nova Scota, Canada
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Halifax, Nova Scotia, Canada
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Ottawa, Ontario, Canada
Toronto Memory Program, 1 Valleybrook Drive Suite 400
Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Gatineau, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Québec, Quebec, Canada
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Santiago, , Chile
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Santiago, , Chile
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Shanghai, Shanghai Municipality, China
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Beijing, , China
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Guangdong, , China
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Kuopio, , Finland
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Turku, , Finland
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Strasbourg, Cedex, France
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Lille, , France
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Paris, , France
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Rouen, , France
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Toulouse, , France
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Villeurbanne, , France
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Bayreuth, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Leipzig, , Germany
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Mannheim, , Germany
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Siegen, , Germany
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Kopavogur, , Iceland
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Ashkelon, , Israel
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Haifa, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Brescia, BS, Italy
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Rome, Lazio, Italy
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Monza, MB, Italy
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Milan, , Italy
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Tōon, Ehime, Japan
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Fukuoka, Fukuoka, Japan
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Yokohama, Kanagawa, Japan
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Suita, Osaka, Japan
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Bunkyo Ku, Tokyo, Japan
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Bunkyo Ku, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Chiba, , Japan
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Osaka, , Japan
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Mexico City, Mexico CP, Mexico
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Monterrey, Nuevo León, Mexico
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Culiacán, Sinaloa, Mexico
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's-Hertogenbosch, North Brabant, Netherlands
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Amsterdam, , Netherlands
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Torres Vedras, Lisbon District, Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Matosinhos Municipality, , Portugal
Inspira Clinical Research, Ave Hostos 405
San Juan, , Puerto Rico
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Singapore, , Singapore
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Rosebank, Johannesburg, South Africa
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Cape Town, Western Cape, South Africa
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George, ZAF, South Africa
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Suwon, Gyeonggi-do, South Korea
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Busan, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Terrassa, Barcelona, Spain
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Pozuelo de Alarcón, Madrid, Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Donostia / San Sebastian, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Basel, CH, Switzerland
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Kaoshiung, , Taiwan
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New Taipei City, , Taiwan
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Taipei, , Taiwan
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Exeter, Devon, United Kingdom
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Plymouth, Devon, United Kingdom
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London, GBR, United Kingdom
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Guildford, Surrey, United Kingdom
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Avon, , United Kingdom
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Birmingham, , United Kingdom
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Bristol, , United Kingdom
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Dundee, , United Kingdom
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Glasgow, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002976-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCNP520A2202J
Identifier Type: -
Identifier Source: org_study_id
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